Pancreas Resection With and Without Drains

Completed · Not applicable

Conditions studied: Pancreas Tumor, Pancreatitis

In brief

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.

Key facts

Study ID

NCT01441492

Run by

Baylor College of Medicine

People needed

399

Starts

2011-09-01

Expected to finish

2017-07-25

Last updated by the study team

2020-08-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Florida Health — Gainesville, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Indiana University - Purdue University Indianapolis — Indianapolis, Indiana, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Winthrop-University Hospital — Mineola, New York, United States
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Tennessee Health Science Center — Memphis, Tennessee, United States
• University of Texas Medical Branch — Galveston, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• University of Calgary — Calgary, Alberta, Canada
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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