Light Physics Enhanced Camera Navigation in Hysteroscopy

NCT ID: NCT04085198

Last Updated: 2020-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-13
• Study Completion Date: 2019-11-25

Brief Summary

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

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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

No-touch technique with the application of light physics rules

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.

Group Type: ACTIVE_COMPARATOR

Light physics enhanced 'no-touch' hysteroscopy

Intervention Type: PROCEDURE

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.

Control

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.

Group Type: PLACEBO_COMPARATOR

Standard hysteroscopy

Intervention Type: PROCEDURE

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

Interventions

Light physics enhanced 'no-touch' hysteroscopy

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.

Intervention Type: PROCEDURE

Standard hysteroscopy

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Huseyin Kiyak

Principal Investigator, M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Huseyin Kiyak, MD

Role: PRINCIPAL_INVESTIGATOR

University of Health Sciences, Faculty of Medicine

Locations

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Please Enter the State Or Province, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Huseyin5

Identifier Type: -

Identifier Source: org_study_id