CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 399 enrolled
Drug / intervention
No Drains +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01441492
NCT01441492N/ACompleted

A Randomized Prospective Multicenter Trial of Pancreas Resection With and Without Routine Intraperitoneal Drainage

Baylor College of Medicine·interventional·Posted Sep 27, 2011·Updated Aug 31, 2020

In Brief

A clinical study evaluating No Drains and Drains for Pancreas Tumor and Pancreatitis. Completed, enrolled 399 participants across 14 sites in 2 countries.

Detailed 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 days of surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 27, 2011
Enrollment StartSep 1, 2011
Primary CompletionSep 1, 2016
Study CompletionJul 25, 2017
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 14.8 years ago

Interventions

No Drainsprocedure

A closed-suction drain will not be placed near the transection margin at the time of surgery in the experimental group.

Drainsprocedure

A drain will be placed near the pancreatic transection margin at the time of surgery (standard of care).