Comparing Manual Versus Stapled Side to Side Ileocolic Anastomosis in Crohn's Disease

Not Applicable

Recruiting

• Conditions: Ileocolitis; Crohn's Ileocolitis; IBD; Crohn Disease
• Interventions: Procedure: Handsewn anastomosis

• Registration Number: NCT05246917
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

RESEARCH QUESTION Are handsewn (end to end and Kono S side to side) anastomoses superior to side to side stapled anastomosis after ileocolic resection for Crohn's disease with respect to endoscopic recurrence, gastrointestinal function and costs.

HYPOTHESIS Stapled side anastomosis advised in ECCO guidelines heal with ulcerations on the staple line causing systematic over scoring of endoscopic recurrence leading to unjustified restarting of expensive drugs reducing QOL and increasing costs. Side to side saccular configuration causes stasis affecting recurrence and dysfunction.

DESIGN Randomised superiority study

POPULATION Patients with Crohn requiring (re)resection of the (neo)terminal ileum

INTERVENTION Kono S and end to end hand sewn anastomosis

USUAL CARE Side to side stapled anastomosis

OUTCOME Endoscopic recurrence (local and central reading) at 6 months

SAMPLE 25% reduction in 2:1 ratio -\> 126 + 63 = 189 patients

KEYWORDS Crohn, ileocolic resection, recurrence

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-09
• Study First Submitted QC: 2022-02-09
• Study First Posted: 2022-02-18
• Status Verified: 2022-05
• Study Start: 2022-05-25
• Last Update Submitted: 2022-05-25
• Last Update Posted: 2022-05-31
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 189

Inclusion Criteria

• Males and females aged >18 years
• Ileocolic disease or disease of the neoterminal ileum with an indication for resection
• Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, and anti-TNF therapy are permitted.
• All patients should have undergone a colonoscopy and MR enterography (or CT enterography if MR contraindicated) in last 3 months to assess extent of disease.
• Ability to comply with protocol.
• Competent and able to provide written informed consent.
• Patient must have been discussed in the local MDT

Exclusion Criteria

• Inability to give informed consent.
• Patients less than 16 years of age.
• Patients undergoing repeated ileocolic resection.
• History of cancer < 5 years which might influence patients prognosis
• Emergent operation. Pregnant or breast feeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Handsewn ileocolic anastomosis	Handsewn anastomosis	Randomised comparison of handsewn (end-to-end and the Kono-S) with the side-to-side stapled anastomosis. to use a manual anastomosis technique avoiding stapled technique to verify if stapled anastomosis can cause ulcers at endoscopic follow up with systematic overscoring

Primary Outcome Measures

Name	Time	Method
6 months endoscopic recurrence of endoscopy using the modified Rutgeerts classification.	6 months	The comparison of 6 months endoscopic recurrence between local and central reading of recordings of endoscopy using the modified Rutgeerts classification.

Secondary Outcome Measures

Name	Time	Method
Inflammatory Bowel Disease Questionnaire (IBDQ)	1 year	Quality of life measured with IBD questionnaire
Morbidity	1 year	postoperative morbidity measure
Hospital Costs	1 year	Hospital costs per patient in both groups
Clinical Recurrence	1 year	Clinical and surgical recurrence using Clavien Dindo

Trial Locations

Locations (1)

irccs San Raffaele; 🇮🇹 Milan, Italy