aagl practice guidelines on the prevention of apical ... · 1 aagl practice guidelines on the...

20
AAGL Practice Guidelines on the Prevention of Apical Prolapse at the Time of 1 Benign Hysterectomy 2 Background 3 Hysterectomy is the most commonly performed gynecological surgical 4 procedure. In 2005, over 500,000 hysterectomies were performed in the United 5 States 1 ; 64% abdominally, 22% vaginally, and 14% laparoscopically [1]. Pelvic 6 organ prolapse is one of the most common reasons that hysterectomy is performed 7 [2], but evidence suggests that hysterectomy may also be a cause of future prolapse 8 [3-6]. 9 Pelvic organ prolapse may adversely impact physical, sexual and emotional 10 health. Women with symptomatic prolapse often experience altered bladder and 11 bowel function, increased pelvic pressure, diminution of sexual satisfaction, and 12 altered body image. With increasing vaginal descent, various bladder, bowel, and 13 prolapse symptoms are increased [7]. Personal and health care related costs for 14 prolapse are high, with the annual cost of ambulatory care of pelvic floor disorders 15 in the United States from 2005 to 2006 being almost $300 million [8]. Annual direct 16 costs for prolapse surgery in the United States are estimated to exceed 1 billion 17 dollars [9]. 18 Approximately 200,000 women undergo inpatient procedures for prolapse in 19 the United States each year [10], with regional and racial differences in rates of 20 surgery reported [11]. The demand for health care services related to pelvic floor 21 disorders will increase at twice the rate of the population itself [12]. The total 22

Upload: doanlien

Post on 12-Apr-2018

235 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: AAGL Practice Guidelines on the Prevention of Apical ... · 1 AAGL Practice Guidelines on the Prevention of Apical Prolapse at the Time of ... 136 vault during abdominal hysterectomy

AAGL Practice Guidelines on the Prevention of Apical Prolapse at the Time of 1 Benign Hysterectomy 2

Background 3

Hysterectomy is the most commonly performed gynecological surgical 4

procedure. In 2005, over 500,000 hysterectomies were performed in the United 5

States 1; 64% abdominally, 22% vaginally, and 14% laparoscopically [1]. Pelvic 6

organ prolapse is one of the most common reasons that hysterectomy is performed 7

[2], but evidence suggests that hysterectomy may also be a cause of future prolapse 8

[3-6]. 9

Pelvic organ prolapse may adversely impact physical, sexual and emotional 10

health. Women with symptomatic prolapse often experience altered bladder and 11

bowel function, increased pelvic pressure, diminution of sexual satisfaction, and 12

altered body image. With increasing vaginal descent, various bladder, bowel, and 13

prolapse symptoms are increased [7]. Personal and health care related costs for 14

prolapse are high, with the annual cost of ambulatory care of pelvic floor disorders 15

in the United States from 2005 to 2006 being almost $300 million [8]. Annual direct 16

costs for prolapse surgery in the United States are estimated to exceed 1 billion 17

dollars [9]. 18

Approximately 200,000 women undergo inpatient procedures for prolapse in 19

the United States each year [10], with regional and racial differences in rates of 20

surgery reported [11]. The demand for health care services related to pelvic floor 21

disorders will increase at twice the rate of the population itself [12]. The total 22

Page 2: AAGL Practice Guidelines on the Prevention of Apical ... · 1 AAGL Practice Guidelines on the Prevention of Apical Prolapse at the Time of ... 136 vault during abdominal hysterectomy

2

number of women who will have surgery for prolapse is projected to increase from 23

166,000 in 2010 to 245,970 in 2050 [13]. 24

The true prevalence of pelvic organ prolapse is difficult to ascertain because 25

many women with prolapse do not seek medical care. Various studies report the 26

prevalence of symptomatic prolapse to be between 6 and 8% among adult women 27

[14-15]. Population-based studies report that 11 to 19% of women undergo surgery 28

for prolapse or incontinence during their lifetime [16-17]. 29

Hysterectomy is associated with a risk of subsequent surgery for pelvic organ 30

prolapse[3-4], particularly when performed on women with existing prolapse [5-6]. 31

While some studies suggest that post hysterectomy prolapse is more common 32

following vaginal hysterectomy, than after the abdominal approach [4-5] it is 33

unclear if this association is due to selection bias or whether the technique of 34

vaginal hysterectomy is more prone to cause surgical trauma to the vaginal support 35

tissues. Rates of the development of post-hysterectomy prolapse are compounded 36

by the fact that there are low institutional compliance rates with evidence-based 37

guidelines to perform a concurrent suspension procedure at the time of 38

hysterectomy for existing prolapse treatment [18]. 39

Randomized trials suggest that, over the short term, cervical preservation or 40

removal does not affect the rate of subsequent pelvic organ prolapse [19-20]. 41

However, no studies have addressed the risk of pelvic organ prolapse many years 42

after surgery, which may differ after total versus supracervical hysterectomy. 43

Page 3: AAGL Practice Guidelines on the Prevention of Apical ... · 1 AAGL Practice Guidelines on the Prevention of Apical Prolapse at the Time of ... 136 vault during abdominal hysterectomy

3

The purpose of this Practice Guideline is to critically review the literature 44

and provide recommendations designed to reduce the incidence of de novo apical 45

vaginal prolapse following hysterectomy for benign disorders. 46

47

Identification and Assessment of Evidence 48

This AAGL practice guideline was produced with the following search 49

methodology; electronic resources including Medline, PubMed, EMBASE, EBM / 50

Systematic Reviews, and ISI were searched for all English publications from 1945 to 51

present related to reduction of the risk of post hysterectomy vaginal vault prolapse. 52

