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

Vall d'Hebron University Hospital (HUVH)

Status: Unknown

Conditions: Rectal Cancer

Treatments: Procedure: Pelvic drain; Other: No pelvic drain is placed

Study type: Interventional

Funder types: Other

Identifiers

NCT04573621

GECO1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 518 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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518 participants in 2 patient groups

Pelvic drain

Active Comparator group

Description:

Placement of a pelvic drain

Treatment:

Procedure: Pelvic drain

No pelvic drain

Experimental group

Description:

No pelvic drain placed

Treatment:

Other: No pelvic drain is placed