evidence-based clinical practice guidelines on the ...evidence-based clinical practice guidelines on...

PJSSiilll'ilTil?iii"ry''3iEvidence-Based Clinical Practice Guidelines on the Management of Adult Inguinal

Hernia: Primary Inguinal Hernia, Recurrent Inguinal Hernia and Bi lateral Inguinal

Hernia

Nilo C. de los Santoso M.D., F.P.C.S.; Ray I. Sarmientoo M.D., 'F.P'C'S'; Mari lou N' Agno' M'D.l

F.P.C.S.; Dakila P. de los Angeles, M.D., F.P.C.S.; Domingo A. Bongala, M'D'o F'P'C'S'; Joseph D'

Quebralo M.D., F.P.C.S. and Jose Antonio M. Salud, M.t, F.P.C.S.; for the Phil ippine Society of

General Surgeons Inc.

PJSS Vol.62, No. l, January-March,2007

This information, based on the Phi l ippine Society of

Genera l Surgeons (PSGS) lnc . C l in ica l Prac t ice

Guidel ines. is intended to assist physicians and pat ients

in the management of adult inguinal hernias' A dist inct

panel of experts together with the Technical Working

Group (TWG) developed the PSGS Cl inical Pract ice

Guidel ines. These guidel ines are given by the PSGS

based on the current scientific evidence and its views

concerning accepted approaches to treatment of adult

inguinal hernias.These guidelines are not proposed to change, but to

assist the prof ic iency and cl in ical judgment of physicians

on the management of pat ients with adult inguinal

hernia. Eaclr pat ient 's condit ion must be evaluated

ind iv idua l l y . I t i s impor tan t to d iscuss the gu ide l ines

and all information regardingtreatment options with tlie

pat ient. The choice of a wel l - informed pat ient plays a

great ro le in the dec is ion-mak ing o f the surg ica l

procedure.

Execut ive Summary

The Phi l ippine Society of General Surgeons (PSGS)

Inc. together with the Phi l ippine Col lege of Surgeons

(PCS) has publ ished i ts Evidence-based Cl inical Pract ice

Guidel ines (EBCPG) on other important general surgical

condit ions. From then on, numerous high qual i ty cl in ical

tr ia ls have been publ ished on di f ferent general surgical

p r o b l e m s . T h e s e p u b l i c a t i o n s h a v e r e s u l t e d i n

rnodif icat ions in other cl in ical pract ice guidel ines, l ike

those in the United Statesand Europe'

In the Phi l ippines, inguinal hernia repair is one of

the most common surgical procedures performed by

general surgeons and the number is expected to continue

io rise in the future' The country's economic development

and the rapid westernization of our lifestyles are major

factors expected to contribute to the increased awareness

of this condit ion.The TWG put in order the cl in ical quest ions' search

m e t h o d , l e v e l s o f e v i d e n c e , a n d c a t e g o r i e s o f

recommendat ions ' The TWG has been regu la r ly

monitor ing the major sources of publ icat ions, namely'

the Pubmed (Medl ine) of the U'S' Nat ional Library of

Medicine and The Cochrane Library'

Level of Eviddnce

I. Evidence from at least one properly designed

i.randomized control led tr ia l or meta-analysis '

l l . Evidence from at least one wel l designed cl inical

trial without proper randomization, from prospective

or cohort or case-control analytic studies (preferably

from one center), f rom mult iple t ime-series studies'

or from dramatic results in uncontrolled experiments'

I l l . Evidence from opinions of respected authori t ies on

the basis ofcl in ical experiences, descr ipt ive studies'

or reports of exPert committees'

Categories of Recommendation

Category A: At least 7Soh consensus by expert panel

present

40

EBCPGs on the Management of Adul t Inguinal Hernia

C a t e g o r y B : R e c o m m e n d a t i o n w a s s o m e w h a tcontroversial and did not meet consensus

Category C: Recommendation caused real disagreementsamong panel

The TWG prepared the first draft of the manuscriptwhich consisted of a summary of the strongest evidenceassociated with the clinical questions and suggested therecommendations. The first draft was discussed andmodified by a Panel of Experts called together by thePSGS on August 3,2005 atthe Lubang Room of EDSAShangrila Hotel. A second draft was completed by theTWG and this was discussed in a Publ ic Forum onDecember 7,2005 duringthe 63'd PCS Cl inical Congressheld at the Kamia Room of EDSA Shangri la Hotel . ThePSGS Board of Directors then accepted the guidelineson February 11,2006.

Summary of Recommendations :

L The recommended treatment for inguinal hernia ismesh repair, either the laparoscopic or the openmethod. (Level 1A, Category A)

2. Therecommendedtechniques for laparoscopicmeshrepair are transabdominal preperitoneal (TAPP) ortotal extra preperitoneal (TePP) repair. (Level 1B,Category A)

3. It is not necessaryto fixthe mesh during laparoscopicTAPP or TEPP inguinal hernia repair . (Level 1B,Category A)

4. The recommended techniques for open mesh repairare the Lichtenstein, Plug and mesh and the ProleneHernia System. (Level lB, Category A)

5. The recommended treatment for recurrent inguinalhernia is mesh repair , ei ther the laparoscopic or theopen method. (Level 1A, Category A)

6. The recommended treatment for bilateral inguinalhernia is mesh repair , ei ther the laparoscopic or theopen method. (Level 1A, Category A)

