- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01268748
Single Port Versus Four Ports Laparoscopic Cholecystectomy and Early Postoperative Pain (UMBI-CHOL)
Efficacy of Transumbilical Versus Standard Laparoscopic Cholecystectomy on Postoperative Pain
Study Overview
Status
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lars N Jorgensen, MD, DrMSc
- Phone Number: +45 35316441
- Email: larsnjorgensen@hotmail.com
Study Locations
-
-
-
Copenhagen NV, Denmark, DK-2400
- Recruiting
- Dept. of Surgery K, Bispebjerg Hospital
-
Contact:
- Lars N Jorgensen, MD, DrMSc
- Phone Number: +45 35316441
- Email: larsnjorgensen@hotmail.com
-
Principal Investigator:
- Lars N Jorgensen, MD, DrMSc
-
Sub-Investigator:
- Haytham Al-Tayar, MD
-
Gentofte, Denmark, DK-2920
- Recruiting
- Gentofte Hospital, University of Copenhagen
-
Contact:
- Jacob Rosenberg, MD, DrMSc
- Phone Number: +45 44883433
- Email: jaro@heh.regionh.dk
-
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:
- Thue Bisgaard, MD, DrMSc
- Phone Number: +45 47323224
- Email: thuebisgaard@tdcadsl.dk
-
Principal Investigator:
- Thue Bisgaard, MD, DrMSc
-
Sub-Investigator:
- Flemming Hjørne, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
Other: One port transumb. laparoscopic surgery
|
Patients allocated to this group will undergo laparoscopic cholecystectomy using only a transumbilical SILS port
Other Names:
|
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
Sponsor
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
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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