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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:
Information provided by:
G. Hatzikosta General Hospital
ClinicalTrials.gov Identifier:
NCT01116492
First received: May 4, 2010
Last updated: May 20, 2010
Last verified: May 2010
History of Changes
  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 Blind (Subject, 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:

MedlinePlus related topics: Gallstones
U.S. FDA Resources

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01116492

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

No publications provided

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
Study First Received: May 4, 2010
Last Updated: May 20, 2010
Health Authority: Greece: Ethics Committee

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

ClinicalTrials.gov processed this record on June 17, 2013