Optimising surgical anastomosis in ileocolic resection for Crohn's disease with respect to recurrence and functionality: two international parallel randomized controlled trials comparing handsewn (END-to-end or Kono-S) to stapled anastomosis (HAND2END and the End2End STUDIES).
CD
Crohn’s disease
Endoscopic recurrence
Handsewn anastomosis
IBD
Ileocaecal resection
Ileocolic anastomosis
Kono-S
Stapled anastomosis
Surgical recurrence
Journal
BMC surgery
ISSN: 1471-2482
Titre abrégé: BMC Surg
Pays: England
ID NLM: 100968567
Informations de publication
Date de publication:
26 Feb 2024
26 Feb 2024
Historique:
received:
30
10
2023
accepted:
01
02
2024
medline:
27
2
2024
pubmed:
27
2
2024
entrez:
26
2
2024
Statut:
epublish
Résumé
The most common intestinal operation in Crohn's disease (CD) is an ileocolic resection. Despite optimal surgical and medical management, recurrent disease after surgery is common. Different types of anastomoses with respect to configuration and construction can be made after resection for example, handsewn (end-to-end and Kono-S) and stapled (side-to-side). The various types of anastomoses might affect endoscopic recurrence and its assessment, the functional outcome, and costs. The objective of the present study is to compare the three types of anastomoses with respect to endoscopic recurrence at 6 months, gastrointestinal function, and health care consumption. This is a randomized controlled multicentre superiority trial, allocating patients either to side-to-side stapled anastomosis as advised in current guidelines or a handsewn anastomoses (an end-to-end or Kono-S). It is hypothesized that handsewn anastomoses do better than stapled, and end-to-end perform better than the saccular Kono-S. Two international studies with a similar setup will be conducted mainly in the Netherlands (End2End) and Italy (HAND2END). Patients diagnosed with CD, aged over 16 years in the Netherlands and 18 years in Italy requiring (re)resection of the (neo)terminal ileum are eligible. The first part of the study compares the two handsewn anastomoses with the stapled anastomosis. To detect a clinically relevant difference of 25% in endoscopic recurrence, a total of 165 patients will be needed in the Netherlands and 189 patients in Italy. Primary outcome is postoperative endoscopic recurrence (defined as Rutgeerts score ≥ i2b) at 6 months. Secondary outcomes are postoperative morbidity, gastrointestinal function, quality of life (QoL) and costs. The research question addresses a knowledge gap within the general practice elucidating which type of anastomosis is superior in terms of endoscopic and clinical recurrence, functionality, QoL and health care consumption. The results of the proposed study might change current practice in contrast to what is advised by the guidelines. NCT05246917 for HAND2END and NCT05578235 for End2End ( http://www. gov/ ).
Sections du résumé
BACKGROUND
BACKGROUND
The most common intestinal operation in Crohn's disease (CD) is an ileocolic resection. Despite optimal surgical and medical management, recurrent disease after surgery is common. Different types of anastomoses with respect to configuration and construction can be made after resection for example, handsewn (end-to-end and Kono-S) and stapled (side-to-side). The various types of anastomoses might affect endoscopic recurrence and its assessment, the functional outcome, and costs. The objective of the present study is to compare the three types of anastomoses with respect to endoscopic recurrence at 6 months, gastrointestinal function, and health care consumption.
METHODS
METHODS
This is a randomized controlled multicentre superiority trial, allocating patients either to side-to-side stapled anastomosis as advised in current guidelines or a handsewn anastomoses (an end-to-end or Kono-S). It is hypothesized that handsewn anastomoses do better than stapled, and end-to-end perform better than the saccular Kono-S. Two international studies with a similar setup will be conducted mainly in the Netherlands (End2End) and Italy (HAND2END). Patients diagnosed with CD, aged over 16 years in the Netherlands and 18 years in Italy requiring (re)resection of the (neo)terminal ileum are eligible. The first part of the study compares the two handsewn anastomoses with the stapled anastomosis. To detect a clinically relevant difference of 25% in endoscopic recurrence, a total of 165 patients will be needed in the Netherlands and 189 patients in Italy. Primary outcome is postoperative endoscopic recurrence (defined as Rutgeerts score ≥ i2b) at 6 months. Secondary outcomes are postoperative morbidity, gastrointestinal function, quality of life (QoL) and costs.
DISCUSSION
CONCLUSIONS
The research question addresses a knowledge gap within the general practice elucidating which type of anastomosis is superior in terms of endoscopic and clinical recurrence, functionality, QoL and health care consumption. The results of the proposed study might change current practice in contrast to what is advised by the guidelines.
