NCT04573621

Pelvic Drain After Rectal Resection for Mid-low Rectal Cancer

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 518 (estimated)
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
PROCEDURE	Pelvic drain	A pelvic drain is placed
OTHER	No pelvic drain is placed	A pelvic drain is not placed

Timeline

• Start date: 2020-10-01
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2020-10-05
• Last updated: 2020-10-05

Locations

1 site across 1 country: Spain