Comparing Hand-sewn (END-TO-END or Kono-S) to Stapled Anastomosis in Ileocolic Resection for Crohn's Disease

Not Applicable

Recruiting

• Conditions: Crohn Disease
• Interventions: Procedure: stapled side-to-side anastomosis; Procedure: Handsewn anastomosis

• Registration Number: NCT05578235
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

The aim of this multicenter randomised controlled trial is to compare the handsewn (end-to-end and Kono-S) to the stapled side-to-side ileocolic anastomosis after ileocolic resection for Crohn's disease with respect to 6 months endoscopic recurrence, functional outcome and health care consumption.

Detailed Description

Within the surgical IBD society there has been a lot of attention to technical aspects of ileocolic resection aiming to reduce recurrent Crohn's disease after surgery. 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 e.g., 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. It is hypothesised that patients who had an end to end reconstruction will have less endoscopic recurrence (less overscoring, and less stases), a better function and consequently health care consumption than the stapled side to side anastomosis.

Study Timeline

• Study First Submitted: 2022-10-01
• Study First Submitted QC: 2022-10-10
• Study First Posted: 2022-10-13
• Study Start: 2023-07-13
• Status Verified: 2023-11
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2023-12-18
• Primary Completion: 2027-10-01
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

• Males and females aged >16 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 a recent update of imaging (e.g. Ultrasound, MR enterography (or CT enterography if MR is contraindicated))- 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.
• Clinically significant medical conditions within the six months before the operation : e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient.
• History of cancer < 5 years which might influence patients prognosis
• Emergent operation.
• Pregnant or breast feeding.
• Inability to follow up at 3, 6 and 12 months for postoperative assessment, imaging and endoscopy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
stapled side-to-side anastomosis	stapled side-to-side anastomosis	Standard procedure for CD, ileocolic resection with side-to-side anastomosis is done according to local practice with a linear stapler either aniso- or isoperistaltic as advised by the ECCO guidelines
Handsewn anastomosis: handsewn end-to-end or Kono-s anastomosis	Handsewn anastomosis	* Kono-S (anti-mesenteric functionel end-to-end handsewn) anastomosis is done according to the description by Kono * End-to-end handsewen anastomosis is fashioned either by enlarging the small bowel diameter by an antimesenteric incision to fit the large bowel lumen or by tailored resection of a part of the staple line of the cross stapled colon

Primary Outcome Measures

Name	Time	Method
Postoperative endoscopic recurrence at 6 months	6 months	The postoperative endoscopic recurrence at 6 months following ileocolic resection defined as Rutgeerts \> i2b by central reading

Secondary Outcome Measures

Name	Time	Method
The 5 year reoperation rate for recurrence of disease at the anastomotic site.	5 year
Post-operative 30 days complications	30 days after surgery
Histologic and clinical recurrence rate at 6 months following ileocolic resection	6 months after surgery
Number of patients in need for restarting immunosuppressive medication within the first year postoperatively for endoscopic or clinical recurrence	1 year after surgery	* Endoscopic recurrence defined as Rutgeerts \> i2b; * Clinical recurrence difned as recurrent CD-related symptoms
Inflammatory Bowel Disease Questionnaire (IBDQ)	1 year after surgery	Quality of life measured with IBD questionnaire
Hospital costs	1 year after surgery	Hospital costs per patients in each group

Trial Locations

Locations (1)

Flevoziekenhuis; 🇳🇱 Almere, Flevoland, Netherlands