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Evaluation of Abdominal Wall Lifting During Laparoscopic Direct Trocar Insertion

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Bagcilar Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT01726231
First received: November 9, 2012
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
  Purpose

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
Other Surgical Procedures

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Evaluation of Abdominal Wall Lifting During Laparoscopic Direct Trocar Insertion

Further study details as provided by Bagcilar Training and Research Hospital:

Primary Outcome Measures:
  • 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. [ Time Frame: 2-3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

the patiens undergoing laparoscopic surgery for various indications

Criteria

Inclusion Criteria:

  • the patients who performed laparoscopic surgery

Exclusion Criteria:

  • the patients who suspected pregnancy
  • large scale intrabdominal mass
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726231

Locations
Turkey
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
  More Information

No publications provided

Responsible Party: Bagcilar Training and Research Hospital
ClinicalTrials.gov Identifier: NCT01726231     History of Changes
Other Study ID Numbers: BEH GynObs-2
Study First Received: November 9, 2012
Last Updated: February 12, 2013
Health Authority: Turkey: Ministry of Health

Keywords provided by Bagcilar Training and Research Hospital:
Laparoscopic access
Abdominal wall lifting
Direct trocar insertion
Safety endoscopy

ClinicalTrials.gov processed this record on May 19, 2013