Pelvic Drain After Rectal Resection for Mid-low Rectal Cancer (GECO1)

Pelvic Drain After Rectal Resection for Mid-low Rectal Cancer: a Randomised Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Rectal Cancer
• Intervention / Treatment: Procedure: Pelvic drain; Other: No pelvic drain is placed

Detailed Description

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
• Enrollment (Anticipated): 518
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Barcelona, Barcelona, Spain, Spain, 08035
      • Recruiting
      • Hospital General Universitario Vall d´Hebron
      • Contact: Eloy Espín Basany, MD PhD; Phone Number: 6587 934 893 000; Email: eespin@vhebron.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Pelvic drain; Placement of a pelvic drain	Procedure: Pelvic drain; A pelvic drain is placed
EXPERIMENTAL: No pelvic drain; No pelvic drain placed	Other: No pelvic drain is placed; A pelvic drain is not placed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with pelvic sepsis	anastomotic leak or pelvic collections clinically or radiologically detected	0-30 days postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Management of pelvic sepsis	Type of management (medical, rediological, surgical)	0-30 days postoperatively
Postoperative complications	Overall postoperative complications	0-30 days postoperatively
CT scan or imaging needed	Necessity of performing unscheduled imaging tests	0-30 days postoperatively
Number of participants with postoperative ileus	Postoperative ileus	0-30 days postoperatively
Diagnostic delay for a leak	Days between surgery and leak detection	0-30 days postoperatively
Length of postperative stay	Days of stay after surgery	0-30 days postoperatively or until discharge
Time to flatus and bowel movement	Days between surgery and flatus/faeces	0-30 days postoperatively
Stoma presence at 1-year follow-up	Necessity of maintaining the diverting ileostomy at 1-year follow-up	12 months after surgery
Late pelvic collections	Presence of pelvic collections detected at longer follow-up intervals	up to 60 days after surgery
Small bowel obstruction	Mechanical small bowel obstruction	up to 60 days after surgery
Quality of life associated with a drain	Visual Analogue Scale 0-10 (higher score means better outcome) score of postoperative pain and wound complaints	30 days postoperatively
Any complications associated with drain removal after surgery	Safety of drain removal after surgery	up to 60 days after surgery

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2020
• Primary Completion (ANTICIPATED): September 1, 2022
• Study Completion (ANTICIPATED): September 1, 2022

Study Registration Dates

• First Submitted: September 24, 2020
• First Submitted That Met QC Criteria: October 1, 2020
• First Posted (ACTUAL): October 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 5, 2020
• Last Update Submitted That Met QC Criteria: October 1, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: GECO1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No