Clinical Trial: Randomized Trial of Early Versus Standard Drainage Removal After Pancreatic Resections
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Early Versus Standard Drainage Removal After Pancreatic Resections: Results of a Prospective Randomized Clinical Trial
Brief 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.
Detailed Summary:
Sponsor: Universita di Verona
Current Primary Outcome: Abdominal Complications [ Time Frame: 1 month ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- In-hospital stay [ Time Frame: 1 month ]
- Pulmonary complications [ Time Frame: 1 month ]
- Hospital readmission [ Time Frame: 1 month ]
Original Secondary Outcome: Same as current
Information By: Universita di Verona
Dates:
Date Received: May 28, 2009
Date Started: March 2007
Date Completion:
Last Updated: July 1, 2009
Last Verified: July 2009
