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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00931554
Other study ID # DREN-01
Secondary ID
Status Completed
Phase N/A
First received May 28, 2009
Last updated July 1, 2009
Start date March 2007
Est. completion date April 2008

Study information

Verified date July 2009
Source Universita di Verona
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 114
Est. completion date April 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Procedure:
Postoperative drain removal
removal of postoperative drainages at different time points (postoperative day 3 versus postoperative day 5)

Locations

Country Name City State
Italy General Surgery B, Policlinico G.B. Rossi Verona

Sponsors (1)

Lead Sponsor Collaborator
Universita di Verona

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Abdominal Complications 1 month No
Secondary In-hospital stay 1 month No
Secondary Pulmonary complications 1 month No
Secondary Hospital readmission 1 month No
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