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
Sponsor:
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
  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:
  • Versaport 12 mm
  • Versaport 5 mm
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Bispebjerg Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 31, 2014