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Evaluation of Abdominal Wall Lifting During Laparoscopic Direct Trocar Insertion

Sponsor
Bagcilar Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01726231
Collaborator
(none)
40
Enrollment
1
Location
13
Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In laparoscopy, over %50 of the all complications occur during establishment of the pneumoperitoneum. Lifting of the anterior abdominal wall is aimed to increase the distance between the abdominal wall and the intrabdominal structures. Elevation of the anterior abdominal wall is recommended for the access to peritoneal cavity in literatures however the benefit exactly has not proved. This study aimed to determine the distance from anterior abdominal wall to intraperitoneal structures during lifting of the abdominal wall, to represent this distance -on the average- generate the safe range whether or not and compare with this distance and patient's age, BMI and parity.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    40 patients who undergoing laparoscopic surgery for various indications are enrolled in the study. The telescope is inserted at second trocar place and the distances between anterior abdominal wall and visceral organs are measured with plastic hysterometry during maximal elevation of the abdominal wall.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    40 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Evaluation of Abdominal Wall Lifting During Laparoscopic Direct Trocar Insertion
    Study Start Date :
    Nov 1, 2012
    Actual Primary Completion Date :
    Dec 1, 2013
    Actual Study Completion Date :
    Dec 1, 2013

    Outcome Measures

    Primary Outcome Measures

    1. The primary outcome measure of this study is to determine the distance in centimeters from anterior abdominal wall to intraperitoneal visceral structures during lifting of the abdominal wall with plastic hysterometry. [2-3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • the patients who performed laparoscopic surgery
    Exclusion Criteria:

    • the patients who suspected pregnancy

    • large scale intrabdominal mass

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bagcilar Training and Research Hospital Istanbul Turkey

    Sponsors and Collaborators

    • Bagcilar Training and Research Hospital

    Investigators

    • Principal Investigator: TANER A USTA, M.D., Bagcilar Training and Research Hospital, Istanbul, Turkey

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bagcilar Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT01726231
    Other Study ID Numbers:
    • BEH GynObs-2
    First Posted:
    Nov 14, 2012
    Last Update Posted:
    Dec 25, 2013
    Last Verified:
    Dec 1, 2013
    Keywords provided by Bagcilar Training and Research Hospital
    Laparoscopic access
    Abdominal wall lifting
    Direct trocar insertion
    Safety endoscopy

    Study Results

    No Results Posted as of Dec 25, 2013