7. Ant imicrobia l prophylax is is not rout ine lyrecommended for elective groin hernia repair usingmesh. (Level lA, Category A)

Technical Working Group

Members:Ray I. Sarmiento, M.D., F.P.C.S. (Chair)Mari lou N. Agno, M.D., F.P.C.S.Domingo A. Bongala, M.D., F.P.C.S.Dakila P. de los Angeles, M.D., F.P.C.S.Joseph D. Quebral, M.D., F.P.C.S.Jose Antonio M. Salud, M.D., F.P.C.S.Nilo C. de los Santos, M.D., F.P.C.S. (Director)

Panel ofExperts:

l . Reynaldo M. Baclig, M.D., F.P.C.S.(Cebu Eastern Visayas Chapter)

2. Raymond G. Casipit, M.D., F.P.C.S.(Central Luzon Chapter)

3. Dominador M. Chiong Jr., M.D., F.P.C.S.(Metro Manila Chapter)

4. Giovanni A. Delos Reyes, M.D., F.P.C.S.(Panay Chapter)

5. Romeo G. Ehcanto, M.D., F.P.C.S.(Metro Manila Chapter)

6. Ramon S. Inso, M.D., F.P.C.S.(S out hern Tagal o g C hapt er)

7. Jaime B. Lagunil la, M.D., F.P.C.S.(Northern Mindanao Chapter)

8. Arturo E. Mendoza, M.D., F.P.C.S.(Central Luzon Chapter)

9. Wil l iam L. Olal ia, M.D., F.P.C.S.(Metro Manila Chapter)

10. Rey Melchor F. Santos, M.D., F.P.C.S.(Metro Manila Chapter)

I 1 . Jesus V. Valencia, M.D. , F.P.C.S.(Metro Manila Chapter)

4 l

PJSS Vof.62, No. l, January-March,200742

Acknowledgment

Johnson and Jolrnson, Phi l ippines supportedthis project

o f the Ph i l ipp ine Soc ie ty o f Genera l Surgeons, lnc . The

sponsoring company in no way inf luenced the outcome

of these gu ide l ines .

Methods

The TWG used combined MESH terms and free text

searches of databases from PubMed, Cochrane Library

and the Ph i l ipp ine Journa l o f Surg ica l Spec ia l t ies

(PJSS) to re t r ieve t i t les . On ly re levant t i t les were

selected for ful l - text retr ieval by norninal group

technique and appraised by the group for el ig ibi l i ty of

t l re retr ieved studies. A total of 252 journal t i t les were

retr ieved, 13 ful l textt i t les were used forthe guidel ines.

The Levels of Evidence used was based on the Oxford

C e n t r e f o r E v i d e n c e - B a s e d M e d i c i n e L e v e l s o f

E v i d e n c e . M a y 2 0 0 1 .Outcome measures used in these Guidel ines were

hernia recurrence as the primary outcome and duration

of operation (rninutes), hematoma, seroma, wound/

superf ic ial infect ion, ser ious compl icat ions (rnesh/deep

infect ion. vascular injury, v isceral in jury), length of

postoperative hospital stay (days), time to return to

normal act iv i t ies, pain persist ing at least > 3 months,

and numbness at least > 3 montl ls, as the secondary

outcornes.

Operat ional Def i ni t ions

I . Persist ing pain was def ined as groin pain of any

severi ty ( inclLrding test icular) persist ing at one year

after the operation, or at the closest time point to one

year provided this was at least three months after

sLrrgery.

2 . P e r s i s t i n g n u m b n e s s i n c l u d e d p a r e s t h e s i a ,

dysesthesia and discomfort persist ing at one year

after the operation, or at the closest time pointto one

year provided this was at least three months after

sLlrgery.

Hernia recurrence data were based on the methods

of ascertainment used in individualtr ia ls ' Mean or

median duration of follow-r-rp ranged from 6 weeks

to 36 months.

Adult-Age of participants greater or equal to l6

years. Subjects' ages ranged from 1 6-85 years

(med ian o f 52 .3) .

T A P P ( t r a n s a b d o m i n a l p r e p e r i t o n e a l ) a

laparoscopic hernia technique in whiclr the peritoneal

cavity is traversed and an incision is made over tlre

peritoneum to expose the preperitoneal space over

ihe inguinal area for mesl i on lay placement ' The

peri toneum is then approximated (with staples or

sutur ing) to cover the mesh prosthesis '

TEPP/TePP/TEP (total ly extraperi toneal) - a

l a p a r o s c o p i c a p p r o a c h w h e r e i n t h e r e i s n o

penetration into the peritoneal cavity' The working

space is preperitoneal and is created by inflating a

balloon or by blunt dissection into the preperitoneal

space to expose the inguinal area. The mesh is

placed on lay into the preperitoneal space'

IPOM - intraperi toneal on lay mesh repair is a

laparoscop ic techn ique where a compos i te mesh

is placecl to cover the hernia defect without

d i s s e c t i o n o f t h e p r e p e r i t o n e a l s p a c e ' T h e

mesh is anchored to the abdominal cavi ty over the

per i toneum.

'Lichtenstein repair (LR)/open on-lay/open flat mesh

- a mesh trimmed to fit the inguinal floor and

secured by sutures.

Mesh plug repair (MPR)/plug and mesh - a two part

mesh prosthesis, one as a plug (sutured) and one as

flat mesh anterior to it (unsutured)'

3 .

