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

October 12, 2018 updated by: Nicolas DEMARTINES, University of Lausanne Hospitals

Single Port vs Tree Trocars Laparoscopic Cholecystectomy: a Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

268

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Lausanne, Switzerland, 1011
        • University Hospital of Lausanne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Immunodeficiency
  • Choledocholithiasis
  • Previous upperGI open surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SinglePort CCK
CCK using Triport
Procedure: Single Trocar CCK
CCK using Triport
Active Comparator: LS CCK
CCK using three or four trocars
Procedure: Standard CCK
CCK using three or four ports

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain (value on a Visual Analog Scale)
Time Frame: 1 day
VAS
1 day
Pain (value on a Visual Analog Scale)
Time Frame: 2 days
VAS
2 days
Pain (value on a Visual Analog Scale)
Time Frame: 1 month
VAS
1 month
Pain (value on a Visual Analog Scale)
Time Frame: 3 month
VAS
3 month
Pain (value on a Visual Analog Scale)
Time Frame: 1 year
VAS
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 1 month
In euro
1 month
Operative time
Time Frame: Operative day
In euro
Operative day
Cost analysis
Time Frame: 1 year
In euro
1 year
Cosmetic results
Time Frame: 1 month
According to POSAS score
1 month
Cosmetic results
Time Frame: 3 month
According to POSAS score
3 month
Cosmetic results
Time Frame: 1 year
According to POSAS score
1 year
Complications
Time Frame: 3 month
According to Clavien classification and CCI
3 month
Complications
Time Frame: 1 year
According to Clavien classification and CCI
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lausanne Hospitals

Investigators

  • Principal Investigator: Pierre Allemann, MD, CHV/CHUV

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2009

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

September 8, 2009

First Submitted That Met QC Criteria

September 9, 2009

First Posted (Estimate)

September 10, 2009

Study Record Updates

Last Update Posted (Actual)

October 17, 2018

Last Update Submitted That Met QC Criteria

October 12, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPoCOT_2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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