Randomized Trial of Early Versus Standard Drainage Removal After Pancreatic Resections
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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 |
- Abdominal Complications [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- 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 |
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
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:
|
Abscess Fistula Pancreatic Fistula Abdominal Abscess Suppuration Infection |
Inflammation Pathologic Processes Pathological Conditions, Anatomical Digestive System Fistula Digestive System Diseases Pancreatic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013