Aa .

5 .

6 .

7 .

8 .

9 .

10. Prolene Hernia System (PHS) - c ircular mesh and a

flat mesh that is connected by a tubular mesh acting

as one unit where the flat portion is placed anterior,

the tubular portion into the inguinal canal and the

c i r c u l a r p o r t i o n i s p l a c e d p o s t e r i o r t o t h e

transversalis fascia or preperitoneally'


Results

1. What is the recommended treatment for inguinalhernia?

The recommended treatment for inguinal hernia is rneshrepair , the laparoscopic orthe open method. (Level I A,Category A)

McCormack K, Scott NW, Go PMNYH and Ross S(EU Hernia Tr ial ists Col laborat ion) in 2003r reviewedlaparoscopic techniques versus open techniques foringu ina l hern ia repa i r . Th is was pub l ished in theCochrane Database of Systematic Reviews 2003. This

is a meta-analysis of forty-one randomized control t r ia ls( R C T s ) i n v o l v i n g 7 1 6 1 p a r t i c i p a n t s c o m p a r i n glaparoscopic techniques versus open techniques foringuinalhernia repair . The outcome showsthe fol lowing:operation times for laparoscopic repair were longer,there was a higher r isk of rare ser ious compl icat ions inlaparoscopic repair, return to usual activities was fasterin laparoscopic repair, less persisting pain and numbnessin laparoscopic repair , hernia recurrence was lesscommon in laparoscopic repair than open non-meshrepair but not different to open mesh methods and areduced recurrence ofaround 30-50 percent was relatedto the use of mesh rather than the method of meslrplacement.

43

Comparison of Clinical Outcomes of Laparoscopic versus Open Techniques for Inguinal Hernia Repair

Outcome No. of Studies No. of Participants Statistical Method Effect Size

Duration of operation(minutes)Vascular injuryVisceral injuryTime to return tousual activities (days)Persisting painPersisting numbnessHernia recurrence

J I

zo22

648252564914

260845003043oo4z

Weighted Mean Difference (Fixed) 95% CIPeto Odds Ratio 95% CIPeto Odds Ratio 95% CI

Peto Odds Ratio 95% CIPeto Odds Ratio 95% CIPeto Odds Ratio 95% CIPeto Odds Ratio 95% CI

14.81 [13.98, 15 64]|.38 [0.44,4.29]s . 7 6 l r . s 3 , 2 r . 6 8 1

0.s6 [0.s 1, 0.61]0.54 [0.46, 0.6410.38 [0.29, 0.49]0 .81 [0 .61 , 1 .08 ]

202 l1 639

Source: Scott NW, McCormack K, Graham P, Go PMNYH, Ross SJ, Grant AM on behalf d the EU Hernia Trialists Collaboration.Laparoscopic techniques vs. open techniques for inguinal hernia repair. The Cochrane Database ofSystematic Reviews, 2005, Issue 2

2. lf laparoscopic mesh repair is the preferredtechn ique fo r ingu ina l hern ias , what i s therecommended laparoscopic technique?

The recommended techniques for laparoscopic meshrepair are transabdominal preperitoneal (TAPP) or totalextra preperitoneal (TePP). (Level lB, Category A)

Schrenk P, Woisetschlaged R, Rieger R, and WayanW2 in November 1996 publ ished in the Bri t ish Journalof Surgery a prospective randomized trial comparingtransabdominal preperitoneal, total preperitoneal orShouldice technique for inguinal hernia repair on the

rate of postoperative pain and return to physical activity.A total of 86 patients were randomized in the study,Shouldice (n:34), TAPP (n=28) or TPP (n=24), Resultsshowed that there was no significant difference betweentlre three groups for postoperative pain and return tophysical act iv i ty.

Leopoldo Sarli, et al.3 in December 1997 published inthe Journal of Surgery Laparoscopy and Endoscopy aprospective comparison ofTAPP and IPOMtechniques, inlaparoscopic hernia repair alnong I l5 patients. Meanfollow-up of patients was 32 months after the IPOMprocedure and a mean follow-up of 28 months, after the

44 PJSS Vol. 62, No. 1, January-March' 2007

Weight Peto ORo/o 95olo Cl

Studyor sub<ategory

Treatment Controln/N n/N

r / 4 22 / 5 27 / 5 Ao / a o7 / 9 43 / 6 2o / 2 so / 5 Lo / 2 02 / I I Or / 2 ao / 1 51 / 4 86 / 4 2a / 1 14 / r 3 8o / 2 4r / s E

3 / 20'7o / 5 4

r / 3 4

o / 5 0r / 2 0 01 1 1 3

Total ewnts: 53 (Treatment), 71 (Control)Test for hatorogeneity: Chiz = 37.31, df = 20 (P = O.01 )' 12 = 46.40/oTest for o\,€rall elfect. Z = 1 .1 I (P = 0.23)

Hernia Recurrence Comparing Laparoscopic versus Open Techniques for Inguinal Hernia Repairs.

