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

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
February 04, 2016, 4:16 PM EST

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

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

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials