Protocol for the UK cohort study to investigate the prevention of parastomal hernia (the CIPHER study)

Tabusa, Hana; Blazeby, Jane M; Blencowe, Natalie S; Callaway, Mark; Daniels, Ian R.; Gunning, Amanda M.; Hollingworth, William; McNair, Angus G K; Murkin, Charlotte; Pinkney, Thomas; Rogers, Chris; Smart, Neil; Reeves, Barnaby C

doi:10.1111/codi.15621

Cited by 20 publications

(16 citation statements)

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“…The CIPHER study is currently investigating in an international prospective cohort, which patient and surgical factors influence the risk of developing a PSH. 34…”

Section: Discussionmentioning

confidence: 99%

Prophylactic Mesh Placement During Formation of an End-colostomy

et al. 2023

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Objective: The aim of this study was to determine if prophylactic mesh placement is an effective, safe, and cost-effective procedure to prevent parastomal hernia (PSH) formation in the long term. Background: A PSH is the most frequent complication after stoma formation. Prophylactic placement of a mesh has been suggested to prevent PSH, but long-term evidence to support this approach is scarce. Methods: In this multicentre superiority trial patients undergoing the formation of a permanent colostomy were randomly assigned to either retromuscular polypropylene mesh reinforcement or conventional colostomy formation. Primary endpoint was the incidence of a PSH after 5 years. Secondary endpoints were morbidity, mortality, quality of life, and cost-effectiveness. Results: A total of 150 patients were randomly assigned to the mesh group (n = 72) or nonmesh group (n = 78). For the long-term follow-up, 113 patients were analyzed, and 37 patients were lost to follow-up. After a median follow-up of 60 months (interquartile range: 48.6–64.4), 49 patients developed a PSH, 20 (27.8%) in the mesh group and 29 (37.2%) in the nonmesh group (P = 0.22; RD: −9.4%; 95% CI: −24, 5.5). The cost related to the meshing strategy was € 2.239 lower than the nonmesh strategy (95% CI: 491.18, 3985.49), and quality-adjusted life years did not differ significantly between groups (P = 0.959; 95% CI: −0.066, 0.070). Conclusions: Prophylactic mesh placement during the formation of an end-colostomy is a safe procedure but does not reduce the incidence of PSH after 5 years of follow-up. It does, however, delay the onset of PSH without a significant difference in morbidity, mortality, or quality of life, and seems to be cost-effective.

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“…The CIPHER study is currently investigating in an international prospective cohort, which patient and surgical factors influence the risk of developing a PSH. 34…”

Section: Discussionmentioning

confidence: 99%

Prophylactic Mesh Placement During Formation of an End-colostomy

et al. 2023

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“…However, this result has to be interpreted with caution because of the aforementioned difference between the ideal (reversible) trephine enlargement, predicted in our simulations, and the real (irreversible) trephine defect experienced by ostomy patients. Future research, which will hopefully include radiological measurements and data analyses in large ostomy patients’ cohorts 30 , will no doubt shed more light on the subject. Moreover, our methodology could be used in the future to assess the risks associated to trephine enlargement in a patient-specific basis.…”

Section: Discussionmentioning

confidence: 99%

Virtual simulation of the biomechanics of the abdominal wall with different stoma locations

Tuset

López-Cano

Fortuny

et al. 2022

Sci Rep

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An ostomy is a surgical procedure by which an artificial opening in the abdominal wall, known as a stoma, is created. We assess the effects of stoma location on the abdominal wall mechanics. We perform three-dimensional finite element simulations on an anatomy model which was generated on the basis of medical images. Our simulation methodology is entirely based on open source software. We consider seventeen different locations for the stoma incision (trephine) and we simulate the mechanical response of the abdominal wall when an intraabdominal pressure as high as 20 kPa is applied. We focus on factors related to the risk of parastomal hernia development such as the deformation experienced by the abdominal wall, the stress levels supported by its tissues and the corresponding level of trephine enlargement. No significant dependence was found between stoma location and the levels of abdominal wall deformations or stress supported by tissues, except for the case with a stoma located on the linea alba. Trephine perimeter and area respectively increased by as much as $$44\%$$ 44 % and $$85\%$$ 85 % . The level of trephine deformation depends on stoma location with considerably higher trephine enlargements found in stomas laterally located with respect to the rectus abdominis muscle.

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“…Further studies are needed to understand better the influence of various surgical factors, both mesh and nonmesh related, on the risk of PSH. To this end, although the ongoing CIPHER study predominantly includes patients who do not have mesh prophylaxis [32], its results will be useful in providing better evidence on the extent to which other surgical factors influence the risk of PSH. This evidence could be used to update the model described here and determine priorities for future research [65].…”

Section: Discussionmentioning

confidence: 99%

“…In the UK, the National Institute for Health Research has prioritised research to understand factors influencing the risk of PSH and funded a cohort study to investigate the prevention of Parastomal HERnia (CIPHER study) [32]. This study has recruited >2,400 patients since 1 January 2018 from 80 NHS acute trusts across the UK.…”

Section: Introductionmentioning

confidence: 99%

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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Protocol for the UK cohort study to investigate the prevention of parastomal hernia (the CIPHER study)

Abstract: This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

Cited by 20 publications

References 20 publications

Prophylactic Mesh Placement During Formation of an End-colostomy

Prophylactic Mesh Placement During Formation of an End-colostomy

Virtual simulation of the biomechanics of the abdominal wall with different stoma locations

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

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