Single Port Versus Four Ports Laparoscopic Cholecystectomy and Early Postoperative Pain

Not Applicable

• Conditions: Pain, Postoperative; Postoperative Nausea and Vomiting; Postoperative Complications
• Interventions: Procedure: Conventional laparoscopic procedure; Procedure: Experimental laparoscopic procedure

• Registration Number: NCT01268748
• Lead Sponsor: Bispebjerg Hospital

Brief 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.

Study Timeline

• Status Verified: 2010-09
• Study Start: 2010-09
• Study First Submitted: 2010-09-20
• Study First Submitted QC: 2010-12-30
• Last Update Submitted: 2010-12-30
• Study First Posted: 2010-12-31
• Last Update Posted: 2010-12-31
• Primary Completion: 2011-06
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4 ports laparoscopic cholecystectomy	Conventional laparoscopic procedure	-
One port transumb. laparoscopic surgery	Experimental laparoscopic procedure	-

Primary Outcome Measures

Name	Time	Method
Pain scores on the Visual Analog Scale before surgery	Before surgery
Pain scores on the Visual Analog Scale 3 hours after surgery	3 hrs after surgery
Pain scores on the Visual Analog Scale 1 day after surgery	1 day after surgery
Pain scores on the Visual Analog Scale 2 days after surgery	2 days after surgery
Pain scores on the Visual Analog Scale 3 days after surgery	3 days after surgery

Secondary Outcome Measures

Name	Time	Method
Nausea scores on a 4 point scale before surgery	Before surgery	The 4 point scale: none, light, moderate, and severe
Nausea scores on a 4 point scale 3 hours after surgery	3 hours after surgery	The 4 point scale: none, light, moderate, and severe
Nausea scores on a 4 point scale 1 day surgery	1 day after surgery	The 4 point scale: none, light, moderate, and severe
Nausea scores on a 4 point scale 2 days after surgery	2 days after surgery	The 4 point scale: none, light, moderate, and severe
Nausea scores on a 4 point scale 3 days after surgery	3 days after surgery	The 4 point scale: none, light, moderate, and severe
Well being scores on the Visual Analog Scale before surgery	Before surgery
Well being scores on the Visual Analog Scale 3 hours after surgery	3 hours after surgery
Well being scores on the Visual Analog Scale 1 day after surgery	1 day after surgery
Well being scores on the Visual Analog Scale 2 days after surgery	2 days after surgery
Well being scores on the Visual Analog Scale 3 days after surgery	3 days after surgery
Number of participants with adverse events as a measure of safety and tolerability	Within 30 days after surgery	Adverse events include all complications related to surgery
Patient-assessed cosmesis on the Visual Analog Scale 30 days after surgery	30 days after surgery

Trial Locations

Locations (3)

Dept. of Surgery K, Bispebjerg Hospital; 🇩🇰 Copenhagen NV, Denmark

Gentofte Hospital, University of Copenhagen; 🇩🇰 Gentofte, Denmark

Dept. of Surgery, Koege Hospital, University of Copenhagen; 🇩🇰 Koege, Denmark