Pelvic Drain After Rectal Resection for Mid-low Rectal Cancer
GECO1
1 other identifier
interventional
518
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedFirst Posted
Study publicly available on registry
October 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedOctober 5, 2020
September 1, 2020
1.9 years
September 24, 2020
October 1, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with pelvic sepsis
anastomotic leak or pelvic collections clinically or radiologically detected
0-30 days postoperatively
Secondary Outcomes (12)
Management of pelvic sepsis
0-30 days postoperatively
Postoperative complications
0-30 days postoperatively
CT scan or imaging needed
0-30 days postoperatively
Number of participants with postoperative ileus
0-30 days postoperatively
Diagnostic delay for a leak
0-30 days postoperatively
- +7 more secondary outcomes
Study Arms (2)
Pelvic drain
ACTIVE COMPARATORPlacement of a pelvic drain
No pelvic drain
EXPERIMENTALNo pelvic drain placed
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- For women, pregnancy
- Chronic kidney failure or hepatic failure, immunodepression, malnoutrition
- Life expectancy \< 6 months
- Partial mesorectal excision
- Abdominoperineal excision
- Multivisceral resections
- Emergency surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital General Universitario Vall d´Hebron
Barcelona, Barcelona, Spain, 08035, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The assessor will not know whether the patient received a drain or not
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2020
First Posted
October 5, 2020
Study Start
October 1, 2020
Primary Completion
September 1, 2022
Study Completion
September 1, 2022
Last Updated
October 5, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share