Pancreas Resection With and Without Drains
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 days of surgery.
Procedure: No Drains
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Prospective Multicenter Trial of Pancreas Resection With and Without Routine Intraperitoneal Drainage|
- The primary outcome measure is the incidence of > grade I complications. [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
- Frequency of specific complications [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
- Severity of complications [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]The mean complication severity grade for each study group will be compared
- Mortality [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Experimental: No Drains
Patients who will not receive intraperitoneal drainage following pancreas resection.
Procedure: No Drains
A closed-suction drain will not be placed near the transection margin at the time of surgery in the experimental group.
Patients who will receive drains, the standard of care treatment, following pancreas resection.
A drain will be placed near the pancreatic transection margin at the time of surgery (standard of care).
Other Name: The specific brand of drain is not contolled.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01441492
|Contact: William E Fisher, M.D.||email@example.com|
|Contact: Gerardo Buentello, M.D.||firstname.lastname@example.org|
|United States, Texas|
|Baylor College of Medicine||Recruiting|
|Houston, Texas, United States, 77338|
|Contact: William E Fisher, MD 832-355-1490|
|Contact: Gerardo Buentello, MD 713-798-5210 email@example.com|
|Principal Investigator: William E Fisher, MD|
|Principal Investigator:||William E Fisher, M.D.||Baylor College of Medicine|