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

• ClinicalTrials.gov Identifier: NCT05246917
• Recruitment Status: Recruiting
• First Posted: February 18, 2022
• Last Update Posted: May 31, 2022
• Sponsor: IRCCS San Raffaele
• Information provided by (Responsible Party): Vittoria Bellato, IRCCS San Raffaele

Tracking Information

• First Submitted Date: February 9, 2022
• First Posted Date: February 18, 2022
• Last Update Posted Date: May 31, 2022
• Actual Study Start Date: May 25, 2022
• Estimated Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 9, 2022)

6 months endoscopic recurrence of endoscopy using the modified Rutgeerts classification. [ Time Frame: 6 months ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 9, 2022)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparing Manual Versus Stapled Side to Side Ileocolic Anastomosis in Crohn's Disease
• Official Title: Rct in croHn's Disease: Comparing mANual (End to End and Kono-s) Versus stapleD Side TO Side Ileocolic Anastomosis (HANDTOEND)

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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomised superiority study

Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment

Condition

• Crohn Disease
• IBD
• Ileocolitis
• Crohn's Ileocolitis

Intervention

Procedure: Handsewn anastomosis

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

Study Arms

• 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

  Intervention: Procedure: Handsewn anastomosis
• 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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 9, 2022): 189
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2024
• Estimated Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 99 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: vittoria bellato, MD; +447827422840; vittoria.bellato@gmail.com

• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT05246917
• Other Study ID Numbers: 5.2
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Vittoria Bellato, IRCCS San Raffaele
• Original Responsible Party: Same as current
• Current Study Sponsor: IRCCS San Raffaele
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: IRCCS San Raffaele
• Verification Date: May 2022