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

Sponsor
G. Hatzikosta General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01116492
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
3.9
Duration (Months)
10.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Single incision laparoscopic cholecystectomy
  • Other: Laparoscopic cholecystectomy
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
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
Study Start Date :
Jan 1, 2010
Actual Primary Completion Date :
May 1, 2010
Actual Study Completion Date :
May 1, 2010

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    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

    Locations

    Site City State Country Postal Code
    1 "G. Hatzikosta" General Hospital of Ioannina Ioannina Greece 45001

    Sponsors and Collaborators

    • G. Hatzikosta General Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01116492
    Other Study ID Numbers:
    • GH-1948-05
    First Posted:
    May 5, 2010
    Last Update Posted:
    May 21, 2010
    Last Verified:
    May 1, 2010
    Keywords provided by , ,
    SILS
    Inflammatory reaction
    a-defensins
    SILS vs standard laparoscopic cholecystectomy
    Additional relevant MeSH terms:
    Cholelithiasis
    Cholecystolithiasis
    Gallstones
    Inflammation

    Study Results

    No Results Posted as of May 21, 2010