Peto OR95% cl

01 TAPP Ecus OpenAarberg 1 996Adelaide 1994Ancona 1998Bangkok 1998Berlin 1996Bie t ighe im 1998Bydgoszcz 1998Caen 1998Hawaii '1994

Kokkola 1997Linkopin 1 997Linz 1 996MRCmulticentre 1999Maastricht 1998Maastricht 1999Michigan l99TNyborg 1 999Omaha 1996Oxford 1995Parma 1997scuR l999Stuttgart 1995Tampere 1998Toumai 1996utm 1993Whipps Cross 1994Whipps Cross 1998

Subtotal (95o/o Cl)

6 / 4 9o / 4 4o / 5 6a / 5 ' 7o / 1 6 03 / r a o

o / 3 0o / 4 9o / r as / 8 9o / 3 ao / ' 7 6

22 / A '7

3 / 1 3 02 / 2 9a / 6 6l / s 6

t 1 / 4 4 6o / 4 8t / J !

3 / 3 3o / 2 12 / 4 4L / 2 0 0: 1 3 6

4 . 6 3

1 . 1 t -

2 . A A2 - 7 1

3 . ' 7 6

3 . 6 0

3 . 9 6

1 . 0 9

9 . ' 7 0

3 . 0 6

2 . 1 40 - 5 5

1 . 1 1

0 . 5 6z 5 . a d

0 . 5 6

3 . 8 ?

2 . L 1

4 . 8 41 . 1 0

3 8 . 6 9

0 . 4 6 [ 0 . 1 2 , L . 8 r )? . ? 5 t 0 . 1 5 , 3 9 O . 9 6 18 . 1 4 t o - 5 0 , 1 3 2 . O 6 11 - 2 6 L A - L 4 , 3 6 6 . O ' 7 1

N o t e s t i m a b l eo - 6 6 [ 0 . 0 8 , 5 . 2 5 ]3 . 3 1 t 0 . a 5 , 2 4 . 2 0 )

N o t e s t i m a b l eNot es t imab l -eN o t e s t i m a b l e

0 . 3 3 f 0 . o ' 7 , r . 4 9 19 . 1 5 t 0 . 1 8 , 4 6 9 . 9 8 1

N o t e s t i m a b l e0 . 2 9 t 0 - 1 3 , 0 . 6 4 14 . t 2 l a . 8 8 , 1 9 . 3 2 12 . ' 1 1 t A - 6 2 , L r . a 4 lL - 2 6 l O . 2 A , 5 . 6 A l0 . 1 6 [ 0 . 0 1 . 2 . 5 8 ]8 . 4 8 t 0 . 7 1 , 4 3 0 . 9 1 12 . 1 3 l o - 2 2 , 2 0 - 9 5 1o . 4 2 1 o . 1 6 , 1 . 0 8 1

N o t e s t i m a b l e4 . 8 3 [ 0 . 9 0 , 2 5 . 4 L )0 . 3 4 ( 0 . 0 5 , 2 . s 3 )6 - 1 6 I 0 . L 2 , 3 L 6 . 6 1 10 . 1 3 t 0 . o L , 2 . 0 6 11 . 0 0 t 0 . 0 6 , 1 6 . 0 4 1o . E 0 t r l . 5 5 / i . . l - 6 1

02 TEP ve.sus OpenBrisbane 1996Coala Trial Gp 1997Denizli 1998Hawaii 1996Linz 1996MRCmulticentre 1999Madrid 1997Ou lu 21998Paris 1994Paris 1997Quebec 1998Woodville 1996subrotal (950/0 cl)

L / 9 2t't / a8'7

o /32r / 5 0a / 2 41 /285o / 5 90 / 2 20 / 8 93 / 5 r3/7312 / 4 1:t.3i Ii

0 / 9231/ 5o'7

0 / 3 20 /500 / 3 40 / 2 1 10/5 ' lo / 2 30 / 9 2L / 4 96/ I I60 / 5 51 .3 r 8

7 . 3 9 I 0 . 1 s , 3 1 2 . 3 8 10 . 5 ? [ 0 . 3 2 , 1 . 0 1 ]

Not est imable? . 3 9 t 0 . L 5 , 3 7 2 . 3 8 1

Not est imable1 . L 9 t L . 6 2 , 3 r . 8 9 1

Not est imableNot est imableNot estimable

2 . 6 9 1 0 . 3 1 , 7 9 . 1 L )0 . 4 2 t 0 . 1 1 , 1 . 5 9 18 . 9 5 f 0 . 5 5 , L 4 6 . 3 ' 7 )0 . 8 9 [ 0 . 5 6 , 1 . . 4 3 ]

Total e\ents: 34 (Treatment), 38 (Control)Test for heterogeneity: Chi'z = 17.16, dt = 6 (P = 0.009), 12 = 65.0oloTest for orerall etled: Z= 0.47 (P = 0.64)

03 Miscellaneous Laparoscopic rersus OpenSubtotal (95% Cl) 0 0Total events: 0 (Treatment), 0 (Control)Test for heterogeneity: not applicableTest for overall effect: not applicable

t, loL esLimabl.j

Total (95% Cl) : j 1 4 8 3 5 0 4

Total e\ents: 87 (Treatment), 109 (Control)Test for heterogeneity: Chi2 = 54.61, dl = 27 (P = 0.001), 12 = 50.60/oTest for o\Erall effect: z = 1.22 (P -- o.22\

0.001 0.01 0.1 1 10 100 1000

Favcurs treatment Fa\ curs control

Source: Scott NW, McCormack K, Graham P, Go PMNYH, Ross SJ, Grant AM on behalf of the EU Hernia Trialists

Collaboration. Laparoscopic techniques vs. open techniques for inguinal hernia repair. The Cochrane Database of

Systematic Reviews, 2005, Issue 2

1 r ) 0 . 0 0

EBCPGs on the Management o f Adu l t Ingu ina l Hern ia

TAPP procedure. Results showed that neuralgias occurredin 3 TAPP and 1 I cases of IPOMp < 0.05 and recurrencesoccurred in no cases of TAPP and in 8 cases of IPOM( p 5 0 . 0 1 ) .

