Drain After Elective Laparoscopic Cholecystectomy

University of Roma La Sapienza

Status: Completed

Conditions: Cholelithiasis

Treatments: Procedure: no drain; Procedure: drain positioned; Procedure: drain not positioned

Study type: Interventional

Funder types: Other

Identifiers

NCT00986544

Pic63

Details and patient eligibility

About

The trial aims to assess the value of drains in elective laparoscopic cholecystectomy.

Full description

After laparoscopic gallbladder removal patients are randomized to have a suction drain positioned in the subhepatic space or to have a sham drain in the subhepatic space. The primary outcome measure will be the presence of subhepatic fluid collection at ultrasonographic examination on the first postoperative day. Secondary outcome measures will be postoperative abdominal and shoulder tip pain, use of analgesics, nausea, vomiting and morbidity

Enrollment: 106 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• elective laparoscopic cholecystectomy

Exclusion criteria

• acute cholecystitis, cholangitis, or pancreatitis
• no contraindication for the laparoscopic
• no other additional procedure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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106 participants in 2 patient groups

Absence of drain

Sham Comparator group

Treatment:

Procedure: no drain

Procedure: drain not positioned

Drain

Active Comparator group

Description:

drain positioned in the subhepatic space after laparoscopic cholecystectomy

Treatment:

Procedure: drain positioned