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Clinical Trial Details — Status: Unknown status

Administrative data

NCT number NCT01268748
Other study ID # H-3-2010-064
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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