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

This study is currently recruiting participants.
Verified April 2012 by University of Lausanne Hospitals
Sponsor:
Information provided by (Responsible Party):
Nicolas DEMARTINES, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT00974194
First received: September 8, 2009
Last updated: April 21, 2012
Last verified: April 2012
History of Changes
  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 Phase
Cholecystolithiasis
 Procedure: Single Trocar CCK
Procedure: Standard CCK
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Single Port vs Tree Trocars Laparoscopic Cholecystectomy: a Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Gallstones
U.S. FDA Resources

Further study details as provided by University of Lausanne Hospitals:

Primary Outcome Measures:
  • Pain [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complications [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Operative time [ Time Frame: Operative day ] [ Designated as safety issue: No ]
  • Cost analysis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Cosmetic results [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Cosmetic results [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • Cosmetic results [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Complications [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]
  • Complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 260
Study Start Date: September 2009
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: December 2012 (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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00974194

Contacts
Contact: Pierre Allemann, MD +41213147526 pierre.allemann@chuv.ch

Locations
Switzerland
University Hospital of Lausanne Recruiting
Lausanne, Switzerland, 1011
Contact: Pierre Allemann, MD     +41213147526     pierre.allemann@chuv.ch    
Principal Investigator: Pierre Allemann, MD            
Sub-Investigator: Adrien Tempia, MD            
Sub-Investigator: Nermin Halkic, MD, MER            
Sub-Investigator: Nicolas Demartines, MD, FACS            
Sponsors and Collaborators
University of Lausanne Hospitals
Investigators
Principal Investigator: Pierre Allemann, MD CHV/CHUV
  More Information

Additional Information:
Internet page of our departement  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Nicolas DEMARTINES, professor of surgery, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT00974194     History of Changes
Other Study ID Numbers: SPoCOT_2009
Study First Received: September 8, 2009
Last Updated: April 21, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by 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

ClinicalTrials.gov processed this record on May 23, 2013