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Oxidative Stress in Standard Laparoscopic vs Single Port Cholecystectomy

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ClinicalTrials.gov Identifier: NCT01211743
Recruitment Status : Completed
First Posted : September 29, 2010
Last Update Posted : September 29, 2010
Sponsor:
Collaborators:
Demokrition University of Thrace
University of Ioannina
Information provided by:
G. Hatzikosta General Hospital

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 Type : Interventional  (Clinical Trial)
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 : June 2010
Actual Primary Completion Date : June 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gallstones
U.S. FDA Resources

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




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Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01211743


Locations
Greece
G Hatzikosta General Hospital of Ioannina
Ioannina, Epirus, Greece, 45001
Sponsors and Collaborators
G. Hatzikosta General Hospital
Demokrition University of Thrace
University of Ioannina

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: George Pappas-Gogos MD, G Hatzikosta General Hospital of Ioannina
ClinicalTrials.gov Identifier: NCT01211743     History of Changes
Other Study ID Numbers: GH-1948-06
First Posted: September 29, 2010    Key Record Dates
Last Update Posted: September 29, 2010
Last Verified: September 2010

Keywords provided by G. Hatzikosta General Hospital:
SILS
Oxidative Stress
8-epiPGF2a
SILS vs standard laparoscopic cholecystectomy

Additional relevant MeSH terms:
Cholelithiasis
Cholecystolithiasis
Gallstones
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical