NCT04512326: RIALTCOT

RISK FACTORS FOR ANASTOMOTIC LEAKAGE FOLLOWING TOTAL OR SUBTOTAL COLECTOMY (RIALTCOT)

Status unknown Last updated 13 August 2020

What this trial tests

trial testing Total or Subtotal colectomy in Total Colectomy in 500 participants. Status unknown.

Timeline

10 August 2020

Primary endpoint
30 June 2021

30 November 2021

Quick facts

Lead sponsor	Hospital Universitario Ramon y Cajal
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	500
Start date	10 August 2020
Primary completion	30 June 2021
Estimated completion	30 November 2021
Sites	1 location across Spain

Drugs / interventions tested

• Total or Subtotal colectomy

Conditions studied

• Total Colectomy — all drugs for Total Colectomy →
• Subtotal Colectomy — all drugs for Subtotal Colectomy →

Sponsor

Hospital Universitario Ramon y Cajal

Who can join

18 and older, any sex, with Total Colectomy or Subtotal Colectomy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 reduction in these cases may improve short and long terms outcomes significantly. Current evidence remains insufficient to assess AL risk after TSC, based on single-center studies or small cases series. The investigators aim to analyse and identify potential risk factors to AL following TSC and ISA or IRA, both preoperative and intraoperative in order to prevent surgical complications.

The study is set up as a retrospective multicentre observational study. Inclusion criteria are patients (1) over 18 years old, (2) underwent restorative TSC with ISA or IRA anastomosis, (3) with/without loop ileostomy (4) between 2013-2019. Exclusion criteria are: (1) non-restorative TSC, (2) previous colorectal resection, (3) deferred anastomosis in trauma surgery and (4) other surgical resection in the same procedure.

AL will be defined as a defect of the integrity of the intestinal wall at the anastomotic site leading to a communication of the intra and extraluminal or a pelvic abscess adjacent to the anastomosis according to the definition set by de International Study Group of Rectal Cancer. AL requiring no active therapeutic intervention will be classified as Grade A. AL requiring active therapeutic intervention (antibiotics and percutaneous drainage) but manageable without relaparotomy will be classified as Grade B and AL requiring re-intervention were classified as Grade C.

Multivariable logistic regression model will be used in order to assess potential AL risk factors. p value \<0,05 will be consider to indicate statistical significance.

Primary outcome is to assess potential risk factors to AL after restorative (ISA or IRA) TSC. Secondary outcomes are to identify risk factors to associated postoperative morbidity, mortality and re-admissions.

Data will be collected in each participating center enrolled in the study by the assigned principal investigator, confidentially and codified. Data will be sent to the study principal investigator. Database, patients code and email address will be provided at the study inclusion.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.