Randomized Trial of Early Versus Standard Drainage Removal After Pancreatic Resections

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pancreaticoduodenectomy Distal Pancreatectomy Pancreatic Fistula Abdominal Abscess

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Early drain removal

Drain removal in postoperative day 3

Group Type ACTIVE_COMPARATOR

Postoperative drain removal

Intervention Type PROCEDURE

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

Standard drain removal

Drain removal on postoperative day 5

Group Type ACTIVE_COMPARATOR

Postoperative drain removal

Intervention Type PROCEDURE

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

Interventions

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Postoperative drain removal

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No