TRIAL REGISTRATION
BACKGROUND
NCT05246917 for HAND2END and NCT05578235 for End2End ( http://www.
CLINICALTRIALS
RESULTS
gov/ ).
Identifiants
pubmed: 38408943
doi: 10.1186/s12893-024-02340-3
pii: 10.1186/s12893-024-02340-3
doi:
Banques de données
ClinicalTrials.gov
['NCT05578235', 'NCT05246917']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
71Informations de copyright
© 2024. The Author(s).
Références
Bernstein CN, Loftus EV Jr, Ng SC, Lakatos PL, Moum B. Hospitalisations and surgery in Crohn’s disease. Gut. 2012;61(4):622–9.
doi: 10.1136/gutjnl-2011-301397
pubmed: 22267595
Bouguen G, Peyrin-Biroulet L. Surgery for adult Crohn’s disease: what is the actual risk? Gut. 2011;60(9):1178–81.
doi: 10.1136/gut.2010.234617
pubmed: 21610273
Caprilli R, Gassull MA, Escher JC, Moser G, Munkholm P, Forbes A, Hommes DW, Lochs H, Angelucci E, Cocco A, et al. European evidence based consensus on the diagnosis and management of Crohn’s disease: special situations. Gut. 2006;55(Suppl 1):i36–58.
doi: 10.1136/gut.2005.081950c
pubmed: 16481630
pmcid: 1859996
Orlando A, Mocciaro F, Renna S, Scimeca D, Rispo A, Lia Scribano M, Testa A, Aratari A, Bossa F, Tambasco R, et al. Early post-operative endoscopic recurrence in Crohn’s disease patients: data from an Italian group for the study of inflammatory bowel disease (IG-IBD) study on a large prospective multicenter cohort. J Crohns Colitis. 2014;8(10):1217–21.
doi: 10.1016/j.crohns.2014.02.010
pubmed: 24630485
Peyrin-Biroulet L, Harmsen WS, Tremaine WJ, Zinsmeister AR, Sandborn WJ, Loftus EV Jr. Surgery in a population-based cohort of Crohn’s disease from Olmsted County, Minnesota (1970-2004). Am J Gastroenterol. 2012;107(11):1693–701.
doi: 10.1038/ajg.2012.298
pubmed: 22945286
pmcid: 3572861
Torres J, Mehandru S, Colombel JF, Peyrin-Biroulet L. Crohn’s disease. Lancet. 2017;389(10080):1741–55.
doi: 10.1016/S0140-6736(16)31711-1
pubmed: 27914655
Ponsioen CY, de Groof EJ, Eshuis EJ, Gardenbroek TJ, Bossuyt PMM, Hart A, Warusavitarne J, Buskens CJ, van Bodegraven AA, Brink MA, et al. Laparoscopic ileocaecal resection versus infliximab for terminal ileitis in Crohn’s disease: a randomised controlled, open-label, multicentre trial. Lancet Gastroenterol Hepatol. 2017;2(11):785–92.
doi: 10.1016/S2468-1253(17)30248-0
pubmed: 28838644
Stevens TW, Haasnoot ML, D’Haens GR, Buskens CJ, de Groof EJ, Eshuis EJ, Gardenbroek TJ, Mol B, Stokkers PCF, Bemelman WA, et al. Laparoscopic ileocaecal resection versus infliximab for terminal ileitis in Crohn’s disease: retrospective long-term follow-up of the LIR!C trial. Lancet Gastroenterol Hepatol. 2020;5(10):900–7.
doi: 10.1016/S2468-1253(20)30117-5
pubmed: 32619413
Hammoudi N, Auzolle C, Tran Minh ML, Boschetti G, Bezault M, Buisson A, Pariente B, Treton X, Seksik P, Fumery M, et al. Postoperative endoscopic recurrence on the Neoterminal ileum but not on the anastomosis is mainly driving long-term outcomes in Crohn’s disease. Am J Gastroenterol. 2020;115(7):1084–93.
doi: 10.14309/ajg.0000000000000638
pubmed: 32618659
Rivière P, Vermeire S, Irles-Depe M, Van Assche G, Rutgeerts P, Denost Q, Wolthuis A, D’Hoore A, Laharie D, Ferrante M. Rates of postoperative recurrence of Crohn’s disease and effects of immunosuppressive and biologic therapies. Clin Gastroenterol Hepatol. 2021;19(4):713–720.e711.
doi: 10.1016/j.cgh.2020.03.064
pubmed: 32272248
Becker MAJ. Does de Willebois E, Bemelman WA, Wildenberg ME, Buskens CJ: role of the mesentery in Crohn’s terminal ileitis. Clin Colon Rectal Surg. 2022;35(4):316–20.
doi: 10.1055/s-0042-1743589
pubmed: 35975109
pmcid: 9376045
van der Does de Willebois EM. Mesenteric SParIng versus extensive mesentereCtomY in primary ileocolic resection for ileocaecal Crohn's disease (SPICY): study protocol for randomized controlled trial. BJS Open. 2022;6(1).
