Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-26 @ 4:46 AM
Study NCT ID:
NCT00974194
Status:
COMPLETED
Last Update Posted:
2018-10-17
First Post:
2009-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Cost-effectiveness Study of Single Port Laparoscopic Cholecystectomies
Sponsor:
University of Lausanne Hospitals
Organization:
Study Overview
Official Title:
Single Port vs Tree Trocars Laparoscopic Cholecystectomy: a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPoCOT
Brief 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.
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
* 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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: