Randomized Trial of Early Versus Standard Drainage Removal After Pancreatic Resections

This study has been completed.
Sponsor:
Information provided by:
Universita di Verona
ClinicalTrials.gov Identifier:
NCT00931554
First received: May 28, 2009
Last updated: July 1, 2009
Last verified: July 2009
  Purpose

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.


Condition Intervention
Pancreaticoduodenectomy
Distal Pancreatectomy
Pancreatic Fistula
Abdominal Abscess
Procedure: Postoperative drain removal

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Early Versus Standard Drainage Removal After Pancreatic Resections: Results of a Prospective Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Universita di Verona:

Primary Outcome Measures:
  • Abdominal Complications [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • In-hospital stay [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Pulmonary complications [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Hospital readmission [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 114
Study Start Date: March 2007
Study Completion Date: April 2008
Arms Assigned Interventions
Active Comparator: Early drain removal
Drain removal in postoperative day 3
Procedure: Postoperative drain removal
removal of postoperative drainages at different time points (postoperative day 3 versus postoperative day 5)
Active Comparator: Standard drain removal
Drain removal on postoperative day 5
Procedure: Postoperative drain removal
removal of postoperative drainages at different time points (postoperative day 3 versus postoperative day 5)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00931554

Locations
Italy
General Surgery B, Policlinico G.B. Rossi
Verona, Italy, 37134
Sponsors and Collaborators
Universita di Verona
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Claudio Bassi MD, Professor of Surgery, Department of Surgical and Gastroenterological Sciences, University of Verona
ClinicalTrials.gov Identifier: NCT00931554     History of Changes
Other Study ID Numbers: DREN-01
Study First Received: May 28, 2009
Last Updated: July 1, 2009
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Abdominal Abscess
Pancreatic Fistula
Abscess
Digestive System Diseases
Digestive System Fistula
Fistula
Infection
Pancreatic Diseases
Pathological Conditions, Anatomical
Suppuration

ClinicalTrials.gov processed this record on October 21, 2014