Katsuno H, Maeda K, Hanai T, Masumori K, Koide Y, Kono T. Novel antimesenteric functional end-to-end handsewn (Kono-S) anastomoses for Crohn’s disease: a report of surgical procedure and short-term outcomes. Dig Surg. 2015;32(1):39–44.
doi: 10.1159/000371857
pubmed: 25678306
Alibert L, Betton L, Falcoz A, Manceau G, Benoist S, Zerbib P, Podevin J, Maggiori L, Brouquet A, Tyrode G, et al. Does KONO-S anastomosis reduce recurrence in Crohn's disease compared to conventional ileocolonic anastomosis? A nationwide propensity score-matched study from GETAID Chirurgie group (KoCoRICCO study). J Crohns Colitis. 2023;17.
Luglio G, Corcione F. Stapled versus handsewn methods for ileocolic anastomoses. Tech Coloproctol. 2019;23(11):1093–5.
doi: 10.1007/s10151-019-02105-8
pubmed: 31729620
Steger J, Jell A, Ficht S, Ostler D, Eblenkamp M, Mela P, Wilhelm D. Systematic review and Meta-analysis on colorectal anastomotic techniques. Ther Clin Risk Manag. 2022;18:523–39.
doi: 10.2147/TCRM.S335102
pubmed: 35548666
pmcid: 9081039
Celentano V, Pellino G, Spinelli A, Selvaggi F, Celentano V, Pellino G, Rottoli M, Poggioli G, Sica G, Giglio MC, et al. Anastomosis configuration and technique following ileocaecal resection for Crohn’s disease: a multicentre study. Updat Surg. 2021;73(1):149–56.
doi: 10.1007/s13304-020-00918-z
Gajendran M, Bauer AJ, Buchholz BM, Watson AR, Koutroubakis IE, Hashash JG, Ramos-Rivers C, Shah N, Lee KK, Cruz RJ, et al. Ileocecal anastomosis type significantly influences long-term functional status, quality of life, and healthcare utilization in postoperative Crohn’s disease patients independent of inflammation recurrence. Am J Gastroenterol. 2018;113(4):576–83.
doi: 10.1038/ajg.2018.13
pubmed: 29610509
Hammoudi N, Cazals-Hatem D, Auzolle C, Gardair C, Ngollo M, Bottois H, Nancey S, Pariente B, Buisson A, Treton X, et al. Association between microscopic lesions at Ileal resection margin and recurrence after surgery in patients with Crohn’s disease. Clin Gastroenterol Hepatol. 2020;18(1):141–149.e142.
doi: 10.1016/j.cgh.2019.04.045
pubmed: 31042575
Rutgeerts P, Goboes K, Peeters M, Hiele M, Penninckx F, Aerts R, Kerremans R, Vantrappen G. Effect of faecal stream diversion on recurrence of Crohn’s disease in the neoterminal ileum. Lancet. 1991;338(8770):771–4.
doi: 10.1016/0140-6736(91)90663-A
pubmed: 1681159
Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7.
doi: 10.7326/0003-4819-158-3-201302050-00583
pubmed: 23295957
pmcid: 5114123
Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hróbjartsson A, Schulz KF, Parulekar WR, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. Bmj. 2013;346:e7586.
doi: 10.1136/bmj.e7586
pubmed: 23303884
pmcid: 3541470
Kono T, Ashida T, Ebisawa Y, Chisato N, Okamoto K, Katsuno H, Maeda K, Fujiya M, Kohgo Y, Furukawa H. A new antimesenteric functional end-to-end handsewn anastomosis: surgical prevention of anastomotic recurrence in Crohn’s disease. Dis Colon Rectum. 2011;54(5):586–92.
doi: 10.1007/DCR.0b013e318208b90f
pubmed: 21471760
Gecse K, Lowenberg M, Bossuyt P, Rutgeerts PJ, Vermeire S, Stitt L, Vandervoort MK, Sandborn W, Feagan BG, Samaan MA. Sa1198 agreement among experts in the endoscopic evaluation of postoperative recurrence in Crohn’s disease using the Rutgeerts score. Gastroenterology. 2014;5(146):S-227.
