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

Crohn Disease Clinical Trial

— HAND2END  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05246917
• Other study ID #: 5.2
• Status: Recruiting
• Phase: N/A
• Start date: May 25, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2022
• Source: IRCCS San Raffaele
• Contact: vittoria bellato, MD
• Phone: +447827422840
• Email: vittoria.bellato[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 189
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Italy	irccs San Raffaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

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