- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01726231
Evaluation of Abdominal Wall Lifting During Laparoscopic Direct Trocar Insertion
December 24, 2013 updated by: Bagcilar Training and Research Hospital
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Istanbul, Turkey
- Bagcilar Training and Research Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
the patiens undergoing laparoscopic surgery for various indications
Description
Inclusion Criteria:
- the patients who performed laparoscopic surgery
Exclusion Criteria:
- the patients who suspected pregnancy
- large scale intrabdominal mass
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
2-3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: TANER A USTA, M.D., Bagcilar Training and Research Hospital, Istanbul, Turkey
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
November 9, 2012
First Submitted That Met QC Criteria
November 9, 2012
First Posted (Estimate)
November 14, 2012
Study Record Updates
Last Update Posted (Estimate)
December 25, 2013
Last Update Submitted That Met QC Criteria
December 24, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- BEH GynObs-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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