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Colorectal Disease
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Mesenteric excision and Kono‐S anastomosis trial (MEErKAT): A study protocol for a multicentre, 2 × 2 factorial, randomised controlled, open‐label superiority trial

A study protocol for a multicentre, 2 × 2 factorial, randomised controlled, open-label superiority trial
Authors: Deepak Selvakumar; Jamie Hall; Olivia Hawksworth; Daniel Hind; Stephen Walters; Ines Rombach; Esther Herbert; +7 Authors

Mesenteric excision and Kono‐S anastomosis trial (MEErKAT): A study protocol for a multicentre, 2 × 2 factorial, randomised controlled, open‐label superiority trial

Abstract

AbstractAimControversy exists over whether surgical technique can reduce recurrence following Crohn's resection. This study compares the rate of endoscopic recurrence after different approaches to mesenteric excision (extended/close) and anastomosis (Kono‐S/standard of care) in adult patients undergoing ileocolic resection for primary or recurrent Crohn's disease.MethodMEErKAT is a UK multicentre, 2 × 2 factorial, randomised, controlled, open‐label superiority trial where participants (target sample size = 308) are blinded and centrally randomised (1:1:1:1) to one of four groups: (1) Kono‐S + extended mesenteric resection. (2) Kono‐S + close mesenteric resection. (3) Standard anastomosis + extended mesenteric resection. (4) Standard anastomosis + close mesenteric resection. The primary outcome is time to endoscopic recurrence of disease (up to 3 years follow‐up). Secondary outcomes include rates of severe and symptomatic recurrence, complications, and quality of life scores. The locality of recurrence will be investigated using endoscopic assessment of the mucosa relative to mucosal tattoos placed at the time of operation. The degree and anastomotic locality of different immune cells will be compared before and after each intervention to better understand the mechanistic processes driving disease recurrence.ConclusionThis study will robustly evaluate the efficacy of the Kono‐S anastomosis technique and extended mesenteric excision in reducing endoscopic recurrence rates. The additive effect of these techniques and local tissue immune response will be investigated. This will provide important evidence to guide the optimal surgical technique and improve our understanding of the processes leading to recurrent disease.

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Keywords

Adult, Male, Mesentery/surgery, Anastomosis, Surgical/methods, Anastomosis, Crohn Disease/surgery, Equivalence Trials as Topic, Ileum/surgery, Colectomy/methods, United Kingdom, Colon/surgery, Treatment Outcome, Recurrence, Quality of Life, Humans, Surgical/methods, Multicenter Studies as Topic, Female

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
0
Average
Average
Average