Cholecystolithiasis Clinical Trial
— SPoCOTOfficial title:
Single Port vs Tree Trocars Laparoscopic Cholecystectomy: a Randomized Controlled Trial
Verified date | October 2018 |
Source | University of Lausanne Hospitals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital of Lausanne | Lausanne |
Lead Sponsor | Collaborator |
---|---|
University of Lausanne Hospitals |
Switzerland,
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 |
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