doi: 10.1016/S0016-5085(14)60802-7
Crohn BB, Ginzburg L, Oppenheimer GD. Landmark article Oct 15, 1932. Regional ileitis. A pathological and clinical entity. By Burril B. Crohn, Leon Ginzburg, and Gordon D. Oppenheimer. Jama. 1984;251(1):73–9.
doi: 10.1001/jama.1984.03340250053024
pubmed: 6361290
Rivière P, Pekow J, Hammoudi N, Wils P, De Cruz P, Wang CP, Mañosa M, Ollech J, Allez M, Nachury M, et al. Comparison of the risk of Crohn’s disease postoperative recurrence between modified Rutgeerts score i2a and i2b categories: an individual patient data Meta-analysis. J Crohns Colitis. 2023;17(2):269–76.
doi: 10.1093/ecco-jcc/jjac137
pubmed: 36124813
Adamina M, Bonovas S, Raine T, Spinelli A, Warusavitarne J, Armuzzi A, Bachmann O, Bager P, Biancone L, Bokemeyer B, et al. ECCO guidelines on therapeutics in Crohn’s disease: surgical treatment. J Crohns Colitis. 2020;14(2):155–68.
doi: 10.1093/ecco-jcc/jjz187
pubmed: 31742338
De Cruz P, Kamm MA, Hamilton AL, Ritchie KJ, Krejany EO, Gorelik A, Liew D, Prideaux L, Lawrance IC, Andrews JM, et al. Crohn’s disease management after intestinal resection: a randomised trial. Lancet. 2015;385(9976):1406–17.
doi: 10.1016/S0140-6736(14)61908-5
pubmed: 25542620
Ma C, Gecse KB, Duijvestein M, Sandborn WJ, Zou G, Shackelton LM, Stitt LW, Parker CE, Bossuyt P, Löwenberg M, et al. Reliability of endoscopic evaluation of postoperative recurrent Crohn’s disease. Clin Gastroenterol Hepatol. 2020;18(9):2139–2141.e2132.
doi: 10.1016/j.cgh.2019.08.046
pubmed: 31473359
Reinisch W, Mishkin DS, Oh YS, Schreiber S, Hussain F, Jacob R, Hassanali A, Daperno M. Impact of various central endoscopy reading models on treatment outcome in Crohn’s disease using data from the randomized, controlled, exploratory cohort arm of the BERGAMOT trial. Gastrointest Endosc. 2021;93(1):174–182.e172.
doi: 10.1016/j.gie.2020.05.020
pubmed: 32464142
van der Does de Willebois EM, Duijvestein M, Wasmann KA, D’Haens GR, van der Bilt JD, Mundt MW, Hompes R, van der Vlugt M, Buskens CJ, Bemelman WA. Endoscopic recurrence or anastomotic wound healing phenomenon after ileocolic resection for Crohn’s disease: the challenges of accurate endoscopic scoring. J Crohns Colitis. 2023;17(5):693–9.
doi: 10.1093/ecco-jcc/jjac175
pubmed: 36382539
Dziki AJ, Duncan MD, Harmon JW, Saini N, Malthaner RA, Trad KS, Fernicola MT, Hakki F, Ugarte RM. Advantages of handsewn over stapled bowel anastomosis. Dis Colon Rectum. 1991;34(6):442–8.
doi: 10.1007/BF02049926
pubmed: 1953849
Ikeuchi H, Kusunoki M, Yamamura T. Long-term results of stapled and hand-sewn anastomoses in patients with Crohn’s disease. Dig Surg. 2000;17(5):493–6.
doi: 10.1159/000051946
pubmed: 11124554
McLeod RS, Wolff BG, Ross S, Parkes R, McKenzie M. Recurrence of Crohn’s disease after ileocolic resection is not affected by anastomotic type: results of a multicenter, randomized, controlled trial. Dis Colon Rectum. 2009;52(5):919–27.
doi: 10.1007/DCR.0b013e3181a4fa58
pubmed: 19502857
Luglio G, Rispo A, Imperatore N, Giglio MC, Amendola A, Tropeano FP, Peltrini R, Castiglione F, De Palma GD, Bucci L. Surgical prevention of anastomotic recurrence by excluding mesentery in Crohn’s disease: the SuPREMe-CD study - a randomized clinical trial. Ann Surg. 2020;272(2):210–7.
doi: 10.1097/SLA.0000000000003821
pubmed: 32675483