PHaLIR: prevent hernia after loop ileostomy reversal-a study protocol for a randomized controlled multicenter study.
Hernia
Loop ileostomy reversal
Prevent hernia
Rectal cancer
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
08 Sep 2023
08 Sep 2023
Historique:
received:
08
12
2022
accepted:
05
06
2023
medline:
11
9
2023
pubmed:
9
9
2023
entrez:
8
9
2023
Statut:
epublish
Résumé
Rectal cancer is a common cancer worldwide. Surgery for rectal cancer with low anterior resection often includes the formation of a temporary protective loop ileostomy. The temporary ostomy is later reversed in a separate operation. One complication following stoma closure is the development of a hernia at the former stoma site, and this has been reported in 7-15% of patients. The best method to avoid hernia after stoma closure is unclear. The most common closure is by suturing only, but different forms of mesh have been tried. Biological mesh has in a randomized trial halved hernia incidence after stoma reversal. Biosynthetic mesh and retromuscular mesh are currently being evaluated in ongoing studies. The present multicenter, double-blinded, randomized, controlled study will compare standard suture closure of the abdominal wall in loop ileostomy reversal with retromuscular synthetic mesh at the stoma site. The study has been approved by the Regional Ethical Review board in Stockholm. Patients aged 18-90 years, operated on with low anterior resection and a protective loop ileostomy for rectal cancer and planned for ileostomy reversal, will be considered for inclusion in the study. Randomization will be 1:1 on the operation day with concealed envelopes. The estimated sample size is intended to evaluate the superiority of the experimental arm and to detect a reduction of hernia occurrence from 12 to 3%. The operation method is blinded to the patients and in the chart and for the observer at the 30-day follow-up. The main outcome is hernia occurrence at the stoma site within 3 years postoperatively, diagnosed through CT with strain. Secondary outcomes are operation time, length of hospital stay, pain, and 30-day complications. This double-blinded randomized controlled superiority study will compare retromuscular synthetic mesh during the closure of loop ileostomy to standard care. If this study can show a lower frequency of hernia with the use of prophylactic mesh, it may lead to new surgical guidelines during stoma closure. ClinicalTrials.gov NCT03720262. Registered on October 25, 2018.
Sections du résumé
BACKGROUND
BACKGROUND
Rectal cancer is a common cancer worldwide. Surgery for rectal cancer with low anterior resection often includes the formation of a temporary protective loop ileostomy. The temporary ostomy is later reversed in a separate operation. One complication following stoma closure is the development of a hernia at the former stoma site, and this has been reported in 7-15% of patients. The best method to avoid hernia after stoma closure is unclear. The most common closure is by suturing only, but different forms of mesh have been tried. Biological mesh has in a randomized trial halved hernia incidence after stoma reversal. Biosynthetic mesh and retromuscular mesh are currently being evaluated in ongoing studies.
METHODS
METHODS
The present multicenter, double-blinded, randomized, controlled study will compare standard suture closure of the abdominal wall in loop ileostomy reversal with retromuscular synthetic mesh at the stoma site. The study has been approved by the Regional Ethical Review board in Stockholm. Patients aged 18-90 years, operated on with low anterior resection and a protective loop ileostomy for rectal cancer and planned for ileostomy reversal, will be considered for inclusion in the study. Randomization will be 1:1 on the operation day with concealed envelopes. The estimated sample size is intended to evaluate the superiority of the experimental arm and to detect a reduction of hernia occurrence from 12 to 3%. The operation method is blinded to the patients and in the chart and for the observer at the 30-day follow-up. The main outcome is hernia occurrence at the stoma site within 3 years postoperatively, diagnosed through CT with strain. Secondary outcomes are operation time, length of hospital stay, pain, and 30-day complications.
DISCUSSION
CONCLUSIONS
This double-blinded randomized controlled superiority study will compare retromuscular synthetic mesh during the closure of loop ileostomy to standard care. If this study can show a lower frequency of hernia with the use of prophylactic mesh, it may lead to new surgical guidelines during stoma closure.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov NCT03720262. Registered on October 25, 2018.
Identifiants
pubmed: 37684648
doi: 10.1186/s13063-023-07430-w
pii: 10.1186/s13063-023-07430-w
pmc: PMC10486037
doi:
Banques de données
ClinicalTrials.gov
['NCT03720262']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
575Subventions
Organisme : Kommunfullmäktige, Stockholms Stad
ID : FoUI-953977
Informations de copyright
© 2023. BioMed Central Ltd., part of Springer Nature.
Références
Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68(6):394–424.
doi: 10.3322/caac.21492
pubmed: 30207593
Wu SW, Ma CC, Yang Y. Role of protective stoma in low anterior resection for rectal cancer: a meta-analysis. World J Gastroenterol. 2014;20(47):18031–7.
doi: 10.3748/wjg.v20.i47.18031
pubmed: 25548503
pmcid: 4273155
David GG, Slavin JP, Willmott S, Corless DJ, Khan AU, Selvasekar CR. Loop ileostomy following anterior resection: is it really temporary? Colorectal Dis. 2010;12(5):428–32.
doi: 10.1111/j.1463-1318.2009.01815.x
pubmed: 19226365
Vogel I, Reeves N, Tanis PJ, Bemelman WA, Torkington J, Hompes R, et al. Impact of a defunctioning ileostomy and time to stoma closure on bowel function after low anterior resection for rectal cancer: a systematic review and meta-analysis. Tech Coloproctol. 2021;25(7):751–60.
doi: 10.1007/s10151-021-02436-5
pubmed: 33792822
pmcid: 8187190
Vaughan-Shaw PG, Gash K, Adams K, Vallance AE, Pilkington SA, Torkington J, et al. Protocol for a multicentre, dual prospective and retrospective cohort study investigating timing of ileostomy closure after anterior resection for rectal cancer: the CLOSurE of Ileostomy Timing (CLOSE-IT) study. BMJ Open. 2018;8(10):e023305.
doi: 10.1136/bmjopen-2018-023305
pubmed: 30327406
pmcid: 6196810
Ourô S, Ferreira MP, Albergaria D, Maio R. Loop ileostomy in rectal cancer surgery: factors predicting reversal and stoma related morbidity. Langenbecks Arch Surg. 2021;406(3):843–53.
doi: 10.1007/s00423-021-02169-x
pubmed: 33851240
Anaraki F, Vafaie M, Behboo R, Maghsoodi N, Esmaeilpour S, Safaee A. Quality of life outcomes in patients living with stoma. Indian J Palliat Care. 2012;18(3):176–80.
doi: 10.4103/0973-1075.105687
pubmed: 23439841
pmcid: 3573471
Nasvall P, Dahlstrand U, Lowenmark T, Rutegard J, Gunnarsson U, Strigard K. Quality of life in patients with a permanent stoma after rectal cancer surgery. Qual Life Res. 2017;26(1):55–64.
doi: 10.1007/s11136-016-1367-6
pubmed: 27444778
Demetriades D, Pezikis A, Melissas J, Parekh D, Pickles G. Factors influencing the morbidity of colostomy closure. Am J Surg. 1988;155(4):594–6.
doi: 10.1016/S0002-9610(88)80416-1
pubmed: 3354784
Porter JA, Salvati EP, Rubin RJ, Eisenstat TE. Complications of colostomies. Dis Colon Rectum. 1989;32(4):299–303.
doi: 10.1007/BF02553484
pubmed: 2924670
Vonk-Klaassen SM, de Vocht HM, den Ouden ME, Eddes EH, Schuurmans MJ. Ostomy-related problems and their impact on quality of life of colorectal cancer ostomates: a systematic review. Qual Life Res. 2016;25(1):125–33.
doi: 10.1007/s11136-015-1050-3
pubmed: 26123983
Muysoms FE, Miserez M, Berrevoet F, Campanelli G, Champault GG, Chelala E, et al. Classification of primary and incisional abdominal wall hernias. Hernia. 2009;13(4):407–14.
doi: 10.1007/s10029-009-0518-x
pubmed: 19495920
pmcid: 2719726
Oriel BS, Chen Q, Itani KMF. Incidence, recurrence and risk factors of hernias following stoma reversal. Am J Surg. 2017;214(2):232–8.
doi: 10.1016/j.amjsurg.2017.04.014
pubmed: 28596044
Nguyen MT, Phatak UR, Li LT, Hicks SC, Moffett JM, Arita NA, et al. Review of stoma site and midline incisional hernias after stoma reversal. J Surg Res. 2014;190(2):504–9.
doi: 10.1016/j.jss.2014.01.046
pubmed: 24560428
Amelung FJ, de Guerre L, Consten ECJ, Kist JW, Verheijen PM, Broeders I, et al. Incidence of and risk factors for stoma-site incisional herniation after reversal. BJS Open. 2018;2(3):128–34.
doi: 10.1002/bjs5.48
pubmed: 29951636
pmcid: 5989939
Brook AJ, Mansfield SD, Daniels IR, Smart NJ. Incisional hernia following closure of loop ileostomy: the main predictor is the patient, not the surgeon. Surgeon. 2018;16(1):20–6.