The MeSH terms included all subheadings, where keywords ‘apical prolapse’, 53

‘uterine prolapse’, ‘pelvic organ prolapse’, ‘vaginal vault prolapse’, or ‘hysterectomy 54

adverse effects’, occurred with ‘colpocleisis’, ‘colpopexy’, ‘vaginal suspension repair’, 55

‘culdoplasty’, ‘culdeplasty’, or ‘culdosuspension’, and ‘vaginal prolapse prevention’ 56

or ‘gynecologic surgical procedures’. Additional publications were identified from a 57

hand search of the references in the identified publications, yielding 262 articles. 58

The full text of all publications was retrieved, abstracted, tabulated and added to a 59

data table. Articles were reviewed for relevance to the topic, with 58 publications 60

identified, including 6 RCTs. All studies were assessed for methodological rigor and 61

graded according to the classification system outlined at the end of this document. 62

63

Clinical Presentation of Post-Hysterectomy Prolapse 64 65

As for any form of vaginal prolapse, post-hysterectomy vaginal vault 66

prolapse may be associated with a variety of symptoms or complaints, including 67

Page 4: AAGL Practice Guidelines on the Prevention of Apical ... · 1 AAGL Practice Guidelines on the Prevention of Apical Prolapse at the Time of ... 136 vault during abdominal hysterectomy

4

vaginal bulging, palpable or visible tissue protrusion, pressure, discomfort with 68

ambulation or activity, pelvic or back pain, dyspareunia or obstructed intercourse. 69

Alterations in the support mechanisms may be associated with lower urinary tract 70

symptoms including irritative or obstructed voiding, urinary retention and/or 71

various forms of urinary incontinence, as well as bowel complaints such as 72

obstructed defecation, fecal urgency or fecal incontinence. Symptoms of prolapse 73

correspond poorly to compartment of defect and stage of prolapse [21]. 74

Some of the potential mechanisms for post-hysterectomy prolapse include 75

surgical injury to the innervation and vascularization of the pelvic floor muscles or 76

alterations in the connective tissues. DeLancey has described a system of 3 77

integrated levels of vaginal support. Level I consists of the cardinal and uterosacral 78

ligaments, and suspends the vaginal apex. Level II consists of the endopelvic fascia 79

connections to the arcus tendineus fascia pelvis, which attaches the vagina to the 80

aponeurosis of the levator ani. Level III consists of the perineal body and includes 81

interlacing muscle fibers of the bulbospongiosus, transverse perinei, and external 82

anal sphincter. Studies suggest it is the paracolpium's vertical fibers at Level I that 83

prevent prolapse of the vaginal apex [22]. Since the uterosacral/cardinal ligament 84

complex must be divided during hysterectomy, loss of Level I support contributes to 85

subsequent prolapse of the vaginal apex. 86

87

There is increasing recognition that anterior or posterior vaginal prolapse 88

may have a significant apical component [23-24]. Even in cases where the leading 89

edge of the prolapse represents the anterior or posterior vaginal compartment, 90

Page 5: AAGL Practice Guidelines on the Prevention of Apical ... · 1 AAGL Practice Guidelines on the Prevention of Apical Prolapse at the Time of ... 136 vault during abdominal hysterectomy

5

failure to recognize or address apical prolapse is likely to lead to suboptimal 91

treatment outcomes for prolapse procedures, and perhaps to iatrogenic problems. 92

Midline colporrhaphy when undertaken for an apical support defect may 93

inadequately address the woman’s symptoms and lead to new complaints related to 94

vaginal stricture, foreshortening, or scar tissue. 95

Diagnosis of Post-Hysterectomy Prolapse 96

Assessment of women with symptoms of prolapse following hysterectomy 97

should include the fundamental targeted history and physical examination. The 98

current recommendations for objective assessment of vaginal support included use 99

of the Pelvic Organ Prolapse Quantification (POP-Q) system. The determination of 100

apical prolapse is made by measuring the location, relative to the vaginal hymen, of 101

the cuff, or hysterectomy scar (point C), during maximal valsalva and/or traction 102

during examination. Staging, by the POP-Q system, is an overall assessment 103

according to the compartment of most severe prolapse, and does not call for staging 104

of individual compartments. As described above, apical prolapse is frequently 105

associated with more severe anterior or posterior compartment prolapse, but is 106

essential to identify in order to formulate appropriate reparative strategies. Apical 107

support during the POP-Q examination may help to identify how much of the 108

observed prolapse is attributable to the apical component [25]. 109

There is debate as to whether previously described entities including vaginal 110

vault prolapse, enterocele, high rectocele or high cystocele, are indeed separate 111

entities, or are in fact different points along a spectrum of support disorders. The 112

traditional teaching that vault prolapse is a failure of support of an otherwise intact 113

Page 6: AAGL Practice Guidelines on the Prevention of Apical ... · 1 AAGL Practice Guidelines on the Prevention of Apical Prolapse at the Time of ... 136 vault during abdominal hysterectomy

6

vagina, whereas enterocele represents a failure in the fibromuscularis sheath of the 114

vagina with a herniation of peritoneum is tempting, but has not been supported 115

histologically [26]. Strict adherence to the POP-Q terminology avoids the 116

presumptive diagnosis of which organs are affected by the lack of vaginal support, 117

and focuses rather on the vaginal supports themselves. Vaginal topography has 118

been shown to correlate poorly with the location of surrounding visceral structures 119

[27]. As such, researchers and clinicians may be well served to use “anterior vaginal 120

prolapse” rather than “cystocele,” and “apical prolapse” rather than “vault prolapse” 121

or enterocele. 122

A variety of imaging studies are available to more specifically and accurately 123

describe the effects of vaginal support defects on the surrounding organ systems. 124

