Early (4 Days) Versus Standard Drainage of the Abdominal Cavity After Pancreaticoduodenectomy

Summary

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.

Conditions

• Pancreatic Disease
• Pancreatic Neoplasms

Interventions

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.

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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens

  lead OTHER

Principal Investigators

• Jean-Marc REGIMBEAU, Pr · Centre Hospitalier Régional Universitaire d'Amiens

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-06-30

Primary Completion

2016-01-31

Completion

2016-01-31

Countries

• France

Study Locations