3. Is fixation of the mesh necessary in laparoscopicrepair?

I t is not necessary to secure the mesh duringlaparoscopic TAPP or TEPP inguinal hernia repair.(Level 1 B, Category A)

Moreno-Egea, et al.a in December 2004 publishedin the Archives of Surgery a randomized clinical trial offixation vs. nonfixation of mesh in total extraperitonealinguinal hernioplasty. A total of 170 patients wereassigned and followed-up for 36 +12 months. Resultsshowed that there were no significant differences withregard to operating time, morbidity or recurrences(p < .001 ) .

Smith AI, et al.5 in 1999 published in the Journal ofSurgical Endoscopy a prospective randomized trialcompar ing s tapled and nonstapled laparoscopictransabdominal preperitoneal (TAPP) inguinal herniarepair. A total of 502 patients were randomized: 263were nonstapled and 273 were stapled repairs. Patientswere fol lowed-up for a median of 16 months. Results

Comparison of Flat Mesh vs. Plug and Mesh.

showed that there was no statistical difference in theincidence of recurrence: 0 in 263 nonstapled patientsand 3 in 273 stapled patients chi-square (p : 0.09).Similarly, there was no significant difference in operativetime, port-site hernia, chronic pain or neuralgia betweenthe two groups.

4. I f open mesh repairo what is the recommendedtechnique?

The recommended technique for open mesh repairis the Lichtenstein, plug and mesh or Prolene HerniaSystem. (Level 1B, Category A)

Scott NW, McCormack, Graham P, Go PMNYH,Ross SJ, and Grant AM6 on behalf of the EU HerniaTrialistCollaboratiorr in 2005 published in The CochraneCollaboration a review on open rnesh versus non meshrepair for groin hernia. The aim of the review was toevaluate mesh techniques in the open surgical repair ofgroin hernias. The open flat mesh (Lichtenstein) repairwas compared with plug and rnesh (plug and patch)repair. Results showed that there was insufficierrt datato reliably address different types of open mesh repair,particularly flat mesh and plug and mesh repair but itseemed that there was no significant difference betweenthe two techniques.

45

Outcome Title Number of Studies No. of Participants Statistical Method Effect Size

Duration of operation (mins) 2

Hematoma 2

Seroma 2Wound/superficial infection 2

Length ofstay (days) I

Time to return to usual activities 2Pain 0Numbness 0Recurrence 2

220

1 1 1

221221141

2t400

214

Weighted Mean Difference(Fixed) 95% CI

Peto Odds Ratio 95% CI








4.4s U..6s,7.2s)

1.04 [0.06, 16.s8]1.00 [0.06, 16.27]3.s3 [0.60,20.62]-0.07 [-0.21, 0.07]

1.09 [0.83,r.42]Not estimable

Not estimable

0 .14 [0 .01 ,1 .32 ]

Source: Scott NW, McCormack K, Graham P, Go PMNYH, Ross SJ, Grant AM on behalf of the EU Hernia Trialists Collaboration.Laparoscopic techniques vs. open techniques for inguinal hernia repair. The Cochrane Database ofSystematic Reviews, 2005, Issue 2

46

Niejhuijs SW, Van Oort I , Keemers-Gels ME,Strobbe LJA and Rosman C.7 in January 2005 publishedin the Brit ish Journal of Surgery a randomized cl inicaltr ial comparing the Prolene Hernia System (PHS),mesh plug repair (MPR) and Lichtenstein method foropen inguinal hernia repair. A total of 334 patientswere a l located b l ind ly , 11 I to PHS, 113 to MPR andI l0 to Lichtenstein. The aim was to compare the 3techniques of open mesh repair. Short and long termresu l t s (2 weeks , 3 mon ths and a t 15 mon thspostoperative fol low up) were determined. Outcomeswere postoperative pain and quali ty of l i fe. Resultsshowed that pat ients repor ted no d i f ference inpostoperative pain in the three types of herniarepair inthe 1" l4 days and mean amount of paracetamol usedper day was 1.9, 1.6 and l.8 grn after PHS, MPR andLichtenstein repair, respectively. In conclusion, therewas no clinically significant difference in post operativepain and quali ty of l i fe among the three types of meshhernia repair.

PJSS Vof. 62, No. l, January-March,2007

5 . W h a t i s t h e r e c o m m e n d e d t r e a t m e n t f o r

recurrent inguinal hernia?