doi: 10.1016/j.surge.2016.03.004
pubmed: 27161097
De Keersmaecker G, Beckers R, Heindryckx E, Kyle-Leinhase I, Pletinckx P, Claeys D, et al. Retrospective observational study on the incidence of incisional hernias after reversal of a temporary diverting ileostomy following rectal carcinoma resection with follow-up CT scans. Hernia. 2016;20(2):271–7.
doi: 10.1007/s10029-015-1419-9
pubmed: 26350395
Sharp SP, Francis JK, Valerian BT, Canete JJ, Chismark AD, Lee EC. Incidence of ostomy site incisional hernias after stoma closure. Am Surg. 2015;81(12):1244–8.
doi: 10.1177/000313481508101226
pubmed: 26736162
Fazekas B, Fazekas B, Hendricks J, Smart N, Arulampalam T. The incidence of incisional hernias following ileostomy reversal in colorectal cancer patients treated with anterior resection. Ann R Coll Surg Engl. 2017;99(4):319–24.
doi: 10.1308/rcsann.2016.0347
pubmed: 27869487
Eklöv K, Viktorsson FZ, Frosztega E, Bringman S, Nygren J, Everhov ÅH. Hernia at the stoma site after loop ileostomy reversal. Int J Colorectal Dis. 2020;35(5):887–95.
doi: 10.1007/s00384-020-03542-w
pubmed: 32124049
Kaneko T, Funahashi K, Ushigome M, Kagami S, Goto M, Koda T, et al. Incidence of and risk factors for incisional hernia after closure of temporary ileostomy for colorectal malignancy. Hernia. 2019;23(4):743–8. https://doi.org/10.1007/s10029-018-1855-4 .
doi: 10.1007/s10029-018-1855-4
pubmed: 30426253
Muysoms FE, Dietz UA. Prophylactic meshes in the abdominal wall. German version. Chirurg. 2016;87(9):751–61.
doi: 10.1007/s00104-016-0245-7
pubmed: 27492376
Maggiori L, Moszkowicz D, Zappa M, Mongin C, Panis Y. Bioprosthetic mesh reinforcement during temporary stoma closure decreases the rate of incisional hernia: a blinded, case-matched study in 94 patients with rectal cancer. Surgery. 2015;158(6):1651–7.
doi: 10.1016/j.surg.2015.07.004
pubmed: 26260286
Warren JA, Beffa LR, Carbonell AM, Cull J, Sinopoli B, Ewing JA, et al. Prophylactic placement of permanent synthetic mesh at the time of ostomy closure prevents formation of incisional hernias. Surgery. 2018;163(4):839–46.
doi: 10.1016/j.surg.2017.09.041
pubmed: 29224706
Peltrini R, Imperatore N, Altieri G, Castiglioni S, Di Nuzzo MM, Grimaldi L, et al. Prevention of incisional hernia at the site of stoma closure with different reinforcing mesh types: a systematic review and meta-analysis. Hernia. 2021;25(3):639–48.
doi: 10.1007/s10029-021-02393-w
pubmed: 33713204
pmcid: 8197707
Liu DS, Banham E, Yellapu S. Prophylactic mesh reinforcement reduces stomal site incisional hernia after ileostomy closure. World J Surg. 2013;37(9):2039–45.
doi: 10.1007/s00268-013-2109-3
pubmed: 23716028
Bea C. Prophylactic biological mesh reinforcement versus standard closure of stoma site (ROCSS): a multicentre, randomised controlled trial. Lancet (London, England). 2020;395(10222):417–26.
doi: 10.1016/S0140-6736(19)32637-6
Bracale U. Prevention of incisional hernia with biosynthetic mesh at the site of temporary ileostomy closure (PRINCESS) (PRINCESS). 2022.
Müller S, Weyhe D, Herrle F, Horvath P, Bachmann R, von Ehrlich-Treuenstätt V, et al. Prophylactic effect of retromuscular mesh placement during loop ileostomy closure on incisional hernia incidence-a multicentre randomised patient- and observer-blind trial (P.E.L.I.O.N trial). Trials. 2023;24(1):76.
doi: 10.1186/s13063-023-07089-3
pubmed: 36726155
pmcid: 9890770
Reinforcement of Closure of Stoma Site (ROCSS) Collaborative and West Midlands Research Collaborative. Prophylactic biological mesh reinforcement versus standard closure of stoma site (ROCSS): a multicentre, randomised controlled trial. Lancet (London, England). 2020;395(10222):417–26.
doi: 10.1016/S0140-6736(19)32637-6