Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Early (4 Days) Versus Standard Drainage Removal of the Abdominal Cavity After Pancreaticoduodenectomy- - A Randomized Multicenter Study
Brief 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.


Options:
A: Arm Label: No Drains; Type: EXPERIMENTAL; Interventions: Procedure: No Drains | Arm Label: Drains; Type: EXPERIMENTAL; Interventions: Procedure: Drains | Intervention Type: PROCEDURE; Name: No Drains; Assigned to Arm(s): No Drains | Intervention Type: PROCEDURE; Name: Drains; Assigned to Arm(s): Drains
B: Arm Label: Standard drainage; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Standard drain removal | Arm Label: Short drainage; Type: EXPERIMENTAL; Interventions: Procedure: Drain removal at D4 | Intervention Type: PROCEDURE; Name: Drain removal at D4; Assigned to Arm(s): Short drainage | Intervention Type: PROCEDURE; Name: Standard drain removal; Assigned to Arm(s): Standard drainage
C: Arm Label: One-layer duct-to-mucosa Group; Type: EXPERIMENTAL; Interventions: Procedure: Modified one-layer duct-to-mucosa Pancreaticojejunostomy | Arm Label: Invagination Group; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Invagination pancreaticojejunostomy | Intervention Type: PROCEDURE; Name: Modified one-layer duct-to-mucosa Pancreaticojejunostomy; Assigned to Arm(s): One-layer duct-to-mucosa Group | Intervention Type: PROCEDURE; Name: Invagination pancreaticojejunostomy; Assigned to Arm(s): Invagination Group
D: Arm Label: Early drain removal; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Postoperative drain removal | Arm Label: Standard drain removal; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Postoperative drain removal | Intervention Type: PROCEDURE; Name: Postoperative drain removal; Assigned to Arm(s): Early drain removal, Standard drain removal

Answer: B