Status:
COMPLETED
Pancreas Resection With and Without Drains
Lead Sponsor:
Baylor College of Medicine
Conditions:
Pancreas Tumor
Pancreatitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This randomized prospective trial is designed to test the hypothesis that pancreatectomy without routine intraperitoneal drainage does not increase the severity or frequency of complications within 60...
Detailed Description
The rate of pancreatic fistula after pancreas resection is about 10% and surgeons have traditionally placed drains near the pancreatic anastomosis to control this potentially very serious complication...
Eligibility Criteria
Inclusion
- The subject has a surgical indication for distal pancreatectomy.
- In the opinion of the surgeon, the subject has no medical contraindications to pancreatectomy.
- At least 18 years of age.
- The subject is willing to consent to randomization to the intraperitoneal drain vs. no drain group.
- The subject is willing to comply with 90-day follow-up and answer quality-of-life questionnaires per protocol.
Exclusion
- The subject does not have a surgical indication for distal pancreatectomy.
- In the opinion of the surgeon, the subject has medical contraindications to pancreatectomy.
- Less than 18 years of age.
- The subject is not willing to consent to randomization to the intraperitoneal drain vs. no drain group.
- The subject is not willing to comply with 90-day follow-up and answer quality-of-life questionnaires per protocol.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2017
Estimated Enrollment :
399 Patients enrolled
Trial Details
Trial ID
NCT01441492
Start Date
September 1 2011
End Date
July 25 2017
Last Update
August 31 2020
Active Locations (14)
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1
University of Florida Health
Gainesville, Florida, United States, 32611
2
University of South Florida
Tampa, Florida, United States, 33606
3
Indiana University - Purdue University Indianapolis
Indianapolis, Indiana, United States, 46202
4
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198