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What should the optimal intrauterine pressure be during diagnostic hysteroscopy? A randomised comparative study
Last registered on February 04, 2016

Pre-Trial

Trial Information
General Information
Title
What should the optimal intrauterine pressure be during diagnostic hysteroscopy? A randomised comparative study
RCT ID
AEARCTR-0001029
Initial registration date
February 04, 2016
Last updated
February 04, 2016 4:16 PM EST
Location(s)
Region
Primary Investigator
Affiliation
YuzuncuYıl University Faculty of Medicine
Other Primary Investigator(s)
PI Affiliation
Yuzuncu yil university, medical faculty deparment of gynecology and obstetric
PI Affiliation
Yuzuncu yil university, medical faculty deparment of gynecology and obstetric
PI Affiliation
Yuzuncu yil university, medical faculty deparment of gynecology and obstetric
PI Affiliation
Yuzuncu yil university, medical faculty deparment of gynecology and obstetric
Additional Trial Information
Status
In development
Start date
2016-02-29
End date
2016-07-01
Secondary IDs
Abstract
Hysteroscopy is a frequently used diagnostic tool used in the evaluation of infertile couples and intrauterine pathologies. There is no concensus on the optimal intrauterin pressure during hysteroscopy in the literature. The lower pressure leads to inadequate visualization however hihger pressure increase the completeness of procedure but increase the pain perceived by patient. We will conduct a randomised comparative study in which the hysteroscopy prucedure will be performed with three different pressure( 40 mmgh, 60 mmgh and 90 mmhg). The primary outcome measure was the proportion of procedures where adequate visibility was achieved during diagnostic outpatient hysteroscopy. The secondary outcome was the level of pain experienced by the patient as assessed using a visual analogue scale.
External Link(s)
Registration Citation
Citation
alkış, İsmet et al. 2016. "What should the optimal intrauterine pressure be during diagnostic hysteroscopy? A randomised comparative study." AEA RCT Registry. February 04. https://doi.org/10.1257/rct.1029-1.0.
Former Citation
alkış, İsmet et al. 2016. "What should the optimal intrauterine pressure be during diagnostic hysteroscopy? A randomised comparative study." AEA RCT Registry. February 04. https://www.socialscienceregistry.org/trials/1029/history/6742.
Experimental Details
Interventions
Intervention(s)
Hysteroscopy is a frequently used diagnostic tool used in infertile couples and evaluation of intrauterine pathologies. There is no concensus on the optimal intrauterin pressure during hysteroscopy in the literature. The lower pressure leads to inadequate visualization however hihger pressure increase the completeness of procedure but increase the pain perceived by patient. We will conduct a randomised comparative study in which the hysteroscopy prucedure will be performed with three different pressure( 40 mmgh, 60 mmgh and 90 mmhg). The primary outcome measure was the proportion of procedures where adequate visibility was achieved during diagnostic outpatient hysteroscopy. The secondary outcome was the level of pain experienced by the patient as assessed using a visual analogue scale.
Intervention Start Date
2016-02-29
Intervention End Date
2016-06-30
Primary Outcomes
Primary Outcomes (end points)
The primary outcome measure was the proportion of procedures where adequate visibility was achieved during diagnostic outpatient hysteroscopy. The secondary outcome was the level of pain experienced by the patient as assessed using a visual analogue scale.
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
The patients will be divided into three groups randomly. Group 1 will undergone the hysteroscopy pressure with 40 mmgh intrauterine pressure.Group 2 with 60 mmhg and group 3 with 90 mmhg intrauterine pressure.
Experimental Design Details
Randomization Method
Randomisation done in office by a computer generated table.
Randomization Unit
The three groups of patents will be randomized according to the intrauterine pressure during hysteroscopy.
Was the treatment clustered?
Yes
Experiment Characteristics
Sample size: planned number of clusters
Group 1:35, group 2:35 group 3:35 patients will be included.
Sample size: planned number of observations
pain analysis with VAS score and completeness of the procedure with number.
Sample size (or number of clusters) by treatment arms
35 patients in each groups.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Yuzuncu Yil University, medical faculty, research and experimental ethics committee
IRB Approval Date
2016-01-28
IRB Approval Number
0
Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
No
Is data collection complete?
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports and Papers
Preliminary Reports
Relevant Papers