This Study Performed to Develop a New Technique for Measuring the Intra Abdominal Pressure
The Increase of Intra-abdominal Pressure Can Affect Intra-ocular Pressure.
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of this study is to evaluate the changes of intraocular pressure due to the increase of intra abdominal pressure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 7, 2014
CompletedFirst Posted
Study publicly available on registry
December 18, 2014
CompletedDecember 18, 2014
December 1, 2014
10 months
December 7, 2014
December 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
intra-abdominal pressure
Changes in intraabdominal pressure
1 day after the surgery.
Study Arms (4)
Group C
NO INTERVENTIONThe control group (Group C) was not subjected to laparoscopic intervention
Group L
EXPERIMENTALIntraocular pressure measurement with 9 mmHg insufflation
Group M
EXPERIMENTALIntraocular pressure measurement with 12 mmHg insufflation
Group H
EXPERIMENTALIntraocular pressure measurement with 15 mmHg insufflation
Interventions
Comparison of intraocular pressure levels at different abdominal pressure
Comparison of intraocular pressure levels at different abdominal pressure
Comparison of intraocular pressure levels at different abdominal pressure
Eligibility Criteria
You may qualify if:
- Body mass index (BMI) of 30 kg/m2 or less
- American Society of Anesthesiologists (ASA) status I-II
You may not qualify if:
- Pre-existing eye disease,
- Cardiovascular or neuromuscular disease,
- Difficult intubation,
- The use of any antihypertensive agents.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Selcuk University
Konya, Konya, 42075, Turkey (Türkiye)
Related Publications (1)
Ece I, Vatansev C, Kucukkartallar T, Tekin A, Kartal A, Okka M. The increase of intra-abdominal pressure can affect intraocular pressure. Biomed Res Int. 2015;2015:986895. doi: 10.1155/2015/986895. Epub 2015 Jan 14.
PMID: 25648230DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
İlhan Ece
Selcuk Universitesi Tip Fakultesi Genel Cerrahi poliklinigi
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Surgery.
Study Record Dates
First Submitted
December 7, 2014
First Posted
December 18, 2014
Study Start
March 1, 2008
Primary Completion
January 1, 2009
Study Completion
November 1, 2009
Last Updated
December 18, 2014
Record last verified: 2014-12