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

L

Lausanne University Hospital (CHUV)

Status

Completed

Conditions

Cholecystolithiasis

Treatments

Procedure: Standard CCK
Procedure: Single Trocar CCK

Study type

Interventional

Funder types

Other

Identifiers

NCT00974194
SPoCOT_2009

Details and patient eligibility

About

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.

Full 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

Enrollment

268 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Immunodeficiency
  • Choledocholithiasis
  • Previous upperGI open surgery

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

268 participants in 2 patient groups

SinglePort CCK
Experimental group
Description:
CCK using Triport
Treatment:
Procedure: Single Trocar CCK
LS CCK
Active Comparator group
Description:
CCK using three or four trocars
Treatment:
Procedure: Standard CCK

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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