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Safety and Cost-effectiveness Study of Single Port Laparoscopic Cholecystectomies (SPoCOT)

Primary Purpose

Cholecystolithiasis

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Single Trocar CCK
Standard CCK
Sponsored by
University of Lausanne Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholecystolithiasis focused on measuring Cholecystolithiasis, Cholecystectomy, Laparoscopic surgery, Single port

Eligibility Criteria

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

Inclusion Criteria:

  • Cholecystolithiasis
  • Age 18 to 75 y.o.
  • BMI < 35

Exclusion Criteria:

  • Immunodeficiency
  • Choledocholithiasis
  • Previous upperGI open surgery

Sites / Locations

  • University Hospital of Lausanne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SinglePort CCK

LS CCK

Arm Description

CCK using Triport

CCK using three or four trocars

Outcomes

Primary Outcome Measures

Pain (value on a Visual Analog Scale)
VAS
Pain (value on a Visual Analog Scale)
VAS
Pain (value on a Visual Analog Scale)
VAS
Pain (value on a Visual Analog Scale)
VAS
Pain (value on a Visual Analog Scale)
VAS

Secondary Outcome Measures

Complications
In euro
Operative time
In euro
Cost analysis
In euro
Cosmetic results
According to POSAS score
Cosmetic results
According to POSAS score
Cosmetic results
According to POSAS score
Complications
According to Clavien classification and CCI
Complications
According to Clavien classification and CCI

Full Information

First Posted
September 8, 2009
Last Updated
October 12, 2018
Sponsor
University of Lausanne Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT00974194
Brief Title
Safety and Cost-effectiveness Study of Single Port Laparoscopic Cholecystectomies
Acronym
SPoCOT
Official Title
Single Port vs Tree Trocars Laparoscopic Cholecystectomy: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2009 (Actual)
Primary Completion Date
September 1, 2017 (Actual)
Study Completion Date
September 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lausanne Hospitals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Many feasibility studies have been published on Single Port surgery, but no comparative studies have shown any advantages compared to standard laparoscopy. The purpose of this study is to compare the clinical outcomes and economical issues of laparoscopic cholecystectomies using single port transumbilical approach and three trocars.
Detailed Description
Design: Prospective Randomized Controlled trial Population analysis based on Intention To Treat Patient and data analyzer blinded (double-blind trial) Outcomes observed: Primary: pain Secondaries: overall operative time, complication rate, cost-effectiveness analysis, cosmetic evaluation, quality of life, CO2 consumption Nbr of patients included: 260 Port used: Triport, Olympus

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystolithiasis
Keywords
Cholecystolithiasis, Cholecystectomy, Laparoscopic surgery, Single port

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
268 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SinglePort CCK
Arm Type
Experimental
Arm Description
CCK using Triport
Arm Title
LS CCK
Arm Type
Active Comparator
Arm Description
CCK using three or four trocars
Intervention Type
Procedure
Intervention Name(s)
Single Trocar CCK
Intervention Description
CCK using Triport
Intervention Type
Procedure
Intervention Name(s)
Standard CCK
Intervention Description
CCK using three or four ports
Primary Outcome Measure Information:
Title
Pain (value on a Visual Analog Scale)
Description
VAS
Time Frame
1 day
Title
Pain (value on a Visual Analog Scale)
Description
VAS
Time Frame
2 days
Title
Pain (value on a Visual Analog Scale)
Description
VAS
Time Frame
1 month
Title
Pain (value on a Visual Analog Scale)
Description
VAS
Time Frame
3 month
Title
Pain (value on a Visual Analog Scale)
Description
VAS
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Complications
Description
In euro
Time Frame
1 month
Title
Operative time
Description
In euro
Time Frame
Operative day
Title
Cost analysis
Description
In euro
Time Frame
1 year
Title
Cosmetic results
Description
According to POSAS score
Time Frame
1 month
Title
Cosmetic results
Description
According to POSAS score
Time Frame
3 month
Title
Cosmetic results
Description
According to POSAS score
Time Frame
1 year
Title
Complications
Description
According to Clavien classification and CCI
Time Frame
3 month
Title
Complications
Description
According to Clavien classification and CCI
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cholecystolithiasis Age 18 to 75 y.o. BMI < 35 Exclusion Criteria: Immunodeficiency Choledocholithiasis Previous upperGI open surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Allemann, MD
Organizational Affiliation
CHV/CHUV
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Lausanne
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

Links:
URL
http://www.chirurgieviscerale.ch
Description
Internet page of our departement

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Safety and Cost-effectiveness Study of Single Port Laparoscopic Cholecystectomies

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