Oxidative Stress in Standard Laparoscopic vs Single Port Cholecystectomy
This study has been completed.
Sponsor:
G. Hatzikosta General Hospital
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
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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 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:
|
Cholelithiasis Cholecystolithiasis Gallstones Biliary Tract Diseases |
Digestive System Diseases Gallbladder Diseases Calculi Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 19, 2013