Early (4 Days) Versus Standard Drainage of the Abdominal Cavity After Pancreaticoduodenectomy
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|ClinicalTrials.gov Identifier: NCT01368094|
Recruitment Status : Completed
First Posted : June 7, 2011
Last Update Posted : May 3, 2016
Around two thousand pancreaticoduodenectomy (PD) are performed each year in France. This intervention is associated with a high rate of postoperative complications including:
- pancreatic fistulas (PF);
- surgical site infections (intra-abdominal abscess, wound infection);
- delayed gastric emptying (gastroparesis);
- and hemorrhage.
The incidence of SSI (superficial and deep) is about 35% and seems influenced by the prolonged intra-abdominal drainage. For several years, there has been a global trend to reduce the use of abdominal drainage after abdominal surgery. Several randomized clinical trials have shown that prophylactic drainage does not decrease the incidence of postoperative complications during elective hepatectomy, colectomy, and cholecystectomy and could increase the number of SSI. However, the role of prophylactic drainage after PD is so far unclear.
The aim of this prospective randomized multicenter study is to evaluate the influence of early (4 days) versus standard (10 to 15 days, depending on the staff clinical practice) drainage removal of the abdominal cavity after PD, on the rate of SSI.
Materials and Methods: The technique of PD is left at the discretion of the operator as well as the prescription of analogues of somatostatin. Drainage of the abdominal cavity is made of one or two round silicone close suction drains or open multichannel silicone drains placed in the vicinity of the pancreatic and biliary anastomosis. Shall be excluded patients operated on for chronic pancreatitis and patients who underwent preoperative radiotherapy. The 3rd postoperative day, a fistula is sought clinically, biologically and on CT-scanner images. In case of pancreatic fistula, the patient is excluded from randomization and drainage of the abdominal cavity is left in place depending on the different teams' practice. Patients without fistula are randomized to either drainage removal 4 days after surgery (D4) or standard drainage.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Disease Pancreatic Neoplasms||Procedure: Drain removal at D4 Procedure: Standard drain removal||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||141 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early (4 Days) Versus Standard Drainage Removal of the Abdominal Cavity After Pancreaticoduodenectomy- - A Randomized Multicenter Study|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
|Active Comparator: Standard drainage||
Procedure: Standard drain removal
If no pancreatic fistula (PF) or deep SSI is highlighted on the CT-scanner on day 3 postoperatively, the drain will be removed following the clinical routine practice of the surgical team that takes the patient in charge. The patient will leave the department when the surgeon deems necessary.
|Experimental: Short drainage||
Procedure: Drain removal at D4
If no pancreatic fistula (PF) or deep SSI is highlighted neither on the CT-scanner nor with biological analysis, on day 3 postoperatively, the drain will be removed on the 4th postoperative day, at the patient's bedside.
- Surgical Site Infection at D30 [ Time Frame: 30 days after surgical intervention ]
The outcome measure is the occurrence of surgical site infection (SSI) at D30, as defined by:
- surface SSI (wound abscess): infection of the skin, subcutaneous tissue or muscle, above the fascia, located at a surgical incision.
- deep SSI (intra-abdominal abscess) infection in operated tissues or in site of intervention (under the fascia).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01368094
|Amiens, Picardie, France, 80000|
|Centre Hospitalier de Beauvais|
|Beauvais, France, 60000|
|Centre Hospitalier Saint-Martin|
|Caen, France, 14050|
|Centre Hospitalier Régional Universitaire Claude Huriez|
|Lille, France, 59037|
|Centre Hospitalier Charles Nicolle|
|Rouen, France, 76 031|
|Principal Investigator:||Jean-Marc REGIMBEAU, Pr||Centre Hospitalier Régional Universitaire d'Amiens|