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

Pain, Postoperative Clinical Trial

Official title: Efficacy of Transumbilical Versus Standard Laparoscopic Cholecystectomy on Postoperative Pain

Status Unknown status

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT01268748
• Study type: Interventional
• Source: Bispebjerg Hospital
• Contact: Lars N Jorgensen, MD, DrMSc
• Phone: +45 35316441
• Email: larsnjorgensen@hotmail.com
• Status: Unknown status
• Phase: N/A
• Start date: September 2010
• Completion date: June 2012