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Completed

NCT Number: NCT00974194

Safety and Cost-effectiveness Study of Single Port Laparoscopic Cholecystectomies

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.

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Key information

Conditions

Cholecystolithiasis Biliary Tract Diseases Cholelithiasis Digestive System Diseases Gallbladder Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Lausanne

Lausanne, 1011, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Immunodeficiency
  • Choledocholithiasis
  • Previous upperGI open surgery

Treatment and study plan

Single Trocar CCK

Procedure

CCK using Triport

Standard CCK

Procedure

CCK using three or four ports

Primary outcomes

  1. Pain (value on a Visual Analog Scale)

    Time frame: 1 day

    VAS

  2. Pain (value on a Visual Analog Scale)

    Time frame: 2 days

    VAS

  3. Pain (value on a Visual Analog Scale)

    Time frame: 1 month

    VAS

  4. Pain (value on a Visual Analog Scale)

    Time frame: 3 month

    VAS

  5. Pain (value on a Visual Analog Scale)

    Time frame: 1 year

    VAS

Secondary outcomes

  1. Complications

    Time frame: 1 month

    In euro

  2. Operative time

    Time frame: Operative day

    In euro

  3. Cost analysis

    Time frame: 1 year

    In euro

  4. Cosmetic results

    Time frame: 1 month

    According to POSAS score

  5. Cosmetic results

    Time frame: 3 month

    According to POSAS score

  6. Cosmetic results

    Time frame: 1 year

    According to POSAS score

  7. Complications

    Time frame: 3 month

    According to Clavien classification and CCI

  8. Complications

    Time frame: 1 year

    According to Clavien classification and CCI

Sponsors and collaborators

Lead sponsor

University of Lausanne Hospitals

Other

Registry information

Official study title

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

Acronym: SPoCOT

Important dates

Study start
2009
Primary completion
2017
Study completion
2018
First posted
Sep 10, 2009
Registry last updated
Oct 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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