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Randomized Trial of Early Versus Standard Drainage Removal After Pancreatic Resections

Primary Purpose

Pancreaticoduodenectomy, Distal Pancreatectomy, Pancreatic Fistula

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Postoperative drain removal
Sponsored by
Universita di Verona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pancreaticoduodenectomy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • General Surgery B, Policlinico G.B. Rossi

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Early drain removal

Standard drain removal

Arm Description

Drain removal in postoperative day 3

Drain removal on postoperative day 5

Outcomes

Primary Outcome Measures

Abdominal Complications

Secondary Outcome Measures

In-hospital stay
Pulmonary complications
Hospital readmission

Full Information

First Posted
May 28, 2009
Last Updated
July 1, 2009
Sponsor
Universita di Verona
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1. Study Identification

Unique Protocol Identification Number
NCT00931554
Brief Title
Randomized Trial of Early Versus Standard Drainage Removal After Pancreatic Resections
Official Title
Early Versus Standard Drainage Removal After Pancreatic Resections: Results of a Prospective Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Universita di Verona

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreaticoduodenectomy, Distal Pancreatectomy, Pancreatic Fistula, Abdominal Abscess

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early drain removal
Arm Type
Active Comparator
Arm Description
Drain removal in postoperative day 3
Arm Title
Standard drain removal
Arm Type
Active Comparator
Arm Description
Drain removal on postoperative day 5
Intervention Type
Procedure
Intervention Name(s)
Postoperative drain removal
Intervention Description
removal of postoperative drainages at different time points (postoperative day 3 versus postoperative day 5)
Primary Outcome Measure Information:
Title
Abdominal Complications
Time Frame
1 month
Secondary Outcome Measure Information:
Title
In-hospital stay
Time Frame
1 month
Title
Pulmonary complications
Time Frame
1 month
Title
Hospital readmission
Time Frame
1 month

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
General Surgery B, Policlinico G.B. Rossi
City
Verona
ZIP/Postal Code
37134
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
17667507
Citation
Molinari E, Bassi C, Salvia R, Butturini G, Crippa S, Talamini G, Falconi M, Pederzoli P. Amylase value in drains after pancreatic resection as predictive factor of postoperative pancreatic fistula: results of a prospective study in 137 patients. Ann Surg. 2007 Aug;246(2):281-7. doi: 10.1097/SLA.0b013e3180caa42f.
Results Reference
background
PubMed Identifier
16794381
Citation
Kawai M, Tani M, Terasawa H, Ina S, Hirono S, Nishioka R, Miyazawa M, Uchiyama K, Yamaue H. Early removal of prophylactic drains reduces the risk of intra-abdominal infections in patients with pancreatic head resection: prospective study for 104 consecutive patients. Ann Surg. 2006 Jul;244(1):1-7. doi: 10.1097/01.sla.0000218077.14035.a6.
Results Reference
background
PubMed Identifier
20622661
Citation
Bassi C, Molinari E, Malleo G, Crippa S, Butturini G, Salvia R, Talamini G, Pederzoli P. Early versus late drain removal after standard pancreatic resections: results of a prospective randomized trial. Ann Surg. 2010 Aug;252(2):207-14. doi: 10.1097/SLA.0b013e3181e61e88.
Results Reference
derived

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Randomized Trial of Early Versus Standard Drainage Removal After Pancreatic Resections

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