Safety and Cost-effectiveness Study of Single Port Laparoscopic Cholecystectomies

Cholecystolithiasis Clinical Trial

— SPoCOT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00974194
• Other study ID #: SPoCOT_2009
• Status: Completed
• Phase: N/A
• Start date: September 2009
• Est. completion date: September 1, 2018

Study information

• Verified date: October 2018
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: September 1, 2018
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Cholecystolithiasis

• Age 18 to 75 y.o.

• BMI < 35

Exclusion Criteria:

• Immunodeficiency

• Choledocholithiasis

• Previous upperGI open surgery

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

Procedure:
• Single Trocar CCK
CCK using Triport
• Standard CCK
CCK using three or four ports

Locations

Country	Name	City	State
Switzerland	University Hospital of Lausanne	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain (value on a Visual Analog Scale)	VAS	1 day
Primary	Pain (value on a Visual Analog Scale)	VAS	2 days
Primary	Pain (value on a Visual Analog Scale)	VAS	1 month
Primary	Pain (value on a Visual Analog Scale)	VAS	3 month
Primary	Pain (value on a Visual Analog Scale)	VAS	1 year
Secondary	Complications	In euro	1 month
Secondary	Operative time	In euro	Operative day
Secondary	Cost analysis	In euro	1 year
Secondary	Cosmetic results	According to POSAS score	1 month
Secondary	Cosmetic results	According to POSAS score	3 month
Secondary	Cosmetic results	According to POSAS score	1 year
Secondary	Complications	According to Clavien classification and CCI	3 month
Secondary	Complications	According to Clavien classification and CCI	1 year

External Links

•   Internet page of our departement