Ultrasound, MRI and fluoroscopy with contrast are among these modalities, which 125

may demonstrate the organs contained within the vaginal prolapse. In some cases, it 126

may be clinically useful to make such determinations; in addition, imaging studies 127

may help to identify disorders that may not be readily demonstrated during a 128

vaginal exam, such as sigmoidocele or rectal intussusception. Consequently, many 129

providers obtain some form of imaging when the symptoms often associated with 130

prolapse are not supported by, or are disproportionate to the examination findings. 131

Use of the Uterosacral Ligaments 132

Native tissue repairs of apical prolapse incorporate structures such as the 133

uterosacral ligament to reestablish pelvic supports. In 1929, Richardson described 134

cuff angle closure incorporating the broad and uterosacral ligaments to support the 135

vault during abdominal hysterectomy [28]. In 1957, the McCall culdoplasty was 136

Page 7: AAGL Practice Guidelines on the Prevention of Apical ... · 1 AAGL Practice Guidelines on the Prevention of Apical Prolapse at the Time of ... 136 vault during abdominal hysterectomy

7

described [29] in which the uterosacral ligaments are plicated in the midline, 137

incorporating the cul-de-sac peritoneum and posterior vaginal cuff. This obliterates 138

the peritoneum of the posterior cul-de-sac and elevates the vault toward the 139

plicated uterosacral ligaments. Several adaptations of this procedure have been 140

described utilizing different numbers of sutures and different points of fixation [30-141

31]. All rely on the uterosacral ligaments for support of the vaginal apex. Similar 142

procedures have been described for use during abdominal [32-33] and 143

laparoscopic[34-38] hysterectomy. These approaches have not been studied in 144

randomized trials for the prevention of post-hysterectomy prolapse. 145

146

Richardson angle stitch 147

The efficacy of this procedure was reported in a study of unembalmed 148

cadavers using hanging weights attached to the vaginal apex. Following total 149

hysterectomy, there was equal resistance following hysterectomy with a Richardson 150

angle stitch and after supracervical hysterectomy where the uterosacral ligament 151

was left intact [39]. Another cadaveric study assessing vaginal apical descent before 152

and after tying the Richardson angle stitch found that the distance of apical descent 153

was significantly reduced (cm difference and p value if mention significance) with 154

incorporation of the cardinal and uterosacral ligaments. This study suggested that 155

incorporation of this ligament complex to the vaginal angle at the time of 156

hysterectomy may prevent apical prolapse [40]. We were unable to identify any 157

published prospective studies on living patients evaluating the efficacy of this 158

technique. 159

Page 8: AAGL Practice Guidelines on the Prevention of Apical ... · 1 AAGL Practice Guidelines on the Prevention of Apical Prolapse at the Time of ... 136 vault during abdominal hysterectomy

8

160

Vaginal Procedures 161 162

There is currently only one randomized trial comparing techniques to 163

prevent vault prolapse after vaginal hysterectomy performed for non-prolapse 164

related gynecologic disease. This randomized trial [41] compared a vaginal 165

Moschowitz-type operation, peritoneal closure of the cul-de-sac, and McCall’s 166

culdoplasty for prevention of post-hysterectomy enterocele in 100 women 167

undergoing vaginal hysterectomy. The authors found significantly fewer cases of 168

posterior-apical vaginal prolapse (stage 2) three years following the McCall’s 169

culdoplasty 2/32 (6%) than with either peritoneal closure 13/33 (39%) or the 170

vaginal Moschowitz procedure 10/33 (30%) (p=.004). 171

Colombo and Milani performed a retrospective case-control study comparing 172

62 women with advanced uterovaginal prolapse who underwent sacrospinous 173

fixation or McCall culdoplasty for the prevention of post-hysterectomy vault 174

prolapse. Although the investigators reported fewer recurrences at any vaginal site 175

(27% vs 15%) in the McCall group 4 - 9 years postoperatively, the results did not 176

reach statistical significance [42]. 177

Several case series have evaluated attachment of the vaginal cuff to the 178

uterosacral ligaments for the prevention of vaginal vault prolapse after 179

hysterectomy performed for uterovaginal prolapse (rather than for prolapse 180

prevention at the time of hysterectomy for non-prolapse related gynecologic 181

disease). Inmon described reattaching the apex to plicated, shortened cardinal-182

uterosacral ligaments after vaginal hysterectomy in 106 women with grade 2 (to the 183

Page 9: AAGL Practice Guidelines on the Prevention of Apical ... · 1 AAGL Practice Guidelines on the Prevention of Apical Prolapse at the Time of ... 136 vault during abdominal hysterectomy

9

introitus) to 4 (complete) prolapse. While only 46/106 patients were followed to 2 184

years, the authors reported no recurrences. In a series of 112 patients who had 185

attachment of the cuff to the cardinal and uterosacral ligaments and high 186

obliteration of the cul-de-sac to prevent post-hysterectomy enterocele [43], no cases 187

of post-hysterectomy enterocele developed from 7 to 42 months after the 188

procedure. Chene el al. retrospectively evaluated the outcomes of 185 women who 189

underwent TVH and modified McCall culdoplasty for “mild to moderate hysterocele” 190

at their institution. They reported 89.2% with stage 0 prolapse at the apex 2 years 191

after surgery [44]. Given retrospectively reviewed 68 patients 2 - 22 years (average 192

7 years) after McCall culdoplasty performed for moderate to severe apical prolapse 193

and noted only 2 “failures” (although this was not defined)[45]. Hoffman reported a 194

ureteral obstruction rate of 4.5% in a series of 67 patients undergoing high McCall 195

culdoplasty over a 4-year period. All were recognized and resolved intraoperatively 196

