Light Physics Enhanced Camera Navigation in Hysteroscopy

Study Overview
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Brief Summary
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Office hysteroscopy is the gold standard technique in the diagnosis of the intrauterine pathologies. Some interventions may also be carried out through the hysteroscopy. No-touch hysteroscopy technique confers several advantages in terms of patient discomfort over the traditional technique. Clinicians performing the hysteroscopy find their way from the vaginal introitus to the uterine cavity through direct visualization of the anatomic structures on their route. The investigators hypothesize that the utilization of the information derived from the 'light physics' would facilitate camera navigation during no-touch hysteroscopy and consequently ease reaching the uterus. This study aimed to compare the standard no-touch technique with the 'light physics' enhanced camera navigation in terms of patient comfort and procedural pain.

Detailed Description
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Office hysteroscopy is basically used in the diagnosis of the intrauterine pathologies. 'No touch' vaginal hysteroscopy does not require a speculum or tenaculum; thus, confers advantages in terms of patient discomfort over the traditional technique. The source of the pain in traditional hysteroscopy is the distention of the uterine cavity with the saline and the contact of the hysteroscopy equipment with the vagina and the cervical canal. The benefit in the pain obtained with the 'no-touch' technique is derived from the limitation of the contact of the hysteroscopy equipment with the vagina and the cervical canal. Clinicians performing the hysteroscopy find their way from the vaginal introitus to the uterine cavity through direct visualization of the anatomic structures on their route. Physics has been critical in the development of endoscopic techniques such as laparoscopy, cystoscopy, and hysteroscopy. The light source provides an illumined environment during the imagination with these techniques. During hysteroscopy, the light reflecting from the adjacent tissue appears bright, however, this reflection is weaker in farther tissue and these structures appear dark. With this in mind, the investigators hypothesize that the utilization of the information derived from the 'light physics' would facilitate camera navigation during no-touch hysteroscopy and consequently ease reaching the uterus. This study aimed to compare the standard no-touch technique with the 'light physics' enhanced camera navigation in terms of patient comfort and procedural pain.

Official Title
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Light Physics Enhanced Camera Navigation in No-touch Hysteroscopy: Randomized Controlled Trial

Conditions
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Infertility

Intervention / Treatment
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* Procedure: Light physics enhanced 'no-touch' hysteroscopy
* Procedure: Standard hysteroscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be scheduled for No-touch Office hysteroscopy procedure with a diagnostic purpose Must be nulliparous Exclusion Criteria: Multiparous women Previous cesarean section Cervical stenosis

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: No-touch technique with the application of light physics rules<br>This procedure will be performed by the gynecologists who are familiar to the rules of the 'lights physics' and are currently 'lights physics' rules in their clinical practice. The brightness or darkness of the tissue which reflects the distance between the light source and the surrounding tissue will be used to find the correct route from the vagina introitus to the uterine cavity. | Procedure: Light physics enhanced 'no-touch' hysteroscopy<br>* The light source used in hysteroscopy provides an illumined environment during the imagination with these techniques. During hysteroscopy, the light reflecting from the adjacent tissue appears bright, however, this reflection is weaker in farther tissue and these structures appear dark. This information will be used in determining the route from the vaginal introitus to the uterine cavity during the hysteroscopy.<br>|
| Placebo Comparator: Control<br>Patients in this arm of the study protocol will receive standard hysteroscopy with 'no-touch' technique without the utilization of the 'lights physics' rules. The gynecologist performing this procedure will find their route from the vagina introitus to the uterine cavity by the identification of the anatomical structures on their way. | Procedure: Standard hysteroscopy<br>* Anatomical structures as illumined by the light source of the camera will be used to find the route from the vaginal introitus to the uterine cavity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Pain | The visual analogue scale score for procedural pain (0 to 10, 10 as the most painful) | immediately after the procedure | 
| Procedure time | The time required to perform the hysteroscopy | procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | Patients' self-reported satisfaction (satisfied or not satisfied with the procedure) | immediately after the procedure |