Dataset Information

Mesenteric SParIng versus extensive mesentereCtomY in primary ileocolic resection for ileocaecal Crohn's disease (SPICY): study protocol for randomized controlled trial.

ABSTRACT:

Background

There is emerging evidence to suggest that Crohn's disease (CD) may be a disease of the mesentery, rather than of the bowel alone. A more extensive mesenteric resection, removing an increased volume of mesentery and lymph nodes to prevent recurrence of CD, may improve clinical outcomes. This study aims to analyse whether more extensive 'oncological' mesenteric resection reduces the recurrence rate of CD.

Methods

This is an international multicentre randomized controlled study, allocating patients to either group 1-mesenteric sparing ileocolic resection (ICR), the current standard procedure for CD, or group 2-extensive mesenteric ICR, up to the level of the ileocolic trunk. To detect a clinically relevant difference of 25 per cent in endoscopic recurrence at 6 months, a total of 138 patients is required (including 10 per cent dropout). Patients aged over 16 with CD undergoing primary ICR are eligible. Primary outcome is 6-month postoperative endoscopic recurrence rate (modified Rutgeerts score of greater than or equal to i2b). Secondary outcomes are postoperative morbidity, clinical recurrence, quality of life, and the need for (re)starting immunosuppressive medication. For long-term results, patients will be followed up for up to 5 years to determine the reoperation rate for recurrence of disease at the anastomotic site.

Conclusion

Analysing these two treatment strategies in a head-to-head comparison will allow an objective evaluation of the clinical relevance of extensive mesenteric resection in CD. If a clinical benefit can be demonstrated, this could result in changes to guidelines which currently recommend close bowel resection.

Registration number

NCT00287612 (http://www.clinicaltrials.gov).

SUBMITTER: van der Does de Willebois EML

PROVIDER: S-EPMC8848735 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature

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Publications

Mesenteric SParIng versus extensive mesentereCtomY in primary ileocolic resection for ileocaecal Crohn's disease (SPICY): study protocol for randomized controlled trial.

van der Does de Willebois E M L EML

BJS open 20220101 1

<h4>Background</h4>There is emerging evidence to suggest that Crohn's disease (CD) may be a disease of the mesentery, rather than of the bowel alone. A more extensive mesenteric resection, removing an increased volume of mesentery and lymph nodes to prevent recurrence of CD, may improve clinical outcomes. This study aims to analyse whether more extensive 'oncological' mesenteric resection reduces the recurrence rate of CD.<h4>Methods</h4>This is an international multicentre randomized controlled ...[more]

PMID: 35171266

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Project description:IntroductionIleocolic resection for Crohn's disease traditionally does not include a high ligation of the ileocolic pedicle, and most commonly is performed with a stapled side-to-side ileocolic anastomosis. The mesentery has recently been implicated in the pathophysiology of Crohn's disease. Two techniques have been developed and are associated with reduced postoperative recurrence: the Kono-S anastomosis that excludes diseased mesentery and extended mesenteric excision that resects diseased mesentery. We aimed to assess the technical feasibility and safety of a novel combination of techniques: mesenteric excision and exclusion.TechniquesThis initial report is a single-center descriptive study of consecutive adults who underwent mesenteric excision and exclusion for primary or recurrent ileocolic Crohn's disease from September 2020 to June 2021. Medication exposure and endoscopic balloon dilation before surgery were recorded. Phenotype was classified using the Montreal Classification. Thirty-day outcomes were reported. A video of the mesenteric excision and exclusion including the Kono-S anastomosis is presented.ResultsTwenty-two patients with ileocolic Crohn's disease underwent mesenteric excision and exclusion: 100% had strictures, 59% had fistulas, 81% were on biologics, and 27% had previous ileocolic resection(s). Seventy-two percent underwent laparoscopic procedures, a mesenteric defect was closed in 86%, omental flaps were fashioned in 77%, and 3 patients were diverted. Median operative time was 175 minutes. Median postoperative stay was 4 days. At 30 days, there were 2 readmissions for reintervention: 1 seton placement and 1 percutaneous drainage of a sterile collection. There were no cases of intra-abdominal sepsis or anastomotic leak.ConclusionsMesenteric excision and exclusion represents an innovative, progressive, and promising approach that appears to be highly feasible and safe. Further study is warranted to determine if mesenteric excision and exclusion is associated with reduced postoperative recurrence of ileocolic Crohn's disease.

Project description:BackgroundThe structures of the mesentery including adipose tissue, nerves, and lymphatics play an important role in the pathogenesis and disease progression of Crohn's disease (CD). Conventional surgical resection for CD usually does not involve resecting the mesentery en bloc with the specimen. This contrasts with complete mesocolic excision (CME) in colorectal cancer, which involves radical resection of the mesentery. Preliminary evidence from smaller studies suggests that applying the principle of mesocolic excision to CD surgery may reduce the risk of postoperative recurrence. This randomized controlled trial is designed to test whether applying the principles of mesocolic excision to CD results in reduced postoperative recurrence. It also aims to evaluate intra- and postoperative morbidity between the two approaches.MethodsThis international, multicenter, randomized controlled trial will randomize patients (n = 116) scheduled to undergo primary ileocolic resection to either receive extensive mesenteric excision (EME) or conventional ileocolic resection with limited mesenteric excision (LME). Five sites will recruit patients in three countries. In the EME group, the mesentery is resected following CME, while avoiding the root region, i.e., 1 cm from the root of the ileocolic artery and vein. In the LME group, the mesentery is retained, i.e., "close shave" or < 3 cm from the border of bowel. The primary end point will be surgical recurrence after surgery. The secondary end points will be the postoperative endoscopic and clinical recurrence, and intra- and postoperative morbidity. Demographics, risk factors, laboratory investigations, endoscopy, postoperative prophylaxis and imaging examination will be assessed. Analysis of the primary outcome will be on an intention-to-treat basis.DiscussionIf mesocolic excision in CD reduces postoperative disease recurrence and does not increase morbidity, this trial has the potential to change practice and reduce recurrence of CD after surgical resection.Trial registrationClinical Trials.gov, ID: NCT03769922. Registered on February 27, 2019.

Dataset Information

Mesenteric SParIng versus extensive mesentereCtomY in primary ileocolic resection for ileocaecal Crohn's disease (SPICY): study protocol for randomized controlled trial.

Background

Methods

Conclusion

Registration number

Publications

Mesenteric SParIng versus extensive mesentereCtomY in primary ileocolic resection for ileocaecal Crohn's disease (SPICY): study protocol for randomized controlled trial.

Similar Datasets

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