Pelvic Drain After Rectal Resection for Mid-low Rectal Cancer

Hospital Universitari Vall d'Hebron Research Institute518 enrolled

Overview

This RCT aims at assessing the effects of a pelvic drain after total mesorectal excision for mid-low rectal cancer on the rates of pelvic sepsis and anastomotic leaks.

This is a 2-arm, non-inferiority RCT. Patients undergoing total mesorectal excision for mid-low rectal cancer will be randomly assigned into two groups: * pelvic drain * no pelvic drain. Patients will be followed-up to assess the rates of anastomotic leaks, pelvic sepsis and secondary outcomes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

518

Conditions

Rectal Cancer

Interventions

Pelvic drainPROCEDURE

A pelvic drain is placed

No pelvic drain is placedOTHER

A pelvic drain is not placed

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or Female, 18 year-of-age or above * Mid or low rectal cancer * Anastomosis below the peritoneal reflection * Total mesorectal excision (TME) * Capability to understand the study * Informed consent Exclusion Criteria: * For women, pregnancy * Chronic kidney failure or hepatic failure, immunodepression, malnoutrition * Life expectancy \< 6 months * Partial mesorectal excision * Abdominoperineal excision * Multivisceral resections * Emergency surgery

Locations (1)

Hospital General Universitario Vall d´Hebron

Barcelona, Barcelona, Spain, Spain

RECRUITING