[46]. While these case series suggest that the uterosacral ligaments can be 197

successfully utilized to prevent vaginal vault prolapse after hysterectomy done for 198

uterovaginal prolapse, they do not specifically address the issue of preventing 199

prolapse during hysterectomy for non-prolapse indications. 200

With uterosacral ligament suspension (USLS), the vaginal cuff is reattached 201

to the proximal uterosacral ligaments without plicating the uterosacral ligaments or 202

obliterating the cul-de-sac. There are currently no data on the use of USLS to 203

prevent vault prolapse following hysterectomy performed for non-prolapse 204

indications. We therefore reviewed articles that examined the efficacy of uterosacral 205

ligament suspension performed at the time of hysterectomy for prolapse in addition 206

Page 10: AAGL Practice Guidelines on the Prevention of Apical ... · 1 AAGL Practice Guidelines on the Prevention of Apical Prolapse at the Time of ... 136 vault during abdominal hysterectomy

10

to those evaluating prophylactic uterosacral ligament suspension performed to 207

prevent post hysterectomy vault prolapse. 208

Laparoscopic Procedures 209

The only study evaluating laparoscopic uterosacral ligament suspension is a 210

retrospective comparison of 96 patients undergoing vaginal uterosacral ligament 211

suspension to 22 undergoing laparoscopic uterosacral ligament suspension found 212

no significant difference in recurrent apical prolapse (6% in the vaginal group and 213

0% in the laparoscopic group) [47]. This study identified a 4% rate of ureteral 214

compromise recognized intraoperatively in the vaginal group, with 0% in the 215

laparoscopic group, although this was not statistically significant. 216

Abdominal Procedures 217

We identified one retrospective study evaluating 250 women having 218

prophylactic uterosacral ligament suspension to prevent post-hysterectomy vault 219

prolapse at the time of abdominal hysterectomy [32]. This study reports only a 220

single complication (a rectovaginal hematoma that resolved spontaneously) and no 221

cases of postoperative vaginal vault prolapse. However, the results section is largely 222

qualitative, with no objective measures reported (such as POP-Q or Baden-Walker 223

exams postoperatively). 224

Lowenstein et al.’s case series [48] reported outcomes and complications 225

following abdominal uterosacral suspension (AUSS) for the treatment of pelvic 226

organ prolapse. At 1-year follow up, they found a 12% rate of subjective 227

symptomatic recurrence of prolapse, and a 7% rate of objective anatomic failure. In 228

Page 11: AAGL Practice Guidelines on the Prevention of Apical ... · 1 AAGL Practice Guidelines on the Prevention of Apical Prolapse at the Time of ... 136 vault during abdominal hysterectomy

11

this series, there was a 9% suture erosion rate with the use of permanent (GoreTex) 229

sutures. 230

We identified two long-term outcome studies evaluating high uterosacral 231

ligament suspension. Doumouchtsis’ case series [49] evaluated the long-term 232

outcomes in 42 women who had uterosacral ligament suspension performed at the 233

time of vaginal hysterectomy for prolapse, with a mean follow-up time of 59 234

months. At follow-up, 85% had no prolapse; 15% had grade 1 vault prolapse. Two 235

patients (5%) underwent surgery to treat postoperative vaginal vault prolapse. Silva 236

et al. [50] evaluated 5-year anatomic and functional outcomes following high 237

uterosacral ligament suspension. In this study, the rate of symptomatic apical 238

recurrent prolapse was 1%. An additional 4.5% of these patients underwent a 239

second surgery to treat anterior and/or posterior compartment prolapse. 240

241

Procedures that attach the vagina to pelvic ligaments 242

Sacrospinous ligament fixation 243

Sederl first described the technique of attaching the vagina to the 244

sacrospinous ligament in 1958. It was later modified and made popular in the 245

United States by Randall and Nichols [51]. There are no studies to date evaluating 246

the efficacy of the sacrospinous ligament suspension technique at the time of 247

hysterectomy (in those without prolapse) for prevention of future prolapse. 248

There are no RCTs assessing the efficacy of the sacrospinous ligament 249

fixation for the treatment of uterovaginal and/or vaginal vault prolapse [52-55]. 250

Meta-analyses of prospective (from 52-55) and retrospective (from 52-55) studies 251

Page 12: AAGL Practice Guidelines on the Prevention of Apical ... · 1 AAGL Practice Guidelines on the Prevention of Apical Prolapse at the Time of ... 136 vault during abdominal hysterectomy

12

report an anatomic or ‘objective’ failure rate from 3-37% [56-57]. Failure rates were 252

higher in the anterior compartment than in the posterior and apical compartments 253

and dependent on definition of prolapse recurrence (using Grade 1 vs Grade 2 as 254

criteria) (Morgan ref). Beer and Kuhn compiled complication events of 1922 women 255

reported in articles indexed in Medline from 1972 to 2002. It showed that most 256

common complications were that of febrile morbidity (fever or abscess) in 4.1% and 257

hemorrhage and transfusion in 1.9%. Damage to femoral, perineal and sciatic nerves 258

were reported in 1.8% and gluteal and bladder pain in 2%. 259

260

Procedures that attach the vagina to the anterior longitudinal ligament 261

There are no studies that assess this procedure for the prevention of apical 262

vaginal prolapse. 263

Sacrocolpopexy, a procedure that attaches the vaginal apex to the anterior 264

longitudinal ligament of the sacrum using permanent mesh, is generally considered 265

the gold standard for treatment of post-hysterectomy prolapse. The success rate is 266

reported to be between 78-100% when defined as lack of apical prolapse 267

postoperatively, and between 58-100% when defined as no postoperative prolapse 268

[58]. In a study of women with cervical or vaginal vault prolapse participants were 269

randomized to a vaginal repair (with bilateral sacrospinous vault suspension and 270

paravaginal repair) or an abdominal sacrocolpopexy (with paravaginal repair). 271

With a mean follow up period of 2.5 years, the relative risk of unsatisfactory 272

outcome with the vaginal route was 2.11 (95%, CI 0.9-4.9) [59] and reoperation rate 273