The recommended treatment for recurrent inguinal

hernia is mesh repair, either laparoscopic or open method'

(Level I A, Category A)

Mc Cormack K, Scott NW, Go PMNYH, Ross S,

and Grant AMr on behalf of the EU Hernia Trialists

Col laborat ion publ ished in 2003 in The Cochrane

Database of Systematic Reviews a study comparing

laparoscopic repair versus open repair for recurrent

hernias. Twelve RCTs were included and subgroup

analysis on recurrent hernias was conducted' Results

showed the fol lowing: durat ion of operat ion was

sighif icant ly longer for laparoscopic approach but

hematoma, visceral in jury, persist ing pain, persist ing

numbness, seroma, and wound/superficial infection,

hernia recurrence were all comparable. Length of stay

in the hospital was significantly shorter for laparoscopic

approach and time to return to usual activities was

signifi cantly faster for laparoscopic approach'

Comparison of Laparoscopic vs. Open Repair for Recurrent Hernias

Outcome Title No. of Studies No. of Participants Statistical Method Effect Size

Duration of the operation (minutes) 14 448

Hematoma l i 383

Seroma 11 379

Wound/superficial infection 11 383

Mesh/deep infection 9 358

Vascular injury 10 312

Visceral injury 9 306

Length ofstay (days) 12 367

Time to return to usual activities (days) 11 262

Persisting pain 9 331

Persisting numbness 9 332

Hernia recurrence t2








Weighted Mean Difference(Fixed) 95o/o CI


Peto Odds Ration 95% CI


Peto odds Ratio 95% CI

r4.3r 110.77,r7.851

0.60 [0.34,1.06]

| .39 l0 .67 ,2.901

0 .50 [0 .17 ,1 .46 ]

0.22 [0.00,13.54]

Not estimable

5.47 10.10,293.681

0.0r [ -0.13,0.15]

0.60 [0.46,0.78]

0.90 [0.50,1.s9]

0.79 [0.39,1.61]

1.04t0.45,2.431

Source: McCormack K, Scott NW, Go PMNYH, Ross S (EU Hernia Trialists Collaboration) The Cochrane Database of Systemattc

Reviews 2003, Laparoscopic techniques versus open techniques for inguinal hernia repair (Review)


Comparison of Laparoscopic vs. Open Repair for Recurrent Hernias and Time to Return to Usual Activities (days).

47

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Source: McCormack K, Scott NW, Go PMNYH, Ross S (EU Hernia Trialists Collaboration) The Cochrane Database ofSystematic Reviews 2003, Laparoscopic techniques versus open techniques for inguinal hernia repair (Review).

Comparison of Laparoscopic Techniques vs. Open Techniques in Recurrent Inguinal Hernia Repair and Recurrence.

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t , . 0 ! 1 1 f l a r 0 . 1

fe \ : . i ru rs t r * *mEd fa?$ 'J r$ . , t r j f i t .d l

Source: McCormack K, Scott NW, Go PMNYH, Ross S @U Hernia Trialists Collaboration) The Cochrane Database ofSystematic Reviews 2003, Laparoscopic techniques versus open techniques for inguinal hernia repair @eview)

48

6. What is the recommended treatment for bilateralinguinal hernia?

The recommended treatment for bi lateral inguinalhernia is mesh repair , ei ther laparoscopic or open.(Level l , Category A)

ScottNW, McCormack K, Graham P, Go PMNYH,

Ross SJ, and Grant AM8 on behalf of the EU Hernia

Trial ists Col laborat ion publ ished in 2005 a study on

laparoscopic techniques vs. open techniques for inguinal

hernia repair . Twelve RCTs were included and subgroup

analysis of bi lateral hernias was done. No signi f icant

di f ferences in recurrence rate. incidence of hematoma,seroma. length of hospital stay, persist ing pain and

n u m b n e s s b e t w e e n l a p a r o s c o p i c a n d o p e n m e s h

procedures were found. Laparoscopic mesh procedures

had a longer durat ion of operat ion, at td seemed to have

a h i g h e r i n c i d e n c e o f v i s c e r a l i n j u r y . L i k e w i s e ,

laparoscopic mesh procedures had sl ight ly less wound/

superf ic ial infect ion and shorter t ime to returtr to usual

ac t iv i t ies .Mahon D, Decadt B and Rhodes Me in 2003

pub l ished in the Journa l o f Surg ica l Endoscopy a

Comparison of Laparoscopic vs, Open (Bilateral Hernias)

PJSS Vol.62, No. 1, January-March,2007

p r o s p e c t i v e r a n d o m i z e d t r i a l o f l a p a r o s c o p i c

(transabdominal preperitoneal) vs open (mesh) repair

for bilateral and recurrent inguinal hernia. A total of 1 20

patients with bilateral or recurrent hernias, 42 recurrent

and 70 bilateral. Seven were both bilateral and recurrent'

Pr imary outcome was postoperat ive pain and the

secondary outcomes: wel l -being, post-op mobi l izat ion,

return to work. recurrence rate, chronic pain and

complicat ions. Results showed that there was no

difference in terms ofrecurrence, incidence of hematoma

and other compl icat ions.

Comparison of Laparoscopic Techniques vs. Open Mesh Techniques

in Bilateral Inguinal Hernia Repair and Hernia Recurrence'

(+) Recurrence (-) Recurrence

LaparoscopicOpen

p = 0.351 NS

Estimate 9s%cr

5559

A

I

RRIARINNH

3.0680 .051

20.000

-0.s32,34.332-0 .021 to 0 .1238 t o 4 8

No. of Studies No. of Participants Statistical Method Effect SizeOutcome title

Duration of the operation (minutes)

Hematoma

Seroma

Wound/ superfi cial infection\ / ^ ^ ^ , , 1 ^ - ; - ; , , - , .v 4 ) L U r 4 r l r u u r j

Viscerai injury

Length ofstay (days)

Time to retum to usual activities (days)

