Pelvic Drain After Rectal Resection for Mid-low Rectal Cancer

Not Applicable

• Conditions: Rectal Cancer
• Interventions: Procedure: Pelvic drain; Other: No pelvic drain is placed

• Registration Number: NCT04573621
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

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.

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 Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-24
• Study Start: 2020-10
• Study First Submitted QC: 2020-10-01
• Last Update Submitted: 2020-10-01
• Study First Posted: 2020-10-05
• Last Update Posted: 2020-10-05
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 518

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pelvic drain	Pelvic drain	Placement of a pelvic drain
No pelvic drain	No pelvic drain is placed	No pelvic drain placed

Primary Outcome Measures

Name	Time	Method
Number of participants with pelvic sepsis	0-30 days postoperatively	anastomotic leak or pelvic collections clinically or radiologically detected

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital General Universitario Vall d´Hebron; 🇪🇸 Barcelona, Barcelona, Spain, Spain