One-year follow-up after laparoscopic hysteropexy and vaginal hysterectomy: a randomised study.

P. Rahmanou, N. Price, S. Jackson,

The Department of Urogynaecology, John Radcliffe Hospital, Oxford, UK

Introduction: •  A prior observational prospective study has shown

laparoscopic hysteropexy is an effective operation for uterine prolapse1. We now report 1 year follow up data from a randomised study comparing laparoscopic hysteropexy with vaginal hysterectomy for uterine prolapse.

Methods: •  132 women were recruited from clinic with symptomatic

uterine prolapse requesting surgery. Enrolment methodology is demonstrated in Figure 1.

•  Women were randomised to vaginal hysterectomy (VH) or laparoscopic hysteropexy (LH) (Figure 2). As this is a first randomised study, no power calculation was available.

•  In women undergoing VH 98% had concomitant pelvic floor repair, whereas 82% in LH group. Those with stage 4 prolapse had sacrospinous fixation with VH.

•  Subjects were reviewed 1-year post surgery. •  Operation data, complications, recovery time, pelvic organ

prolapse quantification (POP-Q)2 anatomical outcomes, International Consultation on Incontinence questionnaire for vaginal symptoms (ICIQ-VS)3 for functional and quality of life outcomes and repeat prolapse surgery within 1 year were measured.

•  Wilcoxon sign rank and Mann-Whitney tests were used to compare pre-operative with post-operative data and difference between the two groups, respectively.

Results: •  1-year follow-up data was obtained for 37 women in LH

group and 35 women in VH group following deduction of those who had repeat apical surgery.

•  Data summarised in the tables below. •  The return to normal activity, the blood loss and hospital

stay was significantly less in the hysteropexy group.

Conclusions: •  Laparoscopic hysteropexy and vaginal hysterectomy both

result in significant objective and subjective improvement at 12 months.

•  There was no statistically sig difference in ICIQ-VS changes between the 2 operations, but both had significant reduction in scores.

•  Hysteropexy was associated with better apical support; point C and total vaginal length are significantly improved and there is less chance of repeat apical surgery. However, more vaginal repair required post hysteropexy operation.

•  Laparoscopic hysteropexy is a safe surgical alternative to vaginal hysterectomy but longer follow-up data from larger studies are required.

References: 1)Price, N., et al. Laparoscopic hysteropexy: the initial results of a uterine suspension procedure for uterovaginal prolapse. BJOG, 2010. 117(1): p. 62-8. 2) Bump, R.C., et al., The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol, 1996. 175(1): p. 10-7. 3) Price, N., et al., Development and psychometric evaluation of the ICIQ Vaginal Symptoms Questionnaire: the ICIQ-VS. BJOG, 2006. 113(6): p. 700-12.

A B

D E F

C

Figure 2. The surgical technique of laparoscopic hysteropexy. (A) Opening of the left broad ligament. (B) Mesh inserted through windows in the broad ligament. (C) Suturing of the mesh over the anterior cervix. (D) Closure of the uterovesical peritoneum. (E) Peritonisation of the mesh prior to fixation to the sacral promontory. (F) Mesh in place and peritonisation complete.

Table 1. Demographic (No significant difference between the two groups)

Table 2.. Repeat Prolapse operation post initial surgery.

Oxford University Hospitals NHS Trust

132 recruited

50 Vaginal Hysterectomy (VH)

39 Completed 1 year follow up

50 Laparoscopic Hysteropexy (LH)

40 Completed 1 year follow up

1 converted from LH to VH

31 declined Randomisation

Figure 1. The enrolment diagram.

LH (n=50) VH(n=50) Age (mean+/- SD) 64 +/- 7.5 65+/- 8.4

BMI (mean+/- SD) 26.0 +/- 3.6 27.5 +/- 4.2

Parity [Median (range)] 2 (1-5) 2 (1-6)

Compartments Prolapse operations LH (n=50)

VH (n=50)

Apical Lap. Sacrocolpopexy _ 4(+3)

Cervical Amputation 1 _ Lap. Plication of Mesh 2 _

Anterior Anterior Repair (+2) 0

Posterior Posterior Repair 0 0

Both Anterior& Posterior Repair 2(+1) 0

Laparoscopic hysteropexy Vaginal hysterectomy

p value Pre-op (n=50)

Post-op (p=37)

Mean differen

ce (p=37)

Pre-op (n=50)

Post-op (p=35)

Mean differen

ce (p=35)

ICIQ-VS VS Score 34.7 8.9 -27.5 33.3 7.3 -24 0.448 SM Score 27.8 13.2 -18.5 28.8 11.1 -16.3 0.329

QOL 7.2 2.2 -5.4 7.8 1.3 -6.1 0.154 POP-Q

Ba 1.7 -0.8 -2.2 0.9 -0.6 -1.2 0.063 C 2.9 -5.4 -6.8 1.9 -4.3 -5 <0.001 Bp 0.5 -2.7 -2.4 0.6 -2.4 -2.4 0.666

TVL 8.4 8.4 -1.2 8.2 6.5 -3.2 <0.001

(In bracket)= Booked for surgery after review Table 3. POP-Q & ICIQ-VS scoring pre- and post-operation and comparing mean difference between the groups.