Single Port Versus Four Ports Laparoscopic Cholecystectomy and Early Postoperative Pain (UMBI-CHOL)

Bispebjerg Hospital

Status: Unknown

Conditions: Postoperative Complications; Postoperative Nausea and Vomiting; Pain, Postoperative

Treatments: Procedure: Conventional laparoscopic procedure; Procedure: Experimental laparoscopic procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT01268748

H-3-2010-064

Details and patient eligibility

About

This is a trial to evaluate if single port laparoscopic cholecystectomy causes less pain than conventional laparoscopic cholecystectomy.

Full description

This study is a randomized, two-arm, double-blinded three-center trial to compare single-port transumbilical laparoscopic cholecystectomy with conventional 4-port laparoscopic cholecystectomy. 120 patients are included with a 1:1 randomization. Three centers participate in the trial.

Inclusion criteria: Female patients, ASA I-III, age between 18 and 75 years, elective laparoscopic cholecystectomy because of biliary pain or recent uncomplicated biliary pancreatitis.

Exclusion criteria: Expected poor compliance, history of cholecystitis or severe pancreatitis, previous open upper abdominal surgery, pregnancy or lactation, preoperative chronic pain or conversion from laparoscopic to open surgery.

Pain and nausea is measured on VAS before the operation and 3 hrs, 1 day, 2 days and 3 days after the operation.

Cosmesis is evaluated after 28 days.

Patients are telephone-interviewed after 12 months and asked about port hernia formation. If hernia is suspected patients are called in for an abdominal ultrasonography.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ASA I-III
• Planned elective laparoscopic cholecystectomy because of biliary pain or uncomplicated biliary pancreatitis

Exclusion criteria

• Expected poor compliance
• History of cholecystitis or severe pancreatitis
• Earlier open upper abdominal surgery, pregnancy or lactation, chronic pain or conversion to open surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

4 ports laparoscopic cholecystectomy

Other group

Treatment:

Procedure: Conventional laparoscopic procedure

One port transumb. laparoscopic surgery

Other group

Treatment:

Procedure: Experimental laparoscopic procedure