Single Port Versus Four Ports Laparoscopic Cholecystectomy and Early Postoperative Pain

Pain, Postoperative Clinical Trial

— UMBI-CHOL  

Official title:

Efficacy of Transumbilical Versus Standard Laparoscopic Cholecystectomy on Postoperative Pain

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01268748
• Other study ID #: H-3-2010-064
• Status: Unknown status
• Phase: N/A
• First received: September 20, 2010
• Last updated: December 30, 2010
• Start date: September 2010
• Est. completion date: June 2012

Study information

• Verified date: September 2010
• Source: Bispebjerg Hospital
• Contact: Lars N Jorgensen, MD, DrMSc
• Phone: +45 35316441
• Email: larsnjorgensen[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 120
• Est. completion date: June 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Conventional laparoscopic procedure
Patients allocated to this group will undergo laparoscopic cholecystectomy using two 12 mm ports and two 5 mm ports
• Experimental laparoscopic procedure
Patients allocated to this group will undergo laparoscopic cholecystectomy using only a transumbilical SILS port

Locations

Country	Name	City	State
Denmark	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

Sponsors (3)

Lead Sponsor	Collaborator
Bispebjerg Hospital	University Hospital, Gentofte, Copenhagen, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

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