search
Back to results

Comparison of Single İncision Laparoscopic Cholecystectomy Versus Laparoscopic Cholecystectomy

Primary Purpose

Laparoscopic Surgical Procedures

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laparoscopic Cholecystectomy (Single Incision)
Laparoscopic Cholecystectomy (Conventional)
Sponsored by
Ankara Mevki Military Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laparoscopic Surgical Procedures focused on measuring Single İncision Laparoscopic Surgery, Conventional Laparoscopic Surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • The patients who were scheduled for elective cholecystectomy were included in the study

Exclusion Criteria:

  • pregnancy
  • acute cholecystitis
  • ASA 3-4 (American Society of Anesthesiologists)
  • history of bile duct stone migration
  • biller pancreatitis
  • upper laparatomy
  • any ventral hernia repair
  • chronic systemic disease or
  • with allergic attitude to any agent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Laparoscopic Cholecystectomy (SILC)

    Laparoscopic Cholecystectomy (CLC)

    Arm Description

    Group 1: Single Incision Laparoscopic Cholecystectomy (Intervention)

    Group 2: Conventional Laparoscopic Cholecystectomy (Intervention)

    Outcomes

    Primary Outcome Measures

    Quality of life measure

    Secondary Outcome Measures

    Body Image Questionnaire measure

    Full Information

    First Posted
    April 8, 2015
    Last Updated
    April 15, 2015
    Sponsor
    Ankara Mevki Military Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02417857
    Brief Title
    Comparison of Single İncision Laparoscopic Cholecystectomy Versus Laparoscopic Cholecystectomy
    Official Title
    Quality-of-life, Body Image and Cosmesis After Single Incision Laparoscopic Cholecystectomy (SILC) Versus Conventional Laparoscopic Cholecystectomy (CLC)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2011 (undefined)
    Primary Completion Date
    March 2013 (Actual)
    Study Completion Date
    March 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ankara Mevki Military Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The aim of this study is to compare outcomes of quality-of-life measures and evaluate the body image and cosmesis between Single Incision Laparoscopic Cholecystectomy (SILC) and Conventional Laparoscopic Cholecystectomy (CLC).Twenty eight patients underwent SILC and 30 underwent LC.Fifty-eight patients were included the study and divided into two groups. The results of the questionnaires were statistically compared.
    Detailed Description
    Recently, single incision laparoscopic cholecystectomy (SILC) is one of the minimally invasive technique, developed to reduce the need of multiple ports and has become popular among the surgeons. This study was conducted with fifty eight patients between January 2011 and March 2013 in Turkey. Fifty-eight patients were included the study and divided into two groups. Quality-of-life measures was evaluated by the EuroQol EQ-5D questionnaire.Cosmesis and body image were evaluated with the Body Image Questionnaire. All statistical analyses were performed by IBM Statistics 21.0 and MS-Excel 2007. A value of p<0.05 was accepted as statistically significant.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Laparoscopic Surgical Procedures
    Keywords
    Single İncision Laparoscopic Surgery, Conventional Laparoscopic Surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    58 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Laparoscopic Cholecystectomy (SILC)
    Arm Type
    Experimental
    Arm Description
    Group 1: Single Incision Laparoscopic Cholecystectomy (Intervention)
    Arm Title
    Laparoscopic Cholecystectomy (CLC)
    Arm Type
    Experimental
    Arm Description
    Group 2: Conventional Laparoscopic Cholecystectomy (Intervention)
    Intervention Type
    Procedure
    Intervention Name(s)
    Laparoscopic Cholecystectomy (Single Incision)
    Intervention Description
    We performed Single Incision Laparoscopic Cholecystectomy (SILC) operation to the group-1
    Intervention Type
    Procedure
    Intervention Name(s)
    Laparoscopic Cholecystectomy (Conventional)
    Intervention Description
    We performed Conventional Laparoscopic Cholecystectomy (CLC) to group-2
    Primary Outcome Measure Information:
    Title
    Quality of life measure
    Time Frame
    We had performed the questionnaire at postoperative 6 th month
    Secondary Outcome Measure Information:
    Title
    Body Image Questionnaire measure
    Time Frame
    We had performed the questionnaire at postoperative 6 th month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: The patients who were scheduled for elective cholecystectomy were included in the study Exclusion Criteria: pregnancy acute cholecystitis ASA 3-4 (American Society of Anesthesiologists) history of bile duct stone migration biller pancreatitis upper laparatomy any ventral hernia repair chronic systemic disease or with allergic attitude to any agent
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Huseyin SINAN, Prof. M.D.
    Organizational Affiliation
    VAN MILITARY HOSPITAL, GENERAL SURGERY DEPARTMENT, VAN, TURKEY
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23269370
    Citation
    Abd Ellatif ME, Askar WA, Abbas AE, Noaman N, Negm A, El-Morsy G, El Nakeeb A, Magdy A, Amin M. Quality-of-life measures after single-access versus conventional laparoscopic cholecystectomy: a prospective randomized study. Surg Endosc. 2013 Jun;27(6):1896-906. doi: 10.1007/s00464-012-2625-5. Epub 2012 Dec 27.
    Results Reference
    result

    Learn more about this trial

    Comparison of Single İncision Laparoscopic Cholecystectomy Versus Laparoscopic Cholecystectomy

    We'll reach out to this number within 24 hrs