NCT00931554

Randomized Trial of Early Versus Standard Drainage Removal After Pancreatic Resections

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Universita di Verona · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreaticoduodenectomy
• Distal Pancreatectomy
• Pancreatic Fistula
• Abdominal Abscess

Interventions

Type	Name	Description
PROCEDURE	Postoperative drain removal	removal of postoperative drainages at different time points (postoperative day 3 versus postoperative day 5)

Timeline

• Start date: 2007-03-01
• Completion: 2008-04-01
• First posted: 2009-07-02
• Last updated: 2009-07-02

Locations

1 site across 1 country: Italy