Single Port Versus Four Ports Laparoscopic Cholecystectomy and Early Postoperative Pain (UMBI-CHOL)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Bispebjerg Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Bispebjerg Hospital
Collaborators:
University Hospital, Gentofte, Copenhagen
University of Copenhagen
Information provided by:
Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT01268748
First received: September 20, 2010
Last updated: December 30, 2010
Last verified: September 2010
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Purpose
This is a trial to evaluate if single port laparoscopic cholecystectomy causes less pain than conventional laparoscopic cholecystectomy.
| Condition | Intervention |
|---|---|
|
Pain, Postoperative Postoperative Nausea and Vomiting Postoperative Complications |
Procedure: Conventional laparoscopic procedure Procedure: Experimental laparoscopic procedure |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Efficacy of Transumbilical Versus Standard Laparoscopic Cholecystectomy on Postoperative Pain |
Resource links provided by NLM:
Further study details as provided by Bispebjerg Hospital:
Primary Outcome Measures:
- Pain scores on the Visual Analog Scale before surgery [ Time Frame: Before surgery ] [ Designated as safety issue: No ]
- Pain scores on the Visual Analog Scale 3 hours after surgery [ Time Frame: 3 hrs after surgery ] [ Designated as safety issue: No ]
- Pain scores on the Visual Analog Scale 1 day after surgery [ Time Frame: 1 day after surgery ] [ Designated as safety issue: No ]
- Pain scores on the Visual Analog Scale 2 days after surgery [ Time Frame: 2 days after surgery ] [ Designated as safety issue: No ]
- Pain scores on the Visual Analog Scale 3 days after surgery [ Time Frame: 3 days after surgery ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Nausea scores on a 4 point scale before surgery [ Time Frame: Before surgery ] [ Designated as safety issue: No ]The 4 point scale: none, light, moderate, and severe
- Nausea scores on a 4 point scale 3 hours after surgery [ Time Frame: 3 hours after surgery ] [ Designated as safety issue: No ]The 4 point scale: none, light, moderate, and severe
- Nausea scores on a 4 point scale 1 day surgery [ Time Frame: 1 day after surgery ] [ Designated as safety issue: No ]The 4 point scale: none, light, moderate, and severe
- Nausea scores on a 4 point scale 2 days after surgery [ Time Frame: 2 days after surgery ] [ Designated as safety issue: No ]The 4 point scale: none, light, moderate, and severe
- Nausea scores on a 4 point scale 3 days after surgery [ Time Frame: 3 days after surgery ] [ Designated as safety issue: No ]The 4 point scale: none, light, moderate, and severe
- Well being scores on the Visual Analog Scale before surgery [ Time Frame: Before surgery ] [ Designated as safety issue: No ]
- Well being scores on the Visual Analog Scale 3 hours after surgery [ Time Frame: 3 hours after surgery ] [ Designated as safety issue: No ]
- Well being scores on the Visual Analog Scale 1 day after surgery [ Time Frame: 1 day after surgery ] [ Designated as safety issue: No ]
- Well being scores on the Visual Analog Scale 2 days after surgery [ Time Frame: 2 days after surgery ] [ Designated as safety issue: No ]
- Well being scores on the Visual Analog Scale 3 days after surgery [ Time Frame: 3 days after surgery ] [ Designated as safety issue: No ]
- Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Within 30 days after surgery ] [ Designated as safety issue: Yes ]Adverse events include all complications related to surgery
- Patient-assessed cosmesis on the Visual Analog Scale 30 days after surgery [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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:
|
| 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 Name: SILS port
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01268748
Contacts
| Contact: Lars N Jorgensen, MD, DrMSc | +45 35316441 | larsnjorgensen@hotmail.com |
Locations
| Denmark | |
| Dept. of Surgery K, Bispebjerg Hospital | Recruiting |
| Copenhagen NV, Denmark, DK-2400 | |
| Contact: Lars N Jorgensen, MD, DrMSc +45 35316441 larsnjorgensen@hotmail.com | |
| Principal Investigator: Lars N Jorgensen, MD, DrMSc | |
| Sub-Investigator: Haytham Al-Tayar, MD | |
| Gentofte Hospital, University of Copenhagen | Recruiting |
| Gentofte, Denmark, DK-2920 | |
| Contact: Jacob Rosenberg, MD, DrMSc +45 44883433 jaro@heh.regionh.dk | |
| Principal Investigator: Jacob Rosenberg, MD, DrMSc | |
| Sub-Investigator: Sami Assaadzadeh, MD | |
| Dept. of Surgery, Koege Hospital, University of Copenhagen | Recruiting |
| Koege, Denmark, DK-4600 | |
| Contact: Thue Bisgaard, MD, DrMSc +45 47323224 thuebisgaard@tdcadsl.dk | |
| Principal Investigator: Thue Bisgaard, MD, DrMSc | |
| Sub-Investigator: Flemming Hjørne, MD | |
Sponsors and Collaborators
Bispebjerg Hospital
University Hospital, Gentofte, Copenhagen
University of Copenhagen
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 |
More Information
No publications provided
| Responsible Party: | Lars Nannestad Jorgensen MD, DrMSc, Professor, Dept. of Surgery K, Bispebjerg Hospital, University of Copenhagen, DK-2400 Copenhagen NV, Denmark |
| ClinicalTrials.gov Identifier: | NCT01268748 History of Changes |
| Other Study ID Numbers: | H-3-2010-064 |
| Study First Received: | September 20, 2010 |
| Last Updated: | December 30, 2010 |
| Health Authority: | Denmark: Danish Dataprotection Agency |
Keywords provided by Bispebjerg Hospital:
|
single site surgery laparoscopic surgery pain nausea |
Additional relevant MeSH terms:
|
Nausea Pain, Postoperative Postoperative Complications Vomiting Postoperative Nausea and Vomiting |
Signs and Symptoms, Digestive Signs and Symptoms Pathologic Processes Pain |
ClinicalTrials.gov processed this record on May 23, 2013