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

NCT05246917 | Unknown

• 1 other identifier: 5.2
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

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

Conditions

Crohn Disease; IBD; Ileocolitis; Crohn's Ileocolitis

Keywords

Recurrence IBD; IBD; Endoscopic Recurrence; Rurgeers Score; Surgical recurrence; Crohn's Ileocolitis; Ileocolic Anastomosis; Crohn's disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Morbidity

  1 year

• Clinical Recurrence

  1 year

• Inflammatory Bowel Disease Questionnaire (IBDQ)

  1 year

• Hospital Costs

  1 year

Study Arms (2)

Handsewn ileocolic anastomosis

EXPERIMENTAL

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

Side to side stapled anastomosis

NO INTERVENTION

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

Interventions

Handsewn anastomosis PROCEDURE

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

Handsewn ileocolic anastomosis

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

irccs San Raffaele

Milan, Italy

RECRUITING

Related Publications (1)

• Haanappel AEG, Bellato V, Buskens CJ, Armuzzi A, van der Bilt JDW, de Boer NKH, Danese S, van der Does de Willebois EML, Duijvestein M, van der Horst D, Pellino G, Richir MC, Selvaggi F, Spinelli A, Vignali A, Rosati R, Bemelman WA. Optimising surgical anastomosis in ileocolic resection for Crohn's disease with respect to recurrence and functionality: two international parallel randomized controlled trials comparing handsewn (END-to-end or Kono-S) to stapled anastomosis (HAND2END and the End2End STUDIES). BMC Surg. 2024 Feb 26;24(1):71. doi: 10.1186/s12893-024-02340-3.

  PMID: 38408943 DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

vittoria bellato, MD

CONTACT

+447827422840; vittoria.bellato@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomised superiority study

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 18, 2022
• Study Start: May 25, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: May 31, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)