The Role of Transanal Tube Drainage as A Mean of Prevention of Anastomotic Leakage Anastomotic Leakage
1 other identifier
interventional
100
1 country
1
Brief Summary
Anastomotic leakage (AL) is considered the commonest major complication after surgery for rectal cancer. Transanal tube drainage role in the prevention of AL is still debatable.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2017
CompletedFirst Submitted
Initial submission to the registry
October 24, 2017
CompletedFirst Posted
Study publicly available on registry
October 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedOctober 30, 2017
October 1, 2017
2 months
October 24, 2017
October 24, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Anastomotic leakage
Prevention
30 days
Study Arms (2)
TD
EXPERIMENTALNTD
NO INTERVENTIONInterventions
A de-Pezzer catheter was placed transanally after the creation of the anastomosis, secured to the buttocks, and connected to a urine bag to allow monitoring the amount and the color of the drainage. The catheter was removed on the 3rd day postoperative if the volume collected was insignificant.
Eligibility Criteria
You may qualify if:
- Low or ultralow anterior resection with primary anastomosis for biopsy-proven primary rectal cancer
You may not qualify if:
- No anastomosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Policlinico Tor Vergata Hospital
Rome, RM, 00133, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 24, 2017
First Posted
October 30, 2017
Study Start
October 1, 2017
Primary Completion
December 1, 2017
Study Completion
June 1, 2018
Last Updated
October 30, 2017
Record last verified: 2017-10