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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00974194
First Posted: September 10, 2009
Last Update Posted: November 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nicolas DEMARTINES, University of Lausanne Hospitals
  Purpose
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.

Condition Intervention
Cholecystolithiasis Procedure: Single Trocar CCK Procedure: Standard CCK

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Single Port vs Tree Trocars Laparoscopic Cholecystectomy: a Randomized Controlled Trial

Further study details as provided by Nicolas DEMARTINES, University of Lausanne Hospitals:

Primary Outcome Measures:
  • Pain [ Time Frame: 1 day ]
  • Pain [ Time Frame: 2 days ]
  • Pain [ Time Frame: 1 month ]
  • Pain [ Time Frame: 3 month ]
  • Pain [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Complications [ Time Frame: 1 month ]
  • Operative time [ Time Frame: Operative day ]
  • Cost analysis [ Time Frame: 1 year ]
  • Cosmetic results [ Time Frame: 1 month ]
  • Cosmetic results [ Time Frame: 3 month ]
  • Cosmetic results [ Time Frame: 1 year ]
  • Complications [ Time Frame: 3 month ]
  • Complications [ Time Frame: 1 year ]

Enrollment: 268
Actual Study Start Date: September 2009
Estimated Study Completion Date: September 1, 2018
Primary Completion Date: September 1, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Immunodeficiency
  • Choledocholithiasis
  • Previous upperGI open surgery
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00974194


Locations
Switzerland
University Hospital of Lausanne
Lausanne, Switzerland, 1011
Sponsors and Collaborators
University of Lausanne Hospitals
Investigators
Principal Investigator: Pierre Allemann, MD CHV/CHUV
  More Information

Additional Information:
Responsible Party: Nicolas DEMARTINES, professor of surgery, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT00974194     History of Changes
Other Study ID Numbers: SPoCOT_2009
First Submitted: September 8, 2009
First Posted: September 10, 2009
Last Update Posted: November 15, 2017
Last Verified: November 2017

Keywords provided by Nicolas DEMARTINES, University of Lausanne Hospitals:
Cholecystolithiasis
Cholecystectomy
Laparoscopic surgery
Single port

Additional relevant MeSH terms:
Cholecystolithiasis
Cholelithiasis
Gallstones
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical