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Hernia
Published in: Hernia 2/2017

01-04-2017 | Review

Prophylactic mesh to prevent parastomal hernia after end colostomy: a meta-analysis and trial sequential analysis

Authors: M. López-Cano, H.-T. Brandsma, K. Bury, B. Hansson, I. Kyle-Leinhase, J. G. Alamino, F. Muysoms

Published in: Hernia | Issue 2/2017

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Abstract

Purpose

Prevention of parastomal hernia (PSH) formation is crucial, given the high prevalence and difficulties in the surgical repair of PSH. To investigate the effect of a preventive mesh in PSH formation after an end colostomy, we aimed to meta-analyze all relevant randomized controlled trials (RCTs).

Methods

We searched five databases. For each trial, we extracted risk ratios (RRs) of the effects of mesh or no mesh. The primary outcome was incidence of PSH with a minimum follow-up of 12 months with a clinical and/or computed tomography diagnosis. RRs were combined using the random-effect model (Mantel–Haenszel). To control the risk of type I error, we performed a trial sequential analysis (TSA).

Results

Seven RCTs with low risk of bias (451 patients) were included. Meta-analysis for primary outcome showed a significant reduction of the incidence of PSH using a mesh (RR 0.43, 95% CI 0.26–0.71; P = 0.0009). Regarding TSA calculation for the primary outcome, the accrued information size (451) was 187.1% of the estimated required information size (RIS) (241). Wound infection showed no statistical differences between groups (RR 0.77, 95% CI 0.39–1.54; P = 0.46). PSH repair rate showed a significant reduction in the mesh group (RR 0.28 (95% CI 0.10–0.78; P = 0.01).

