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

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

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

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease; IBD; Crohn's Ileocolitis; Ileocolitis
• Intervention / Treatment: Procedure: Handsewn anastomosis

• Study Type: Interventional
• Enrollment (Anticipated): 189
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: vittoria bellato, MD; Phone Number: +447827422840; Email: vittoria.bellato@gmail.com

Study Locations

• Italy
  • Milan, Italy
    • Recruiting
    • IRCCS San Raffaele
    • Contact: Simona Radice; Phone Number: 02.26432069
    • Principal Investigator: Vittoria Bellato, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 months endoscopic recurrence of endoscopy using the modified Rutgeerts classification.	The comparison of 6 months endoscopic recurrence between local and central reading of recordings of endoscopy using the modified Rutgeerts classification.	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: February 9, 2022
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (Actual): February 18, 2022

Study Record Updates

• Last Update Posted (Actual): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 25, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: IBD; Crohn's disease; Recurrence IBD; Endoscopic Recurrence; Rurgeers Score; Surgical recurrence; Crohn's Ileocolitis; Ileocolic Anastomosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 5.2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No