Back to resultsStudy of the Inflammatory Reaction in Standard vs Single Port Cholecystectomy for Uncomplicated Cholelithiasis (Lap vs SILS)
Primary Purpose
Cholelithiasis, Inflammatory Response
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Single incision laparoscopic cholecystectomy
Laparoscopic cholecystectomy
Sponsored by
About this trial
This is an interventional basic science trial for Cholelithiasis focused on measuring SILS, Inflammatory reaction, a-defensins, SILS vs standard laparoscopic cholecystectomy
Eligibility Criteria
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
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
NCT ID
NCT01116492
First Posted
May 4, 2010
Last Updated
May 20, 2010
Sponsor
G. Hatzikosta General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01116492
Brief Title
Study of the Inflammatory Reaction in Standard vs Single Port Cholecystectomy for Uncomplicated Cholelithiasis
Acronym
Lap vs SILS
Official Title
Study of the Inflammatory Reaction in Standard vs Single Port Cholecystectomy for Uncomplicated Cholelithiasis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
G. Hatzikosta General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholelithiasis, Inflammatory Response
Keywords
SILS, Inflammatory reaction, a-defensins, SILS vs standard laparoscopic cholecystectomy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (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)
Single incision laparoscopic cholecystectomy
Intervention Description
One port placed through the umbilicus
Intervention Type
Other
Intervention Name(s)
Laparoscopic cholecystectomy
Intervention Description
Standard 4 port laparoscopic cholecystectomy
10. Eligibility
Sex
All
Eligibility Criteria
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
Facility Information:
Facility Name
"G. Hatzikosta" General Hospital of Ioannina
City
Ioannina
ZIP/Postal Code
45001
Country
Greece
12. IPD Sharing Statement
Learn more about this trial
Study of the Inflammatory Reaction in Standard vs Single Port Cholecystectomy for Uncomplicated Cholelithiasis
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