End Colostomy With or Without Mesh to Prevent a Parastomal Hernia (GRECCAR 7)

Prudhomme, Michel; Rullier, Éric; Lakkis, Zaher; Cotte, Eddy; Panís, Yves; Meunier, Brigitte; Rouanet, Philippe; Tuech, Jean‐Jacques; Jafari, Mehrdad; Portier, G.; Dubois, Anne; Sielezneff, Igor; Parc, Yann; Faucheron, Jean‐Luc; Meurette, G.; Lelong, Bernard; Piessen, Guillaume; Karoui, Mehdi; Fabbro‐Peray, Pascale; Dematteï, Christophe; Bertrand, Martin

doi:10.1097/sla.0000000000004371

Cited by 42 publications

(60 citation statements)

References 27 publications

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“…[Correction added on 05 October 2021 after first online publication: In the preceding line, >-0.97 and >-0.94 hve been corrected to >-0.95 and >-0.93 respectively in this version.] We note that three [5,34,44] of the four largest multicentre RCTs did not provide strong evidence to exclude the possibility that synthetic mesh has no effect in reducing the incidence of PSH. In contrast, the fourth RCT [2] reported a much lower rate of PSH incidence in the group who received prophylactic mesh.…”

Section: Discussionmentioning

confidence: 83%

A semi‐Markov model comparing the lifetime cost‐effectiveness of mesh prophylaxis to prevent parastomal hernia in patients undergoing end colostomy creation for rectal cancer

et al. 2021

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Aim: Parastomal hernia (PSH) is a common problem following colostomy. Using prophylactic mesh during end colostomy creation may reduce PSH incidence, but concerns exist regarding the optimal type of mesh, potential long-term complications, and costeffectiveness of its use. We evaluated the cost-effectiveness of mesh prophylaxis to prevent PSH in patients undergoing end colostomy creation for rectal cancer. Methods:We developed a decision-analytical model, stratified by rectal cancer stages I-IV, to estimate the lifetime costs, quality-adjusted life-years (QALYs) and net monetary benefits (NMBs) of synthetic, biologic and no mesh from a UK NHS perspective. We pooled the mesh-related relative risks of PSH from 13 randomised controlled trials (RCTs) and superimposed these on the baseline (no mesh) risk from a population-based cohort.Uncertainty was assessed in sensitivity analyses.Results: Synthetic mesh was less costly and more effective than biologic and no mesh to prevent PSH for all rectal cancer stages. At the willingness-to-pay threshold of £20,000/ QALY, the incremental NMBs (95% CI) ranged between £1,706 (£1,692 to £1,720) (stage I) and £684 (£678 to £690) (stage IV) for synthetic versus no mesh, and £2,038 (£1,997 to £2,079) (stage I) and £1,671 (£1,653 to £1,689) (stage IV) for synthetic versus biologic mesh. Synthetic mesh was more cost-effective than no mesh unless the relative risk of PSH was ≥0.95 for stages I-III and ≥0.93 for stage IV. [Correction added on 05 October 2021 after first online publication: The estimation of health outcomes (QALYs) for all three interventions evaluated (synthetic mesh; biologic mesh; no mesh) have been corrected in this version.] Conclusions: Synthetic mesh was the most cost-effective strategy to prevent the formation of PSH in patients after end colostomy for any rectal cancer stage; however, conclusions are dependent on which subset of RCTs are considered to provide the most robust evidence.

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Section: Discussionmentioning

confidence: 83%

A semi‐Markov model comparing the lifetime cost‐effectiveness of mesh prophylaxis to prevent parastomal hernia in patients undergoing end colostomy creation for rectal cancer

et al. 2021

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“…Excluding the RCT by Jänes et al [43] from the primary meta-analysis yielded a slightly higher RR of 0.62 (0.45-0.83) (I 2 = 58%; P < 0.01; Figure S15 in Appendix S1). Combining the two largest multicentre RCTs [5,36] with blinded outcome assessment produced an RR of 0.95 (0.73-1.25) (I 2 = 0%; P < 0.77; Figure S16 in Appendix S1), which indicates no significant difference in treatment effect between the mesh and no mesh groups.…”

Section: Sensitivity Analysesmentioning

confidence: 99%

“…In another sensitivity analysis, the RCT by Jänes et al [43] was excluded from the primary meta-analysis since it was the only RCT with a follow-up period of 60 months. In the final sensitivity analysis, the two largest RCTs [5,36] with low risk of detection bias (blinding of outcome assessment) were pooled together.…”

Section: Outcome Measuresmentioning

confidence: 99%

“…Most RCTs were deemed to be at low risk of selection (random sequence generation and allocation concealment), attrition (incomplete outcome data) and reporting (selective reporting) bias. Performance bias (blinding of participants and personnel) was unclear in most RCTs (n = 11), while it was high in one RCT [42] and low in another RCT [36]. Five RCTs [2,35,37,42,47] were assigned with high risk of detection bias (blinding of outcome assessment) and two RCTs [46,48] were graded as unclear.…”

Section: Risk-of-bias Assessmentmentioning

confidence: 99%

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Use of prophylactic mesh during initial stoma creation to prevent parastomal herniation: a systematic review and meta‐analysis of randomised controlled trials

et al. 2021

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Aim: Parastomal hernia (PSH) is a common complication following stoma creation.Previous reviews found mesh reinforcement during initial stoma creation beneficial in reducing PSH incidence. Since then, several multicentre randomised controlled trials (RCTs) produced widely ranging results rendering previous findings debatable. This current review assessed whether combining the latest larger multicentre RCTs would alter the previous findings. Methods:The Cochrane Library, MEDLINE and Embase were searched from the respective dates of inception until 15 January 2021. RCTs were included if they compared mesh with no mesh during initial stoma creation in adult patients to prevent PSH. Included RCTs were summarised narratively and meta-analysed to estimate the relative risk (RR) of PSH incidence (primary analysis), peristomal complications and PSH repair (secondary analyses). Several subgroup analyses were performed, including mesh type (synthetic/biologic), surgical technique (open/laparoscopic) and mesh position (sublay/intraperitoneal).Results: Thirteen RCTs were included in the primary meta-analysis (1070 patients); PSH incidence was reduced in patients with mesh compared with patients without mesh at maximal follow-up (RR = 0.54; 95% CI 0.39-0.77; I 2 = 67%; P < 0.01). The number of PSH repairs was fewer in patients who had mesh (RR = 0.63; 0.35-1.14; I 2 = 6%; P = 0.39), with no difference in peristomal complications (RR = 0.96; 0.55-1.70; I 2 = 0%; P = 0.71), comparing with no mesh. Subgroup analyses suggested that placing synthetic mesh using an open sublay technique might be more beneficial.Conclusions: Prophylactic mesh reinforcement during initial stoma creation reduces PSH incidence and potentially its repair, without an increase in peristomal complications.However, substantial heterogeneity among included RCTs limits confidence in the results.

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“…One‐year follow‐up data on 201 Scandinavian patients showed no difference in parastomal hernia rates using either a cruciate fascial incision, circular incision or prophylactic mesh [1]. A well‐performed French multicentre trial has recently shown mesh to be of little value in preventing parastomal herniation (PSH) in the first 2 years [2].…”

mentioning

confidence: 99%