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OpenTrials
Completed

NCT Number: NCT00931554

Randomized Trial of Early Versus Standard Drainage Removal After Pancreatic Resections

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Surgery B, Policlinico G.B. Rossi

Verona, 37134, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Postoperative drain removal

Procedure

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

Primary outcomes

  1. Abdominal Complications

    Time frame: 1 month

Secondary outcomes

  1. In-hospital stay

    Time frame: 1 month

  2. Pulmonary complications

    Time frame: 1 month

  3. Hospital readmission

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Universita di Verona

Other

Registry information

Official study title

Early Versus Standard Drainage Removal After Pancreatic Resections: Results of a Prospective Randomized Clinical Trial

Important dates

Study start
2007
Study completion
2008
First posted
Jul 2, 2009
Registry last updated
Jul 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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