Status:
UNKNOWN
Comparing Manual Versus Stapled Side to Side Ileocolic Anastomosis in Crohn's Disease
Lead Sponsor:
IRCCS San Raffaele
Conditions:
Crohn Disease
IBD
Eligibility:
All Genders
18-99 years
Phase:
NA
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 re...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
189 Patients enrolled
Trial Details
Trial ID
NCT05246917
Start Date
May 25 2022
End Date
December 31 2024
Last Update
May 31 2022
Active Locations (1)
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1
irccs San Raffaele
Milan, Italy