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

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

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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