Pelvic Drain After Rectal Resection for Mid-low Rectal Cancer

Study Overview
=================
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.

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

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Procedure: Pelvic drain
* Other: No pelvic drain is placed


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pelvic drain<br>Placement of a pelvic drain | Procedure: Pelvic drain<br>* A pelvic drain is placed<br>|
| Experimental: No pelvic drain<br>No pelvic drain placed | Other: No pelvic drain is placed<br>* A pelvic drain is not placed<br>|

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 |