Page 13: AAGL Practice Guidelines on the Prevention of Apical ... · 1 AAGL Practice Guidelines on the Prevention of Apical Prolapse at the Time of ... 136 vault during abdominal hysterectomy

13

for recurrence of prolapse was greater in the vaginal compared to the abdominal 274

group (33% vs 16%). 275

A study of women with vaginal vault prolapse randomized to laparoscopic 276

sacrocolpopexy or total vaginal mesh surgery, the total objective success rate was 277

significantly greater for laparoscopic sacrocolpopexy compared to vaginal mesh 278

when evaluated by blinded nonsurgical reviewers at 2-years (77% vs 43%, p< .001.) 279

Reoperation rate for recurrence of prolapse and/or mesh complications was 280

significantly higher in the vaginal mesh group compared to those randomized to 281

laparoscopic sacrocolpopexy (22% vs 5%, p=.006) [60]. 282

In comparing minimally invasive approaches to sacrocolpopexy, a 283

randomized trial reported that while both robotic and laparoscopic groups 284

demonstrated similar vaginal support and functional outcomes at 1 year, the robotic 285

approach was associated with longer operative time (67 min difference; p<.001) 286

and greater post-operative pain at rest and activity compared to the laparoscopic 287

group [61] . Sacrocolpopexy is not used for prolapse prevention and there are no 288

current studies evaluating its use for prophylaxis. 289

290

Summary of Recommendations 291

1. McCall’s culdoplasty may be performed at the time of vaginal hysterectomy 292

for non-prolapse related disease to reduce the risk of postoperative apical 293

prolapse for up to 3 years (Level B). 294

Page 14: AAGL Practice Guidelines on the Prevention of Apical ... · 1 AAGL Practice Guidelines on the Prevention of Apical Prolapse at the Time of ... 136 vault during abdominal hysterectomy

14

2. Uterosacral ligament suspension may be performed at the time of abdominal 295

(Level B) and laparoscopic (Level C) hysterectomy to reduce the risk of post-296

hysterectomy vaginal vault prolapse. 297

3. Sacrospinous ligament fixation and abdominal sacral colpopexy are not 298

recommended for the prevention of prolapse at the time of hysterectomy for 299

non-prolapse related disease. (Level C). 300

301

Recommendations for future research 302

Available data guiding gynecologic surgeons about management of the 303

vaginal vault for the prevention of post-hysterectomy prolapse are limited. 304

Randomized trials comparing apical support procedures performed at the time of 305

hysterectomy for non-prolapse related disease are urgently needed since both 306

hysterectomy and vaginal vault prolapse are common. Specifically, a randomized 307

trial comparing McCall’s culdoplasty (with uterosacral ligament plication) to 308

uterosacral ligament suspension (without plication) is important, since both 309

procedures are accessible to the non-urogynecologic surgeon. 310

311

Page 15: AAGL Practice Guidelines on the Prevention of Apical ... · 1 AAGL Practice Guidelines on the Prevention of Apical Prolapse at the Time of ... 136 vault during abdominal hysterectomy

15

References 312

1. Jacoby VL, Autry A, Jacobson G, Domush R, Nakagawa S, Jacoby A. Nationwide 313 use of laparoscopic hysterectomy compared with abdominal and vaginal 314 approaches. Obstet Gynecol 2009;114:1041-8.(Evidene Class III) 315 2. Wilcox LS, Koonin LM, Pokras R, Strauss LT, Xia Z, Peterson HB. 316 Hysterectomy in the United States, 1988-1990. Obstet Gynecol 1994;83:549-55. 317 (Evidence Class III) 318 3. Aigmueller T, Dungl A, Hinterholzer S, Geiss I, Riss P. An estimation of the 319 frequency of surgery for posthysterectomy vault prolapse. Int Urogynecol J 320 2010;21:299-302. (Evidence Class II-3) 321 4. Altman D, Falconer C, Cnattingius S, Granath F. Pelvic organ prolapse surgery 322 following hysterectomy on benign indications. Am J Obstet Gynecol 2008;198:572 323 e1-6. (Evidence Class II-2 ) 324 5. Blandon RE, Bharucha AE, Melton LJ, 3rd, et al. Incidence of pelvic floor 325 repair after hysterectomy: A population-based cohort study. Am J Obstet Gynecol 326 2007;197:664 e1-7. (Evidence Class II-2) 327 6. Mant J, Painter R, Vessey M. Epidemiology of genital prolapse: observations 328 from the Oxford Family Planning Association Study. Br J Obstet Gynaecol 329 1997;104:579-85. (Evidence Class II-2) 330 7. Bradley CS, Zimmerman MB, Wang Q, Nygaard IE. Vaginal descent and pelvic 331 floor symptoms in postmenopausal women: a longitudinal study. Obstet Gynecol 332 2008;111:1148-53. (Evidence Class II-1 ) 333 8. Sung VW, Washington B, Raker CA. Costs of ambulatory care related to 334 female pelvic floor disorders in the United States. Am J Obstet Gynecol 335 2010;202:483 e1-4. (Evidence Class III ) 336 9. Subak L L, Waetjen L E, van den Eeden S, Thom D H, Vittinghoff E , Brown J S . 337 Cost of pelvic organ prolapse surgery in the United States. Obstet Gynecol. 2001 338 Oct;98(4):646-51. 339 10. Boyles SH, Weber AM, Meyn L. Procedures for pelvic organ prolapse in the 340 United States, 1979-1997. Am J Obstet Gynecol 2003;188:108-15. (Class III) 341 11. Brown JS, Waetjen LE, Subak LL, Thom DH, Van den Eeden S, Vittinghoff E. 342 Pelvic organ prolapse surgery in the United States, 1997. Am J Obstet Gynecol 343 2002;186:712-6. (Evidence Class III) 344 12. Luber KM, Boero S, Choe JY. The demographics of pelvic floor disorders: 345 current observations and future projections. Am J Obstet Gynecol 2001;184:1496-346 501; discussion 501-3. (Evidence Class II-2) 347 13. Wu JM, Hundley AF, Fulton RG, Myers ER. Forecasting the prevalence of 348 pelvic floor disorders in U.S. Women: 2010 to 2050. Obstet Gynecol 2009;114:1278-349 83. (Evidence Class III) 350 14. Rortveit G, Brown JS, Thom DH, Van Den Eeden SK, Creasman JM, Subak LL. 351 Symptomatic pelvic organ prolapse: prevalence and risk factors in a population-352 based, racially diverse cohort. Obstet Gynecol 2007;109:1396-403. (Evidence Class 353 II-2 ) 354