Persisting pain

Persisting numbness

Hernia recurrence

A

1 1

1 0

1 1

8

9

1 3

r 1

78

t 2

168

266

250

265

185

232

292

2t '7223

228

227









Peto Odds Ration 95% CI


Peto odds Ratio 95% CI

12 . r217 .98 , r6 .26J

1.38 [0.67,2.83]1.2410.s6,2.7 s)

0 .27 [0 .10 ,0 ,75 ]Not estimable

5 .16 [0.09 ,286 .571-0 .09 [0 .19 ,0 .01 ]

0.s9 [0.44,0.1e10.70 [0.38,1.30]0 .56 [0 .24 ,1 .31 ]o1 .36 [0 . s5 ,3 .37 ]

Source: Scott NW, McCormack, Graham P, Go PMNYH, Ross SJ, Grant AM on behalf of the EU Hernia Trialist Collaboration Open

mesh versus non mesh for groin hernia repair @eview) The Cochrane Collaboration The Cochrane Ltbrary 2005, Issue 2


Comparison of Laparoscopic Techniques vs. Open Techniques in Bilateral Inguinal Hernia Repair.

49

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Source: Scott NW, McCormack, Graham P, Go PMNYH, Ross SJ, Grant AM on behalf of the EU Hernia Trialist Collaboration Open meshversus non mesh for groin hernia repair (Review) The Cochrane Collaboration The Cochrane Library 2005, Issue 2.

Comparison of Laparoscopic Techniques vs. Open Techniques in Bilateral Inguinal Hernia Repair and Hernia Recurrence.

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Source: Scott NW, McCormack, Graham P, Go PMNYH, Ross SJ, Grant AM on behalf of the EU Hernia Trialist Collaboration Open meshversus non mesh for groin hernia repair (Review) The Cochrane Collaboration The Cochrane Llorary 2005, Issue 2

50

Sarl i L, Iusco DR, Sansebastiano C, Costi Ra in2001 published in the Journal of Surgery Laparoscopyand Endoscopy a prospective randomized study of opentension-free versus laparoscopic approach in the repairof bi lateral inguinal hernias. A total of 43 low riskpatients were randomized with a blind envelope system,single surgeon with adequate experience in laparoscopicp repe r i t onea l "b i k in i mesh" (TAPP) vs . openLichtenstein hernioplasty. There was no difference inoperating t ime, 95 +l- 32.3 min vs. 99 +l- 28.3 min, nointraoperative complications for both, the intensity ofpostoperative pain was greater in the ogen group at 24hours, 48 hours and 7 days after surgery (p = 0.001 ) witha greater consumption of pain medication among thesepatients (p<0.05). Only I asymptomatic recurrence(43%) was discovered in the open group.

Median (25th-75th percentile) Visual Analog Scale for Pain forLaparoscopic vs Open Herniorrhaphy.

Time point Laparoscopic (n=20) Open (n=23)

PJSS Vol.62, No. l, January-ll larch' 2007

hernia. The aim was to determine whether systemic

antibiotic prophylaxis prevented wound infection after

repair of abdominal wall hernia with rnesh. The incidence

of infection after groin hernia repair was 3 8 (3.0 %) of

1277 inthe placebo group and l8 ( l -5 %) of 1230 in the

ant ibiot ic group. Ant ibiot ic prophylaxis did not

significantly reduce the incidence of infection: odds

rat io 0.54 (95 %CI0.24to I .21); number needed to treat

was 7 4. The number of deep infections was six (0 '6 %)

in the placebo group and three (0'3 %) in the antibiotic

prophylaxis group: odds rat io 0.50 (95 Yo Cl 0.12 to

2.09). Ant ibiot ic prophylaxis did not prevent the

occurrence ofwound infection after groin hernia surgery'

Comparisons ofProphylactic Antibiotic vs. Placebo in Mesh Repairsin Abdominal Wall Hernia Repair and Wound Infection'

Prophylaxis Placebo OR (95% CI)

zs* not significant

Source: Sarli L, Iusco DR, Sansebastiano G, Costi R. SimultaneousRepair of Bilateral Inguinal Hernias: A Prospective, RandomizedStudy ofOpen, Tension-Free versus Laparoscopic Approach. SurgLaparosc Endosc Percutan Tech 2001. l l(4):262-267.

7. Is antimicrobial prophylaxis recommended for

elective groin hernia surgery?

An t im i c rob ia l p rophy lax i s i s no t r ou t i ne l yrecommended for elective groin hernia surgery usingmesh. (Level I A, Category A)

Aufenacker TJ, Koelemay MJW, Gouma DJ andSimons MPr0 in 2005 published in the Brit ish Journal ofSurgery a systematic review and meta-analysis of theeffectiveness of antibiotic prophylaxis in prevention ofwound infection after mesh repair of abdominal wall

Superficial infectionDeeo infections

NNT = 74

Source: Aufenacker, T. J, Koelemay, M.J'W, Gouma, D'J, and

Simons, M.P. Sys temat ic rev iew and meta-ana lys is o f the

effectiveness of antibiotic prophylaxis in prevention o[ wound

infection after mesh repair of abdominal wall hernia. Br J Surg 2005;

