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Oxidative Stress in Standard Laparoscopic vs Single Port Cholecystectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01211743
First Posted: September 29, 2010
Last Update Posted: September 29, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Demokrition University of Thrace
University of Ioannina
Information provided by:
G. Hatzikosta General Hospital
  Purpose
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 Intervention Phase
Uncomplicated Cholelithiasis Cholecystectomy Laparoscopy Standard Technique Single Port Laparoscopy Other: Laparoscopic cholecystectomy Other: Single incision laparoscopic cholecystectomy Phase 4

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by G. Hatzikosta General Hospital:

Enrollment: 20
Study Start Date: June 2010
Study Completion Date: September 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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

  Contacts and Locations
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
  More Information

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 Submitted: September 28, 2010
First Posted: September 29, 2010
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