Randomized Trial of Early Versus Standard Drainage Removal After Pancreatic Resections
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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)
|
Outcome Measures
Primary Outcome Measures
- Abdominal Complications [1 month]
Secondary Outcome Measures
- In-hospital stay [1 month]
- Pulmonary complications [1 month]
- Hospital readmission [1 month]
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | General Surgery B, Policlinico G.B. Rossi | Verona | Italy | 37134 |
Sponsors and Collaborators
- Universita di Verona
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- DREN-01