Randomized Trial of Early Versus Standard Drainage Removal After Pancreatic Resections

NCT00931554 | Completed

• 1 other identifier: DREN-01
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreaticoduodenectomy; Distal Pancreatectomy; Pancreatic Fistula; Abdominal Abscess

Outcome Measures

Primary Outcomes (1)

• Abdominal Complications

  1 month

Secondary Outcomes (3)

• In-hospital stay

  1 month

• Pulmonary complications

  1 month

• Hospital readmission

  1 month

Study Arms (2)

Early drain removal

ACTIVE COMPARATOR

Drain removal in postoperative day 3

Procedure: Postoperative drain removal

Standard drain removal

ACTIVE COMPARATOR

Drain removal on postoperative day 5

Procedure: Postoperative drain removal

Interventions

Postoperative drain removal PROCEDURE

removal of postoperative drainages at different time points (postoperative day 3 versus postoperative day 5)

Early drain removal; Standard drain removal

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

General Surgery B, Policlinico G.B. Rossi

Verona, 37134, Italy

Location

Related Publications (3)

• 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. doi: 10.1097/SLA.0b013e3180caa42f.

  PMID: 17667507 BACKGROUND

• 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. doi: 10.1097/01.sla.0000218077.14035.a6.

  PMID: 16794381 BACKGROUND

• Bassi C, Molinari E, Malleo G, Crippa S, Butturini G, Salvia R, Talamini G, Pederzoli P. Early versus late drain removal after standard pancreatic resections: results of a prospective randomized trial. Ann Surg. 2010 Aug;252(2):207-14. doi: 10.1097/SLA.0b013e3181e61e88.

  PMID: 20622661 DERIVED

MeSH Terms

Conditions

Pancreatic Fistula; Abdominal Abscess

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Pancreatic Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Abscess; Suppuration; Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 28, 2009
• First Posted: July 2, 2009
• Study Start: March 1, 2007
• Study Completion: April 1, 2008
• Last Updated: July 2, 2009

Record last verified: 2009-07

Locations

IT (1)