Page 16: AAGL Practice Guidelines on the Prevention of Apical ... · 1 AAGL Practice Guidelines on the Prevention of Apical Prolapse at the Time of ... 136 vault during abdominal hysterectomy

16

15. Tegerstedt G, Maehle-Schmidt M, Nyren O, Hammarstrom M. Prevalence of 355 symptomatic pelvic organ prolapse in a Swedish population. Int Urogynecol J Pelvic 356 Floor Dysfunct 2005;16:497-503. (Evidence Class II-2 ) 357 16. Jones KA, Shepherd JP, Oliphant SS, Wang L, Bunker CH, Lowder JL. Trends in 358 inpatient prolapse procedures in the United States, 1979-2006. Am J Obstet Gynecol 359 2010;202:501 e1-7. (Evidence Class III) 360 17. Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of 361 surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol 362 1997;89:501-6. (Evidence Class II-2) 363 18. Rhoads KF, Sokol ER. Variation in the quality of surgical care for uterovaginal 364 prolapse. Med Care 2011;49:46-51. (Evidence Class II-2 ) 365 19. Learman LA, Summitt RL, Jr., Varner RE, et al. A randomized comparison of 366 total or supracervical hysterectomy: surgical complications and clinical outcomes. 367 Obstet Gynecol 2003;102:453-62. (Evidence Class I) 368 20. Thakar R, Ayers S, Clarkson P, Stanton S, Manyonda I. Outcomes after total 369 versus subtotal abdominal hysterectomy. N Engl J Med 2002;347:1318-25. 370 (Evidence Class I) 371 21. Miedel A, Tegerstedt G, Maehle-Schmidt M, Nyren O, Hammarstrom M. 372 Symptoms and pelvic support defects in specific compartments. Obstet Gynecol 373 2008;112:851-8. (Evidence Class II-3) 374 22. DeLancey JO. Anatomic aspects of vaginal eversion after hysterectomy. Am J 375 Obstet Gynecol 1992;166:1717-24; discussion 24-8. (Evidence Class III) 376 23. Larson KA, Luo J, Guire KE, Chen L, Ashton-Miller JA, DeLancey JO. 3D 377 analysis of cystoceles using magnetic resonance imaging assessing midline, 378 paravaginal, and apical defects. Int Urogynecol J 2012;23:285-93. (Evidence Class II-379 3) 380 24. Rooney K, Kenton K, Mueller ER, FitzGerald MP, Brubaker L. Advanced 381 anterior vaginal wall prolapse is highly correlated with apical prolapse. Am J Obstet 382 Gynecol 2006;195:1837-40. (Evidence Class II-3) 383 25. Lowder JL, Park AJ, Ellison R, et al. The role of apical vaginal support in the 384 appearance of anterior and posterior vaginal prolapse. Obstet Gynecol 385 2008;111:152-7. (Evidence Class II-3) 386 26. Tulikangas PK, Walters MD, Brainard JA, Weber AM. Enterocele: is there a 387 histologic defect? Obstet Gynecol 2001;98:634-7. (Evidence Class II-2) 388 27. Kenton K, Shott S, Brubaker L. Vaginal topography does not correlate well 389 with visceral position in women with pelvic organ prolapse. Int Urogynecol J Pelvic 390 Floor Dysfunct 1997;8:336-9. (Evidence Class II-3) 391 28. Richardson E. A simplified technique for abdominal panhysterectomy. Surg 392 Gynecol Obstet 1929;48:248-52. (Evidence Class III) 393 29. McCall ML. Posterior culdeplasty; surgical correction of enterocele during 394 vaginal hysterectomy; a preliminary report. Obstet Gynecol 1957;10:595-602. 395 (Evidence Class III) 396 30. Lee RA, Symmonds RE. Surgical repair of posthysterectomy vault prolapse. 397 Am J Obstet Gynecol 1972;112:953-6. (Evidence Class III) 398

Page 17: AAGL Practice Guidelines on the Prevention of Apical ... · 1 AAGL Practice Guidelines on the Prevention of Apical Prolapse at the Time of ... 136 vault during abdominal hysterectomy

