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NCT01211743 Clinical Trial

Oxidative Stress in Standard Laparoscopic vs Single Port Cholecystectomy

Laparoscopy Clinical Trial

Official title:
Study of Oxidative Stress in Standard Laparoscopic vs Single Port Cholecystectomy for Uncomplicated Cholelithiasis (Lap vs SILS)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01211743
Other study ID # GH-1948-06
Secondary ID
Status Completed
Phase Phase 4
First received September 28, 2010
Last updated September 28, 2010
Start date June 2010
Est. completion date September 2010

Study information
Verified date September 2010
Source G. Hatzikosta General Hospital
Contact n/a
Is FDA regulated No
Health authority Greece: Ethics Committee
Study type Interventional

Clinical Trial Summary

Study of Oxidative Stress Markers in order to assess whether there are differences between standard laparoscopic cholecystectomy vs single port cholecystectomy for uncomplicated cholelithiasis

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date September 2010
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 65 Years
Eligibility Inclusion Criteria:Uncomplicated cholelithiasis American Society of Anesthesiologists (ASA) I or II No previous operations in upper abdomen Body mass index (BMI) -

Exclusion Criteria:Cholecystitis ASA > II BMI>30 Previous operations in upper abdomen Previous operations in intestine Smokers Alcohol Drugs

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Other:
• Laparoscopic cholecystectomy
Standard 4 port laparoscopic cholecystectomy
• Single incision laparoscopic cholecystectomy
One port placed through the umbilicus

Locations
Country Name City State
Greece G Hatzikosta General Hospital of Ioannina Ioannina Epirus

Sponsors (3)
Lead Sponsor Collaborator
G. Hatzikosta General Hospital Demokrition University of Thrace, University of Ioannina

Country where clinical trial is conducted

Greece, 

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