Light Physics Enhanced Camera Navigation in Hysteroscopy

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

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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Procedure: Light physics enhanced 'no-touch' hysteroscopy; Procedure: Standard hysteroscopy

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.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Please Enter The State Or Province
    • Istanbul, Please Enter The State Or Province, Turkey, 34005
      • Kanuni Sultan Suleyman Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: 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.
Placebo Comparator: 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.	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital
• Investigators: Principal Investigator: Huseyin Kiyak, MD, University of Health Sciences, Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2019
• Primary Completion (Actual): November 20, 2019
• Study Completion (Actual): November 25, 2019

Study Registration Dates

• First Submitted: September 9, 2019
• First Submitted That Met QC Criteria: September 10, 2019
• First Posted (Actual): September 11, 2019

Study Record Updates

• Last Update Posted (Actual): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 19, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: Huseyin5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No