Pelvic Drain After Rectal Resection for Mid-low Rectal Cancer
NCT ID: NCT04573621
Last Updated: 2020-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
518 participants
INTERVENTIONAL
2020-10-31
2022-09-30
Brief Summary
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Detailed Description
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* pelvic drain
* no pelvic drain. Patients will be followed-up to assess the rates of anastomotic leaks, pelvic sepsis and secondary outcomes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Pelvic drain
Placement of a pelvic drain
Pelvic drain
A pelvic drain is placed
No pelvic drain
No pelvic drain placed
No pelvic drain is placed
A pelvic drain is not placed
Interventions
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Pelvic drain
A pelvic drain is placed
No pelvic drain is placed
A pelvic drain is not placed
Eligibility Criteria
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Inclusion Criteria
* Mid or low rectal cancer
* Anastomosis below the peritoneal reflection
* Total mesorectal excision (TME)
* Capability to understand the study
* Informed consent
Exclusion Criteria
* Chronic kidney failure or hepatic failure, immunodepression, malnoutrition
* Life expectancy \< 6 months
* Partial mesorectal excision
* Abdominoperineal excision
* Multivisceral resections
* Emergency surgery
18 Years
ALL
No
Sponsors
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Hospital Universitari Vall d'Hebron Research Institute
OTHER
Responsible Party
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Locations
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Hospital General Universitario Vall d´Hebron
Barcelona, Barcelona, Spain, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GECO1
Identifier Type: -
Identifier Source: org_study_id
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