17

31. Symmonds RE, Williams TJ, Lee RA, Webb MJ. Posthysterectomy enterocele 399 and vaginal vault prolapse. Am J Obstet Gynecol 1981;140:852-9. (Evidence Class 400 III) 401 32. Ostrzenski A. A new, simplified posterior culdoplasty and vaginal vault 402 suspension during abdominal hysterectomy. Int J Gynaecol Obstet 1995;49:25-34. 403 (Evidence Class II-3) 404 33. Wall LL. A technique for modified McCall culdeplasty at the time of 405 abdominal hysterectomy. J Am Coll Surg 1994;178:507-9. (Evidence Class III) 406 34. Carter JE, Winter M, Mendehlsohn S, Saye W, Richardson AC. Vaginal vault 407 suspension and enterocele repair by Richardson-Saye laparoscopic technique: 408 description of training technique and results. JSLS 2001;5:29-36. (Evidence Class III) 409 35. Lin LL, Phelps JY, Liu CY. Laparoscopic vaginal vault suspension using 410 uterosacral ligaments: a review of 133 cases. J Minim Invasive Gynecol 411 2005;12:216-20. (Evidence Class II-3) 412 36. Miklos JR, Kohli N, Lucente V, Saye WB. Site-specific fascial defects in the 413 diagnosis and surgical management of enterocele. Am J Obstet Gynecol 414 1998;179:1418-22; discussion 822-3. (Evidence Class II-3) 415 37. Ostrzenski A. Laparoscopic colposuspension for total vaginal prolapse. Int J 416 Gynaecol Obstet 1996;55:147-52. (Evidence Class II-3) 417 38. Seman EI, Cook JR, O'Shea RT. Two-year experience with laparoscopic pelvic 418 floor repair. J Am Assoc Gynecol Laparosc 2003;10:38-45. (Evidence Class II-2) 419 39. Rahn DD, Marker AC, Corton MM, et al. Does supracervical hysterectomy 420 provide more support to the vaginal apex than total abdominal hysterectomy? Am J 421 Obstet Gynecol 2007;197:650 e1-4. (Evidence Class III) 422 40. Rahn DD, Stone RJ, Vu AK, White AB, Wai CY. Abdominal hysterectomy with 423 or without angle stitch: correlation with subsequent vaginal vault prolapse. Am J 424 Obstet Gynecol 2008;199:669 e1-4. (Evidence Class III) 425 41. Cruikshank SH, Kovac SR. Randomized comparison of three surgical methods 426 used at the time of vaginal hysterectomy to prevent posterior enterocele. Am J 427 Obstet Gynecol 1999;180:859-65. (Evidence Class I) 428 42. Colombo M, Milani R. Sacrospinous ligament fixation and modified McCall 429 culdoplasty during vaginal hysterectomy for advanced uterovaginal prolapse. Am J 430 Obstet Gynecol 1998;179:13-20. (Evidence Class II-2) 431 43. Cruikshank SH. Preventing posthysterectomy vaginal vault prolapse and 432 enterocele during vaginal hysterectomy. Am J Obstet Gynecol 1987;156:1433-40. 433 (Evidence Class II-3) 434 44. Chene G, Tardieu AS, Savary D, et al. Anatomical and functional results of 435 McCall culdoplasty in the prevention of enteroceles and vaginal vault prolapse after 436 vaginal hysterectomy. Int J Urogynecol J Pelvic Floor Dysfunct 2008;19:1007-11. 437 (Evidence Class II-3) 438 45. Given FT, Jr. "Posterior culdeplasty": revisited. Am J Obstet Gynecol 439 1985;153:135-9. (Evidence Class II-3 ) 440 46. Hoffman MS, Lynch CM, Nackley A. Ureteral obstruction from high McCall's 441 culdeplasty. J Gynecol Surg 2000;16:119-23. (Evidence Class II-3 ) 442

Page 18: AAGL Practice Guidelines on the Prevention of Apical ... · 1 AAGL Practice Guidelines on the Prevention of Apical Prolapse at the Time of ... 136 vault during abdominal hysterectomy

18

47. Rardin CR, Erekson EA, Sung VW, Ward RM, Myers DL. Uterosacral colpopexy 443 at the time of vaginal hysterectomy: comparison of laparoscopic and vaginal 444 approaches. J Reprod Med 2009;54:273-80. (Evidence Class II-2 ) 445 48. Lowenstein L, Fitz A, Kenton K, FitzGerald MP, Mueller ER, Brubaker L. 446 Transabdominal uterosacral suspension: outcomes and complications. Am J Obstet 447 Gynecol 2009;200:656.e1-.e5. (Evidence Class III) 448 49. Doumouchtsis SK, Khunda A, Jeffery ST, et al. Long-term outcomes of 449 modified high uterosacral ligament vault suspension (HUSLS) at vaginal 450 hysterectomy. Int Urogynecol J 2011;22:577-84. (Evidence Class II-3) 451 50. Silva WA, Pauls RN, Segal JL, Rooney CM, Kleeman SD, Karram MM. 452 Uterosacral ligament vault suspension - Five-year outcomes. Obstet Gynecol 453 2006;108:255-63. (Evidence Class II-3) 454 51. Randall CL, Nichols DH. Surgical treatment of vaginal inversion. Obstet 455 Gynecol 1971;38:327-32. (Evidence Class III) 456 52. Hefni MA, El-Toukhy TA. Sacrospinous colpopexy at vaginal hysterectomy: 457 method, results and follow up in 75 patients. J Obstet Gynaecol 2000;20:58-62. 458 (Evidence Class II-3) 459 53. Hoffman MS, Harris MS, Bouis PJ. Sacrospinous colpopexy in the management 460 of uterovaginal prolapse. J Reprod Med 1996;41:299-303. (Evidence Class II-3) 461 54. Meschia M, Bruschi F, Amicarelli F, Pifarotti P, Marchini M, Crosignani PG. 462 The sacrospinous vaginal vault suspension: Critical analysis of outcomes. Int 463 Urogynecol J Pelvic Floor Dysfunct 1999;10:155-9. (Evidence Class III) ? 464 55. Silva-Filho AL, Triginelli SA, Santos-Filho AS, Candido EB, Traiman P, Cunha-465 Melo JR. Sacrospinous fixation for treatment of vault prolapse and at the time of 466 vaginal hysterectomy for marked uterovaginal prolapse. Female Pelvic Medicine & 467 Reconstructive Surgery 2004;10:213-18. (Evidence Class II-3) 468 56. Beer M, Kuhn A. Surgical techniques for vault prolapse: a review of the 469 literature. Eur J Obstet Gynecol Reprod Biol 2005;119:144-55. (Evidence Class II-3) 470 57. Morgan DM, Rogers MA, Huebner M, Wei JT, Delancey JO. Heterogeneity in 471 anatomic outcome of sacrospinous ligament fixation for prolapse: a systematic 472 review. Obstet Gynecol 2007;109:1424-33. (Evidence Class II-3 ) 473 58. Nygaard IE, McCreery R, Brubaker L, et al. Abdominal sacrocolpopexy: a 474 comprehensive review. Obstet Gynecol 2004;104:805-23. (Class II-3) 475 59. Benson JT, Lucente V, McClellan E. Vaginal versus abdominal reconstructive 476 surgery for the treatment of pelvic support defects: A prospective randomized study 477 with long-term outcome evaluation. AJOG 1996;175:1418-22. (Evidence Class I) 478 60. Maher CF, Feiner B, DeCuyper EM, Nichlos CJ, Hickey KV, O’Rourke PO. 479 Laparoscopic sacral colpopexy versus total vaginal mesh for vaginal vault prolapse: 480 a randomized trial. AJOG 2011; 204:360. (Evidence Class 1) 481 61. Paraiso MFR, Jelovsek JE, Frick A, Chen CCG, Barber MD. Laparoscopic 482 compared with robotic sacrocolpopexy for vaginal prolapse. (Evidence Class I). 483 484

