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