Status:
UNKNOWN
Open Abdomen and Delayed Anastomosis After Anastomotic Dehiscences to Avoid Stomas
Lead Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Conditions:
Anastomotic Complication
Anastomotic Leak Small Intestine
Eligibility:
All Genders
14-100 years
Phase:
NA
Brief Summary
Phase III clinical trial to evaluate the efficacy of the open abdomen as bridging therapy to perform transit reconstruction in patients with anastomotic dehiscence. It is a randomized controlled singl...
Detailed Description
The selected patients will be those patients reoperated for an anastomotic dehiscence (intestinal, ileocolic, colo-colic or colorectal anastomosis) with localized or generalized peritonitis. Those pat...
Eligibility Criteria
Inclusion
- Patients with intestinal, ileocolic, colo-colic and colorectal anastomosis dehiscence.
Exclusion
- Dehiscence of colorectal anastomosis in the middle or lower rectum.
- Dehiscence of esophagus-gastric or gastro-intestinal anastomosis.
- Dehiscence of a colorectal anastomosis in which it is impossible to close the rectal stump.
- Failure to sign the informed consent.
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05233995
Start Date
August 1 2022
End Date
September 1 2024
Last Update
June 15 2022
Active Locations (1)
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1
Hospital Universitario Virgen del Rocío, Sevilla
Seville, Spain, 41013