Page 19: AAGL Practice Guidelines on the Prevention of Apical ... · 1 AAGL Practice Guidelines on the Prevention of Apical Prolapse at the Time of ... 136 vault during abdominal hysterectomy

19

Studies were reviewed and evaluated for quality according to the method outlined by the US 485 Preventive Services Task Force. 486 487 Class I Evidence obtained from at least 1 properly designed randomized controlled trial. 488 489 Class II Evidence obtained from nonrandomized clinical evaluation. 490 491

II-1 Evidence obtained from well-designed controlled trials without randomization. 492 II-2 Evidence obtained from well-designed cohort or case-control analytic studies, 493 preferably from more than 1 center or research center. 494 II-3 Evidence obtained from multiple time series with or without the intervention. 495 Dramatic results in uncontrolled experiments also could be regarded as this type of 496 evidence. 497

Class III Opinions of respected authorities, based on clinical experience, descriptive studies, or 498 reports of expert committees. 499 500 Based on the highest level of evidence found in the data, recommendations are provided and 501 graded according to the following categories: 502

Level A—Recommendations are based on good and consistent scientific evidence. 503

Level B—Recommendations are based on limited or inconsistent scientific evidence. 504

Level C—Recommendations are based primarily on consensus and expert opinion. 505

506

Acknowledgement 507

This report was developed under the direction of the Practice Committee of 508 the AAGL as a service to their members and other practicing clinicians. 509

The members of the AAGL Practice Committee have reported the following 510 financial interest or affiliation with corporations: Jason A. Abbott, PhD, FRANZCOG, 511 Hologic—Consultant, Speakers Bureau; Krisztina I. Bajzak, MD, FRCSC, MSc, Nothing 512 to disclose; Isabel C. Green, M.D., Nothing to disclose; Volker R. Jacobs, MD, PhD, 513 MBA, Nothing to disclose. Neil P. Johnson, M.D., CREI, FRANZCOG, FRCOG, MRCGP, 514 Nothing to disclose; Marit Lieng, MD, PhD, Nothing to disclose; Malcolm G. Munro, 515 M.D., Abbott Laboratories—Consultant, Aegea Medical—Consultant, Stock 516 Ownership, Baxter—Consultant, Bayer Healthcare Corp.—Consultant, Boston 517 Scientific Corp. Inc.—Consultant, channel Medical—Consultant, Stock Ownership, 518 Conceptus Incorporated—Consultant, CooperSurgical—Consultant, EndoSee 519 Corp.—Consultant, Ethicon Women’s Health & Urology—Consultant, Femasys—520 Consultant, Gynesonics—Consultant, Stock Ownership, Halt Medical—Consultant, 521 Stock Ownership, Hologic—Consultant, Idoman Teoranta—Consultant, Karl Storz 522 Endoscopy—Consultant; Sony Sukhbir Singh, BSc, M.D., FRCSC, Abbott 523 Laboratories—Consultant, Grants/Research, Speakers Bureau, Bayer Healthcare 524 Corp.—Consultant, Speakers Bureau, Ethicon Endo-Surgery—Speakers Bureau, 525 Minerva Surgical—Grants/Research, Covidien—Speakers Bureau; Eric R. Sokol, 526

Page 20: AAGL Practice Guidelines on the Prevention of Apical ... · 1 AAGL Practice Guidelines on the Prevention of Apical Prolapse at the Time of ... 136 vault during abdominal hysterectomy

20

M.D., American Medical Systems—Consultant, Pelvalon—Stock Ownership, 527 Contura—Grants/Research. 528

The members of the AAGL Guideline Development Committee for the 529 Prevention of Apical Prolapse at the Time of Benign Hysterectomy have reported 530 the following financial interest or affiliation with corporations: Andrew I. Sokol, 531 M.D.,—Nothing to disclose. Rosanne Kho, MD.,—Nothing to disclose. Rebecca U. 532 Margulies, M.D.,—Nothing to disclose. Charles R. Rardin, M.D.,—Nothing to disclose. 533 Eric R. Sokol, M.D., American Medical Systems—Consultant, Pelvalon—Stock 534 Ownership, Contura—Grants/Research. 535

Acknowledgement: We would like to thank Ms. Eliane Purchase, Library Assistant at 536 Mayo Clinic-Arizona for her assistance with the literature search. 537

538