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Oxidative Stress in Standard Laparoscopic vs Single Port Cholecystectomy

Primary Purpose

Uncomplicated Cholelithiasis, Cholecystectomy, Laparoscopy

Status
Completed
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
Laparoscopic cholecystectomy
Single incision laparoscopic cholecystectomy
Sponsored by
G. Hatzikosta General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Uncomplicated Cholelithiasis focused on measuring SILS, Oxidative Stress, 8-epiPGF2a, SILS vs standard laparoscopic cholecystectomy

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

-

Sites / Locations

  • G Hatzikosta General Hospital of Ioannina

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Lap Group

SILS group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 28, 2010
Last Updated
September 28, 2010
Sponsor
G. Hatzikosta General Hospital
Collaborators
Demokrition University of Thrace, University of Ioannina
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1. Study Identification

Unique Protocol Identification Number
NCT01211743
Brief Title
Oxidative Stress in Standard Laparoscopic vs Single Port Cholecystectomy
Official Title
Study of Oxidative Stress in Standard Laparoscopic vs Single Port Cholecystectomy for Uncomplicated Cholelithiasis (Lap vs SILS)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
G. Hatzikosta General Hospital
Collaborators
Demokrition University of Thrace, University of Ioannina

4. Oversight

Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uncomplicated Cholelithiasis, Cholecystectomy, Laparoscopy, Standard Technique, Single Port Laparoscopy
Keywords
SILS, Oxidative Stress, 8-epiPGF2a, SILS vs standard laparoscopic cholecystectomy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lap Group
Arm Type
Active Comparator
Arm Description
Patients in this group are operated for uncomplicated cholelithiasis with standard 4 port laparoscopic cholecystectomy
Arm Title
SILS group
Arm Type
Active Comparator
Arm Description
Patients in this group are operated for uncomplicated cholelithiasis with Single Incision Laparoscopic Cholecystectomy
Intervention Type
Other
Intervention Name(s)
Laparoscopic cholecystectomy
Intervention Description
Standard 4 port laparoscopic cholecystectomy
Intervention Type
Other
Intervention Name(s)
Single incision laparoscopic cholecystectomy
Intervention Description
One port placed through the umbilicus

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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 -
Facility Information:
Facility Name
G Hatzikosta General Hospital of Ioannina
City
Ioannina
State/Province
Epirus
ZIP/Postal Code
45001
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
25438954
Citation
Pappas-Gogos G, Tellis CC, Trypsianis G, Tsimogiannis KE, Tsimoyiannis EC, Simopoulos CE, Pitiakoudis M, Tselepis AD. Oxidative stress in multi-port and single-port cholecystectomy. J Surg Res. 2015 Mar;194(1):101-6. doi: 10.1016/j.jss.2014.09.020. Epub 2014 Sep 28.
Results Reference
derived

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Oxidative Stress in Standard Laparoscopic vs Single Port Cholecystectomy

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