- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01116492
Study of the Inflammatory Reaction in Standard vs Single Port Cholecystectomy for Uncomplicated Cholelithiasis (Lap vs SILS)
May 20, 2010 updated by: G. Hatzikosta General Hospital
This is a study of the inflammatory reaction in standard 4 port laparoscopic cholecystectomy vs Single Port Laparoscopic (SIL) cholecystectomy.
It is assumed that the reduced trauma in SIL Cholecystectomy causes reduced inflammatory reaction compared to the 4 port laparoscopic cholecystectomy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Two groups of 20 patients each are included in this study.
Pre operatively, 6 and 24 hours postoperatively, blood is taken from these patients, it is centrifuged and the plasma is taken.
IL-6, a-defensins and CRP are measured for each sample.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ioannina, Greece, 45001
- "G. Hatzikosta" General Hospital of Ioannina
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Uncomplicated cholelithiasis
- American Society of Anesthesiologists (ASA) I or II
- No previous operations in upper abdomen
- Body mass index (BMI) <30
Exclusion Criteria:
- Cholecystitis
- ASA > II
- BMI>30
- Previous operations in upper abdomen
- Previous operations in intestine
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Lap Group
Patients in this group are operated for uncomplicated cholelithiasis with standard 4 port laparoscopic cholecystectomy
|
Standard 4 port laparoscopic cholecystectomy
|
Active Comparator: SILS group
Patients in this group are operated for uncomplicated cholelithiasis with Single Incision Laparoscopic Cholecystectomy
|
One port placed through the umbilicus
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
May 4, 2010
First Submitted That Met QC Criteria
May 4, 2010
First Posted (Estimate)
May 5, 2010
Study Record Updates
Last Update Posted (Estimate)
May 21, 2010
Last Update Submitted That Met QC Criteria
May 20, 2010
Last Verified
May 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GH-1948-05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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