Rectal Cancer
Conditions
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.
Interventions
PROCEDUREPelvic drain
A pelvic drain is placed
OTHERNo pelvic drain is placed
A pelvic drain is not placed
Sponsors
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The assessor will not know whether the patient received a drain or not
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with pelvic sepsis | 0-30 days postoperatively | anastomotic leak or pelvic collections clinically or radiologically detected |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of postperative stay | 0-30 days postoperatively or until discharge | Days of stay after surgery |
| Number of participants with postoperative ileus | 0-30 days postoperatively | Postoperative ileus |
| Management of pelvic sepsis | 0-30 days postoperatively | Type of management (medical, rediological, surgical) |
| Postoperative complications | 0-30 days postoperatively | Overall postoperative complications |
| CT scan or imaging needed | 0-30 days postoperatively | Necessity of performing unscheduled imaging tests |
| Diagnostic delay for a leak | 0-30 days postoperatively | Days between surgery and leak detection |
| 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 |
| Any complications associated with drain removal after surgery | up to 60 days after surgery | Safety of drain removal after surgery |
| Time to flatus and bowel movement | 0-30 days postoperatively | Days between surgery and flatus/faeces |
Countries
Spain
Contacts
Primary ContactEloy Espín-Basany
Outcome results
None listed