Randomized Trial of Early Versus Standard Drainage Removal After Pancreatic Resections

Not Applicable

Completed

• Conditions: Pancreaticoduodenectomy; Distal Pancreatectomy; Pancreatic Fistula; Abdominal Abscess
• Interventions: Procedure: Postoperative drain removal

• Registration Number: NCT00931554
• Lead Sponsor: Universita di Verona

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 Description

Not available

Study Timeline

• Study Start: 2007-03
• Study Completion: 2008-04
• Study First Submitted: 2009-05-28
• Status Verified: 2009-07
• Study First Submitted QC: 2009-07-01
• Last Update Submitted: 2009-07-01
• Study First Posted: 2009-07-02
• Last Update Posted: 2009-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

• Patients undergone either pancreaticoduodenectomy (reconstruction by pancreaticojejunostomy) or distal pancreatectomy with an amylase value in drains on postoperative day 1 less than 5000 IU/L

Exclusion Criteria

• Pancreaticoduodenectomy reconstructed with pancreaticogastrostomy
• Clinical suspect of postoperative haemorrhage within 72hours after the operation
• Clinical suspect of biliary fistula
• Fluid collection greater than 3cm at an ultrasound carried out on postoperative day 3

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early drain removal	Postoperative drain removal	Drain removal in postoperative day 3
Standard drain removal	Postoperative drain removal	Drain removal on postoperative day 5

Primary Outcome Measures

Name	Time	Method
Abdominal Complications	1 month

Secondary Outcome Measures

Name	Time	Method
In-hospital stay	1 month
Pulmonary complications	1 month
Hospital readmission	1 month

Trial Locations

Locations (1)

General Surgery B, Policlinico G.B. Rossi; 🇮🇹 Verona, Italy