9 3 : 5 - 1 0

i

Sanchez-Manuel FJ and Seco-Gil JL' l in 2004reviewed antibiotic prophylaxis for hernia repair. Thiswa's.published in the Cochrane Database of SystematicReviews in June 2004. The objective of this systematicreview was to clarify the effectiveness of antibioticprophylaxis in reducing postoperative wound infectionrates in elective open inguinal hernia repair. Eightrandomized clinical trials were identified. Three of

them used prosthet ic mater ia l for hern ia repai r(hernioplasty) whereas the remaining studies did not(herniorraphy). Pooled and subgroup analysis wereconducted depending on whether prosthetic materialwas used or not.'The total number of patients included

wasZg0T (treatment group: 142 l, control group: I 486)'

Overall infection rates were 2.88 percentand4 '3 percent

in the prophylaxis and control groups, respectively

t8/12303/ 1230

38/1277 0.s4 (0.24, r.2l)7/1277 o.50 (0.12, 2.09)

Preoperative6 hrs post-op12 hrs24hrs48 hrs

| (1-2)3 (2-s)3 (2-4)1 (1 -3 )I ( 1 -3 )

1 (1 -2 )4 (2-6)4 (2-6)4 (2-6)3 (2-s)

ns* 'ns*ns*0 .0010.00 I


(OR0.65,95%Cl0.35 - I .21). (The subgroup of patientswith herniorrhaphy had infection rates of 3.78 percentand 4.87 percent in the prophylaxis and control groups,respectively(OR0.84,95%U 0.53 - L34). The subgroupof patients with hernioplasty had infection rates of 1.2percent and 3.3 percent in the prophylaxis and controlgroups, respectively (OR 0.28, 95%U 0.02 - 3.14).Based on the results of this meta-analysis, there was noclear evidence that routine administration of antibiot icprophylaxis for elective inguinal hernia repair reducedinfection rates.

Comparisons ofProphylacticAntibioticvs. Placebo in Open InguinalHernia Repair and Wound Infection.

Prophylaxis (%) Control (%) OR (95% CI)

Schrenk P, Woisetschlaged R, Rieger R, Wayan W. Prospectiverandomized trial comparing postoperative pain and return to physicalactivity after transabdominal preperitoneal, total preperitoneal orShouldice technique for inguinal hernia repair, Br J Surg 1996;8 3 ( l l ) : 1 5 6 3 - 1 5 6 6 .Sarl i L, Iusco DR, Sansebastiano G. Costi R. Simultaneous repair ofbi lateral inguinal hernias: A prospective, randornized study ofopen,tension-free versus laparoscopic approach. Surg Laparosc EndoscPercutan Tech 200 I : 1 1 (4): 262-267 .Moreno-Egea, et al. Randonrized cl inical tr ial of f ixat ion vs.nonfixation of mesh in total extraperitoneal inguinal hernioplasty.Arch Surg 2004;139 (12): 1376-1379.Smith AI, et al. Stapled and nonstapled laparoscopic transabdominalpreperitoneal (TAPP) inguinal hernia repair. A prospective randomizedtr ial. Surg Endosc 1999; l3(8): 804-806.Scott NW, McCormack, Graham P, Go PMNYH, Ross SJ, Grant AMon behalfofthe EU Hernia Trial ist Collaboration Open nreslt versusnon mesh for groin hernia repair (Review) The Cochrane CollaborationThe Cochrane Library 2005, Issue 2.Niejhui js SW, van Oort I , Keemers-Gels ME, Strobbe LJA, Rosman C.Randomized cl inical tr ial comparing the Prolene Hernia System,mesh plug repair and Lichtenstein method for open inguinal herniarepa i r . Br J Surg 2005: 92 ( l ) : 33-38 .Scott NW, McCormack K, Graham P, Go PMNYH, Ross SJ, GrantAM on behalfofthe EU Hernia Trial ists Collaboration. Laparoscopictechniques vs. open techniques for inguinal hernia repai r. The CochraneDatabase of Systematic Reviews, 2005, tssue 2.Mahon D, Decadt B, Rhodes M. Prospective randomized tr ial oflaparosoopic (transabdominal preperitoneal) vs. open (mesh) repairfor bi lateral and recurrent inguinal hernia. Surg Endosc 2003; l7:r 386-1390,Aufenacker TJ, Koelemay MJW, Gouma DJ and Simons MP.Systematic review and meta-analysis of the effectiveness of antibioticprophylaxis in prevention of wound infection after mesh repair ofabdominal wall hernia. Br J Surg 2005; 93: 5-l 0.Sanchez-Manuel FJ and Seco-Gil JL. Antibiot ic prophylai is forhernia repair (Review) The Cochrane Collaboration The CochraneLibrarv 2004. lssue 1.

5 l

3 .

o .

0verallinfection rate 41/1421 (2.88) 64/1486 (4.3)

Herniorrhaphy 35/924 (3.78) 46/943 (4.87)

Herniopiasty 5/373 (t.2) t8/420 (3.3)

0,65 (0 .35 , 1 .21)

0.84 (0.s3, 1.34)

0.28 (0.02,3.r4)

Source: Sanchez-Manuel FJ and Seco-Gil JL. Antibiotic Prophylaxisfor hernia repair (Review) The Cochrane Collaboration TheCochrane Library 2004, Issue I

References

l . McCormack K, Scott NW, Co PMNYH, Ross S (EU Hernia Trial istsCollaboration). Laparosoopic techniques versus open techniques foringuinal hernia repair (Review). The Cochrane Database ofSystematicReviews 2003; 5-6, 43-46.

9 .

l 0

l l

evidence-based clinical practice guidelines on the ...evidence-based clinical practice guidelines on...

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