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Oxidative Stress in Standard Laparoscopic vs Single Port Cholecystectomy

This study has been completed.
Sponsor:
Collaborators:
Demokrition University of Thrace
University of Ioannina
Information provided by:
G. Hatzikosta General Hospital
ClinicalTrials.gov Identifier:
NCT01211743
First received: September 28, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  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: Double Blind (Subject, Caregiver, 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

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 28, 2010
Last Updated: September 28, 2010
Health Authority: Greece: Ethics Committee

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

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

ClinicalTrials.gov processed this record on November 24, 2014