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Single Port Versus Four Ports Laparoscopic Cholecystectomy and Early Postoperative Pain (UMBI-CHOL)

Primary Purpose

Pain, Postoperative, Postoperative Nausea and Vomiting, Postoperative Complications

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Conventional laparoscopic procedure
Experimental laparoscopic procedure
Sponsored by
Bispebjerg Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring single site surgery, laparoscopic surgery, pain, nausea

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Dept. of Surgery K, Bispebjerg HospitalRecruiting
  • Gentofte Hospital, University of CopenhagenRecruiting
  • Dept. of Surgery, Koege Hospital, University of CopenhagenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

4 ports laparoscopic cholecystectomy

One port transumb. laparoscopic surgery

Arm Description

Outcomes

Primary Outcome Measures

Pain scores on the Visual Analog Scale before surgery
Pain scores on the Visual Analog Scale 3 hours after surgery
Pain scores on the Visual Analog Scale 1 day after surgery
Pain scores on the Visual Analog Scale 2 days after surgery
Pain scores on the Visual Analog Scale 3 days after surgery

Secondary Outcome Measures

Nausea scores on a 4 point scale before surgery
The 4 point scale: none, light, moderate, and severe
Nausea scores on a 4 point scale 3 hours after surgery
The 4 point scale: none, light, moderate, and severe
Nausea scores on a 4 point scale 1 day surgery
The 4 point scale: none, light, moderate, and severe
Nausea scores on a 4 point scale 2 days after surgery
The 4 point scale: none, light, moderate, and severe
Nausea scores on a 4 point scale 3 days after surgery
The 4 point scale: none, light, moderate, and severe
Well being scores on the Visual Analog Scale before surgery
Well being scores on the Visual Analog Scale 3 hours after surgery
Well being scores on the Visual Analog Scale 1 day after surgery
Well being scores on the Visual Analog Scale 2 days after surgery
Well being scores on the Visual Analog Scale 3 days after surgery
Number of participants with adverse events as a measure of safety and tolerability
Adverse events include all complications related to surgery
Patient-assessed cosmesis on the Visual Analog Scale 30 days after surgery

Full Information

First Posted
September 20, 2010
Last Updated
December 30, 2010
Sponsor
Bispebjerg Hospital
Collaborators
University Hospital, Gentofte, Copenhagen, University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT01268748
Brief Title
Single Port Versus Four Ports Laparoscopic Cholecystectomy and Early Postoperative Pain
Acronym
UMBI-CHOL
Official Title
Efficacy of Transumbilical Versus Standard Laparoscopic Cholecystectomy on Postoperative Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
June 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Bispebjerg Hospital
Collaborators
University Hospital, Gentofte, Copenhagen, University of Copenhagen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a trial to evaluate if single port laparoscopic cholecystectomy causes less pain than conventional laparoscopic cholecystectomy.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Postoperative Nausea and Vomiting, Postoperative Complications
Keywords
single site surgery, laparoscopic surgery, pain, nausea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
4 ports laparoscopic cholecystectomy
Arm Type
Other
Arm Title
One port transumb. laparoscopic surgery
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Conventional laparoscopic procedure
Other Intervention Name(s)
Versaport 12 mm, Versaport 5 mm
Intervention Description
Patients allocated to this group will undergo laparoscopic cholecystectomy using two 12 mm ports and two 5 mm ports
Intervention Type
Procedure
Intervention Name(s)
Experimental laparoscopic procedure
Other Intervention Name(s)
SILS port
Intervention Description
Patients allocated to this group will undergo laparoscopic cholecystectomy using only a transumbilical SILS port
Primary Outcome Measure Information:
Title
Pain scores on the Visual Analog Scale before surgery
Time Frame
Before surgery
Title
Pain scores on the Visual Analog Scale 3 hours after surgery
Time Frame
3 hrs after surgery
Title
Pain scores on the Visual Analog Scale 1 day after surgery
Time Frame
1 day after surgery
Title
Pain scores on the Visual Analog Scale 2 days after surgery
Time Frame
2 days after surgery
Title
Pain scores on the Visual Analog Scale 3 days after surgery
Time Frame
3 days after surgery
Secondary Outcome Measure Information:
Title
Nausea scores on a 4 point scale before surgery
Description
The 4 point scale: none, light, moderate, and severe
Time Frame
Before surgery
Title
Nausea scores on a 4 point scale 3 hours after surgery
Description
The 4 point scale: none, light, moderate, and severe
Time Frame
3 hours after surgery
Title
Nausea scores on a 4 point scale 1 day surgery
Description
The 4 point scale: none, light, moderate, and severe
Time Frame
1 day after surgery
Title
Nausea scores on a 4 point scale 2 days after surgery
Description
The 4 point scale: none, light, moderate, and severe
Time Frame
2 days after surgery
Title
Nausea scores on a 4 point scale 3 days after surgery
Description
The 4 point scale: none, light, moderate, and severe
Time Frame
3 days after surgery
Title
Well being scores on the Visual Analog Scale before surgery
Time Frame
Before surgery
Title
Well being scores on the Visual Analog Scale 3 hours after surgery
Time Frame
3 hours after surgery
Title
Well being scores on the Visual Analog Scale 1 day after surgery
Time Frame
1 day after surgery
Title
Well being scores on the Visual Analog Scale 2 days after surgery
Time Frame
2 days after surgery
Title
Well being scores on the Visual Analog Scale 3 days after surgery
Time Frame
3 days after surgery
Title
Number of participants with adverse events as a measure of safety and tolerability
Description
Adverse events include all complications related to surgery
Time Frame
Within 30 days after surgery
Title
Patient-assessed cosmesis on the Visual Analog Scale 30 days after surgery
Time Frame
30 days after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lars N Jorgensen, MD, DrMSc
Phone
+45 35316441
Email
larsnjorgensen@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haytham Al-Tayar, MD
Organizational Affiliation
Dept. of Surgery, Bispebjerg Hospital, University of Copenhagen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sami Assaadzadeh, MD
Organizational Affiliation
Dept. of Surgery, Gentofte Hospital, University of Copenhagen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jacob Rosenberg, MD, DrMSc
Organizational Affiliation
Dept. of Surgery, Herlev Hospital, University of Copenhagen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Flemming Hjørne, MD
Organizational Affiliation
Dept. of Surgery, Køge Hospital, University of Copenhagen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thue Bisgaard, MD, DrMSc
Organizational Affiliation
Dept. of Surgery, Køge Hospital, University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Surgery K, Bispebjerg Hospital
City
Copenhagen NV
ZIP/Postal Code
DK-2400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lars N Jorgensen, MD, DrMSc
Phone
+45 35316441
Email
larsnjorgensen@hotmail.com
First Name & Middle Initial & Last Name & Degree
Lars N Jorgensen, MD, DrMSc
First Name & Middle Initial & Last Name & Degree
Haytham Al-Tayar, MD
Facility Name
Gentofte Hospital, University of Copenhagen
City
Gentofte
ZIP/Postal Code
DK-2920
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacob Rosenberg, MD, DrMSc
Phone
+45 44883433
Email
jaro@heh.regionh.dk
First Name & Middle Initial & Last Name & Degree
Jacob Rosenberg, MD, DrMSc
First Name & Middle Initial & Last Name & Degree
Sami Assaadzadeh, MD
Facility Name
Dept. of Surgery, Koege Hospital, University of Copenhagen
City
Koege
ZIP/Postal Code
DK-4600
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thue Bisgaard, MD, DrMSc
Phone
+45 47323224
Email
thuebisgaard@tdcadsl.dk
First Name & Middle Initial & Last Name & Degree
Thue Bisgaard, MD, DrMSc
First Name & Middle Initial & Last Name & Degree
Flemming Hjørne, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
24536008
Citation
Jorgensen LN, Rosenberg J, Al-Tayar H, Assaadzadeh S, Helgstrand F, Bisgaard T. Randomized clinical trial of single- versus multi-incision laparoscopic cholecystectomy. Br J Surg. 2014 Mar;101(4):347-55. doi: 10.1002/bjs.9393.
Results Reference
derived

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Single Port Versus Four Ports Laparoscopic Cholecystectomy and Early Postoperative Pain

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