CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 114 enrolled
Drug / intervention
Postoperative drain removalprocedure
Likely dose
Not stated in record
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Search/NCT00931554
NCT00931554N/ACompleted

Early Versus Standard Drainage Removal After Pancreatic Resections: Results of a Prospective Randomized Clinical Trial

Universita di Verona·interventional·Posted Jul 2, 2009·Updated Jul 2, 2009

In Brief

A clinical study evaluating Postoperative drain removal for Pancreaticoduodenectomy and 3 related conditions. Completed, enrolled 114 participants across 1 site.

Detailed Summary

Despite a substantial decrease in postoperative mortality, morbidity after pancreatic resections is still high, even at high-volume centers. It has been recently suggested that early removal of postoperative drainages is associated to a decreased rate of intra-abdominal complications, with particular regard to pancreatic fistula. Furthermore, our research group demonstrated that measuring amylase value in drainages (AVD) on postoperative day 1 plays a cardinal role in predicting the developement of abdominal complications, including pancreatic fistula. In particular, patients with an AVD lower than 5000 IU/L in postoperative day 1 were considered at low risk of fistula. Therefore, the investigators designed a randomized prospective trial on early (postoperative day 3) versus standard (postoperative day 5) drainages removal after pancreatic resections in patients at low risk of developing pancreatic fistula (AVD \< 5000 IU/L in postoperative day 1) to test whether drainages "per se" influence postoperative complication rates and to eventually validate a fast-track policy in pancreatic resections.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 2, 2009
Enrollment StartMar 1, 2007
Study CompletionApr 1, 2008
TodayJul 2, 2026
Posted 17 years ago

Interventions

Postoperative drain removalprocedure

removal of postoperative drainages at different time points (postoperative day 3 versus postoperative day 5)