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Randomized Trial of Early Versus Standard Drainage Removal After Pancreatic Resections

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00931554
First Posted: July 2, 2009
Last Update Posted: July 2, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Universita di Verona
  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: None (Open Label)
Primary Purpose: Prevention
Official Title: Early Versus Standard Drainage Removal After Pancreatic Resections: Results of a Prospective Randomized Clinical Trial

Further study details as provided by Universita di Verona:

Primary Outcome Measures:
  • Abdominal Complications [ Time Frame: 1 month ]

Secondary Outcome Measures:
  • In-hospital stay [ Time Frame: 1 month ]
  • Pulmonary complications [ Time Frame: 1 month ]
  • Hospital readmission [ Time Frame: 1 month ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00931554


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

Publications:
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
First Submitted: May 28, 2009
First Posted: July 2, 2009
Last Update Posted: July 2, 2009
Last Verified: July 2009

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