Oxidative Stress in Standard Laparoscopic vs Single Port Cholecystectomy

Sponsor

G. Hatzikosta General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01211743

Collaborator

Demokrition University of Thrace (Other), University of Ioannina (Other)

Enrollment

Location

Arms

Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Uncomplicated Cholelithiasis Cholecystectomy Laparoscopy Standard Technique Single Port Laparoscopy	Other: Laparoscopic cholecystectomy Other: Single incision laparoscopic cholecystectomy	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

Jun 1, 2010

Actual Study Completion Date :

Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Lap Group Patients in this group are operated for uncomplicated cholelithiasis with standard 4 port laparoscopic cholecystectomy	Other: Laparoscopic cholecystectomy Standard 4 port laparoscopic cholecystectomy Other: Single incision laparoscopic cholecystectomy One port placed through the umbilicus
Active Comparator: SILS group Patients in this group are operated for uncomplicated cholelithiasis with Single Incision Laparoscopic Cholecystectomy	Other: Single incision laparoscopic cholecystectomy One port placed through the umbilicus

Arm

Intervention/Treatment

Active Comparator: Lap Group

Patients in this group are operated for uncomplicated cholelithiasis with standard 4 port laparoscopic cholecystectomy

Other: Laparoscopic cholecystectomy

Standard 4 port laparoscopic cholecystectomy

Other: Single incision laparoscopic cholecystectomy

One port placed through the umbilicus

Active Comparator: SILS group

Patients in this group are operated for uncomplicated cholelithiasis with Single Incision Laparoscopic Cholecystectomy

Other: Single incision laparoscopic cholecystectomy

One port placed through the umbilicus

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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