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Study of the Inflammatory Reaction in Standard vs Single Port Cholecystectomy for Uncomplicated Cholelithiasis (Lap vs SILS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01116492
First Posted: May 5, 2010
Last Update Posted: May 21, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
G. Hatzikosta General Hospital
  Purpose
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.

Condition Intervention
Cholelithiasis Inflammatory Response Other: Single incision laparoscopic cholecystectomy Other: Laparoscopic cholecystectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Study of the Inflammatory Reaction in Standard vs Single Port Cholecystectomy for Uncomplicated Cholelithiasis

Resource links provided by NLM:


Further study details as provided by G. Hatzikosta General Hospital:

Enrollment: 40
Study Start Date: January 2010
Study Completion Date: May 2010
Primary Completion Date: May 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
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01116492


Locations
Greece
"G. Hatzikosta" General Hospital of Ioannina
Ioannina, Greece, 45001
Sponsors and Collaborators
G. Hatzikosta General Hospital
  More Information

Responsible Party: Konstantinos Tsimogiannis MD, "G. Hatzikosta" General Hospital of Ioannina
ClinicalTrials.gov Identifier: NCT01116492     History of Changes
Other Study ID Numbers: GH-1948-05
First Submitted: May 4, 2010
First Posted: May 5, 2010
Last Update Posted: May 21, 2010
Last Verified: May 2010

Keywords provided by G. Hatzikosta General Hospital:
SILS
Inflammatory reaction
a-defensins
SILS vs standard laparoscopic cholecystectomy

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