Conclusions

PSH prevention with mesh when creating an end colostomy reduces the incidence of PSH, the risk for subsequent PSH repair and does not increase wound infections. TSA shows that the RIS is reached for the primary outcome. Additional RCTs in the previous context are not needed.
Literature
1.
2.
Pilgrim CH, McIntyre R, Bailey M (2010) Prospective audit of parastomal hernia: prevalence and associated comorbidities. Dis Colon Rectum 53:71–76CrossRefPubMed
3.
4.
Robertson I, Leung E, Hughes D et al (2005) Prospective analysis of stoma-related complications. Colorectal Dis 7:279–285CrossRefPubMed
5.
Arumugam PJ, Bevan L, Macdonald L et al (2003) A prospective audit of stomas–analysis of risk factors and complications and their management. Colorectal Dis 5:49–52CrossRefPubMed
6.
Kald A, Juul KN, Hjortsvang H, Sjodahl RI (2008) Quality of life is impaired in patients with peristomal bulging of a sigmoid colostomy. Scand J Gastroenterol 43:627–633CrossRefPubMed
7.
8.
9.
De Raet J, Delvaux G, Haentjens P, Van Nieuwenhove Y (2008) Waist circumference is an independent risk factor for the development of parastomal hernia after permanent colostomy. Dis Colon Rectum 51:1806–1809CrossRefPubMed
10.
Hansson BM, Slater NJ, van der Velden AS et al (2012) Surgical techniques for parastomal hernia repair: a systematic review of the literature. Ann Surg 255:685–695CrossRefPubMed
11.
Helgstrand F, Rosenberg J, Kehlet H et al (2013) Risk of morbidity, mortality, and recurrence after parastomal hernia repair: a nationwide study. Dis Colon Rectum 56:1265–1272CrossRefPubMed
12.
Hansson BM, Morales-Conde S, Mussack T et al (2013) The laparoscopic modified Sugarbaker technique is safe and has a low recurrence rate: a multicenter cohort study. Surg Endosc 27:494–500CrossRefPubMed
13.
Wijeyekoon SP, Gurusamy K, El-Gendy K, Chan CL (2010) Prevention of parastomal herniation with biologic/composite prosthetic mesh: a systematic review and meta-analysis of randomized controlled trials. J Am Coll Surg 211:637–645CrossRefPubMed
14.
Tam KW, Wei PL, Kuo LJ, Wu CH (2010) Systematic review of the use of a mesh to prevent parastomal hernia. World J Surg 34:2723–2729CrossRefPubMed
15.
Shabbir J, Chaudhary BN, Dawson R (2012) A systematic review on the use of prophylactic mesh during primary stoma formation to prevent parastomal hernia formation. Colorectal Dis 14:931–936CrossRefPubMed
16.
Sajid MS, Kalra L, Hutson K, Sains P (2012) Parastomal hernia as a consequence of colorectal cancer resections can prophylactically be controlled by mesh insertion at the time of primary surgery: a literature based systematic review of published trials. Minerva Chir 67:289–296PubMed
17.
Liberati A, Altman DG, Tetzlaff J et al (2009) The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. J Clin Epidemiol 62:e1–e34CrossRefPubMed
18.
Guyatt GH, Oxman AD, Vist GE et al (2008) GRADE Working Group. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 336:924–926CrossRefPubMedPubMedCentral
19.
Alonso-Coello P, Rigau D, Sanabria AJ et al (2013) Quality and strength: the GRADE system for formulating recommendations in clinical practice guidelines. Arch Bronconeumol 49:261–267CrossRefPubMed
20.
21.
DerSimonian R, Laird N (2015) Meta-analysis in clinical trials revisited. Contemp Clin Trials 45(PtA):139–145
22.
Deeks JJ, Higgins JPT, Altman DG (2008) Chapter 9: analysing data and undertaking meta-analyses. In: Higgins JPT, Green S (eds) Cochrane handbook for systematic reviews of interventions. Wiley, Chichester, pp 243–293CrossRef
23.
Bradburn MJ, Deeks JJ, Berlin JA, Russell Localio A (2007) Much ado about nothing: a comparison of the performance of meta-analytical methods with rare events. Stat Med 26:53–77CrossRefPubMed
24.
Thorlund K, Imberger G, Walsh M et al (2011) The number of patients and events required to limit the risk of overestimation of intervention effects in meta-analysis–a simulation study. PLoS One 6:e25491CrossRefPubMedPubMedCentral
25.
Brok J, Thorlund K, Gluud C, Wetterslev J (2008) Trial sequential analysis reveals insufficient information size and potentially false positive results in many meta-analyses. J Clin Epidemiol 61:763–769CrossRefPubMed
26.
Wetterslev J, Thorlund K, Brok J, Gluud C (2008) Trial sequential analysis may establish when firm evidence is reached in cumulative meta-analysis. J Clin Epidemiol 61:64–75CrossRefPubMed
27.
Thorlund K, Engstrøm J, Wetterslev J, Brok J, Imberger G, Gluud C (2011) User manual for trial sequential analysis (TSA). Copenhagen, Denmark: Copenhagen Trial Unit, Centre for Clinical Intervention Research, pp 1–115. http://​www.​ctu.​dk/​tsa
28.
Hammond TM, Huang A, Prosser K et al (2008) Parastomal hernia prevention using a novel collagen implant: a randomised controlled phase 1 study. Hernia 12:475–481CrossRefPubMed
29.
Jänes A, Cemgiz Y, Israelsson LA (2009) Preventing parastomal hernia with a prosthetic mesh: a 5-year follow-up of a randomized study. World J Surg 33:118–123CrossRefPubMed
30.
Serra-Aracil X, Bombardo-Junca J, Moreno-Matias J et al (2009) Randomized, controlled, prospective trial of the use of a mesh to prevent parastomal hernia. Ann Surg 249:583–587CrossRefPubMed
31.
López-Cano M, Lozoya-Trujillo R, Quiroga S et al (2012) Use of a prosthetic mesh to prevent parastomal hernia during laparoscopic abdominoperineal resection: a randomized controlled trial. Hernia 16:661–667CrossRefPubMed
32.
Fleshman JW, Beck DE, Hyman N et al (2014) PRISM Study Group. A prospective, multicenter, randomized, controlled study of non-cross-linked porcine acellular dermal matrix fascial sublay for parastomal reinforcement in patients undergoing surgery for permanent abdominal wall ostomies. Dis Colon Rectum 57:623–631CrossRefPubMed
33.
Târcoveanu E, Vasilescu A, Cotea E et al (2014) Parastomal hernias—clinical study of therapeutic strategies. Chirurgia (Bucur) 109:179–184
34.
Lambrecht JR, Larsen SG, Reiertsen O et al (2015) Prophylactic mesh at end-colostomy construction reduces parastomal hernia rate: a randomized trial. Colorectal Dis 17:191–197CrossRef
35.
Vierimaa M, Klintrup K, Biancari F et al (2015) Prospective, randomized study on the use of a prosthetic mesh for prevention of parastomal hernia of permanent colostomy. Dis Colon Rectum 58:943–949CrossRefPubMed
36.
López-Cano M, Serra-Aracil X, Mora L et al (2016) Preventing parastomal hernia using a modified Sugarbaker technique with composite mesh during laparoscopic abdominoperineal resection: a randomized controlled trial. Ann Surg 264(6):923–928CrossRefPubMed
37.
Brandsma H-T, Hansson BME, Aufenacker TJ et al (2016) Prophylactic mesh placement during formation of an end-colostomy reduces the rate of parastomal hernia; short term results of the Dutch PREVENT-trial. Ann Surg. doi:10.​1097/​SLA.​0000000000001903​
38.
39.
Jänes A, Weisby L, Israelsson LA (2011) Parastomal hernia: clinical and radiological definitions. Hernia 15:189–192CrossRefPubMed
40.
41.
Moreno-Matias J, Serra-Aracil X, Darnell-Martin A et al (2009) The prevalence of parastomal hernia after formation of an end colostomy. A new clinico-radiological classification. Colorectal Dis 11:173–177CrossRefPubMed
42.
Pogue J, Yusuf S (1998) Overcoming the limitations of current meta-analysis of randomised controlled trials. Lancet 351:47–52CrossRefPubMed
43.
Pogue JM, Yusuf S (1997) Cumulating evidence from randomized trials: utilizing sequential monitoring boundaries for cumulative meta-analysis. Control Clin Trials 18:580–593 (discussion 661–666)
Metadata
Title
Prophylactic mesh to prevent parastomal hernia after end colostomy: a meta-analysis and trial sequential analysis
Authors
M. López-Cano
H.-T. Brandsma
K. Bury
B. Hansson
I. Kyle-Leinhase
J. G. Alamino
F. Muysoms
Publication date
01-04-2017
Publisher
Springer Paris
Published in
Hernia / Issue 2/2017
Print ISSN: 1265-4906
Electronic ISSN: 1248-9204
DOI
https://doi.org/10.1007/s10029-016-1563-x

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