Status:
UNKNOWN
RISK FACTORS FOR ANASTOMOTIC LEAKAGE FOLLOWING TOTAL OR SUBTOTAL COLECTOMY (RIALTCOT)
Lead Sponsor:
Hospital Universitario Ramon y Cajal
Conditions:
Total Colectomy
Subtotal Colectomy
Eligibility:
All Genders
18+ years
Brief Summary
Higher anastomotic leakage (AL) rate is reported after ileosigmoid (ISA) or ileorectal anastomosis (IRA) in total or subtotal colectomy (TSC) compared to colonic or colorectal anastomosis. An AL reduc...
Detailed Description
Ileorectal (IRA) or ileosigmoid anastomosis (ISA) following Total or Subtotal Colectomy (TSC) are frequently performed in inflammatory bowel disease (IBD) (Crohn´s disease, ulcerative colitis and inde...
Eligibility Criteria
Inclusion
- (1) over 18 years old
- (2) underwent restorative TSC with ISA or IRA anastomosis (emergent or elective)
- (3) with/without loop ileostomy
- (4) between 2013-2019
Exclusion
- (1) non-restorative TSC
- (2) previous colorectal resection
- (3) deferred anastomosis in trauma surgery and
- (4) other surgical resection in the same procedure.
Key Trial Info
Start Date :
August 10 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2021
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04512326
Start Date
August 10 2020
End Date
November 30 2021
Last Update
August 13 2020
Active Locations (1)
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1
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034