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

December 30, 2010 updated by: Bispebjerg Hospital

Efficacy of Transumbilical Versus Standard Laparoscopic Cholecystectomy on Postoperative Pain

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

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Copenhagen NV, Denmark, DK-2400
        • Recruiting
        • Dept. of Surgery K, Bispebjerg Hospital
        • Contact:
        • Principal Investigator:
          • Lars N Jorgensen, MD, DrMSc
        • Sub-Investigator:
          • Haytham Al-Tayar, MD
      • Gentofte, Denmark, DK-2920
        • Recruiting
        • Gentofte Hospital, University of Copenhagen
        • Contact:
        • Principal Investigator:
          • Jacob Rosenberg, MD, DrMSc
        • Sub-Investigator:
          • Sami Assaadzadeh, MD
      • Koege, Denmark, DK-4600
        • Recruiting
        • Dept. of Surgery, Koege Hospital, University of Copenhagen
        • Contact:
        • Principal Investigator:
          • Thue Bisgaard, MD, DrMSc
        • Sub-Investigator:
          • Flemming Hjørne, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 4 ports laparoscopic cholecystectomy
Patients allocated to this group will undergo laparoscopic cholecystectomy using two 12 mm ports and two 5 mm ports
Other Names:
  • Versaport 12 mm
  • Versaport 5 mm
Other: One port transumb. laparoscopic surgery
Patients allocated to this group will undergo laparoscopic cholecystectomy using only a transumbilical SILS port
Other Names:
  • SILS port

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain scores on the Visual Analog Scale before surgery
Time Frame: Before surgery
Before surgery
Pain scores on the Visual Analog Scale 3 hours after surgery
Time Frame: 3 hrs after surgery
3 hrs after surgery
Pain scores on the Visual Analog Scale 1 day after surgery
Time Frame: 1 day after surgery
1 day after surgery
Pain scores on the Visual Analog Scale 2 days after surgery
Time Frame: 2 days after surgery
2 days after surgery
Pain scores on the Visual Analog Scale 3 days after surgery
Time Frame: 3 days after surgery
3 days after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Haytham Al-Tayar, MD, Dept. of Surgery, Bispebjerg Hospital, University of Copenhagen
  • Principal Investigator: Sami Assaadzadeh, MD, Dept. of Surgery, Gentofte Hospital, University of Copenhagen
  • Principal Investigator: Jacob Rosenberg, MD, DrMSc, Dept. of Surgery, Herlev Hospital, University of Copenhagen
  • Principal Investigator: Flemming Hjørne, MD, Dept. of Surgery, Køge Hospital, University of Copenhagen
  • Principal Investigator: Thue Bisgaard, MD, DrMSc, Dept. of Surgery, Køge Hospital, University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Anticipated)

June 1, 2011

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

September 20, 2010

First Submitted That Met QC Criteria

December 30, 2010

First Posted (Estimate)

December 31, 2010

Study Record Updates

Last Update Posted (Estimate)

December 31, 2010

Last Update Submitted That Met QC Criteria

December 30, 2010

Last Verified

September 1, 2010

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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