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

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Denmark
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 4 ports laparoscopic cholecystectomy
Procedure: Conventional laparoscopic procedure
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
Procedure: Experimental laparoscopic procedure
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bispebjerg Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Copenhagen
University Hospital, Gentofte, Copenhagen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2010

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2011

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 31, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 31, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-3-2010-064

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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