NCT01268748

Single Port Versus Four Ports Laparoscopic Cholecystectomy and Early Postoperative Pain

Efficacy of Transumbilical Versus Standard Laparoscopic Cholecystectomy on Postoperative Pain

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Bispebjerg Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Pain, Postoperative
• Postoperative Nausea and Vomiting
• Postoperative Complications

Interventions

Type	Name	Description
PROCEDURE	Conventional laparoscopic procedure	Patients allocated to this group will undergo laparoscopic cholecystectomy using two 12 mm ports and two 5 mm ports
PROCEDURE	Experimental laparoscopic procedure	Patients allocated to this group will undergo laparoscopic cholecystectomy using only a transumbilical SILS port

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-06-01
• Completion: 2012-06-01
• First posted: 2010-12-31
• Last updated: 2010-12-31

Locations

3 sites across 1 country: Denmark