HAND2END: Comparing Manual Versus Stapled Side to Side Ileocolic Anastomosis in Crohn's Disease

Sponsor

IRCCS San Raffaele (Other)

Overall Status

Recruiting

CT.gov ID

NCT05246917

Collaborator

(none)

189

Enrollment

Location

Arms

31.2

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Crohn Disease IBD Ileocolitis Crohn's Ileocolitis	Procedure: Handsewn anastomosis	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

189 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomised superiority studyRandomised superiority study

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Rct in croHn's Disease: Comparing mANual (End to End and Kono-s) Versus stapleD Side TO Side Ileocolic Anastomosis (HANDTOEND)

Actual Study Start Date :

May 25, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Handsewn ileocolic 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	Procedure: Handsewn anastomosis To perform hand sewn anastomosis (either end to end or Kono-s) during the reconstruction face of ileocolic resection
No Intervention: Side to side stapled 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

Arm

Intervention/Treatment

Experimental: Handsewn ileocolic 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

Procedure: Handsewn anastomosis

To perform hand sewn anastomosis (either end to end or Kono-s) during the reconstruction face of ileocolic resection

No Intervention: Side to side stapled anastomosis

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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