Tight Vaginoscopy: a Simplified Novel Technique for a Better Vaginal Surgery

Assiut University

Status and phase: Completed; Phase 2

Conditions: Endosalpingiosis

Treatments: Device: Tight vaginoscope

Study type: Interventional

Funder types: Other

Identifiers

NCT03024242

TVS

Details and patient eligibility

About

Bivalve vaginal speculum insertion is a basic final step of vaginal examination. Unfortunately, it can't be inserted in young girls, virgins, nulliparous women with narrow vagina, women with vaginismus or patients with a history of previous vaginal surgery. In such cases, the value of vaginoscopy (examination of the vagina without speculum) is evident. Indications of vaginoscopy are expanding. In addition to confirmation of suspected vaginal masses or polypi diagnosis, it can be used to diagnose laceration of the vaginal wall in girls due to foreign body , traumatic injuries or sexual abuse. In a systematic review, the effectiveness and feasibility of using hysteroscopy for exploration of the immature genital tract (vaginoscopy) were documented.It may help in the diagnosis and treatment of gynecologic disorders in adolescent patients with an intact hymen, limited vaginal access, or a narrow vagina. Another recent systematic review highlighted the importance of Vagino-hysteroscopy as an easy way to gain access to the cervical canal and an important tool with which to diagnose and treat vaginal lesions.

In practice, we notice leakage of excessive irrigating fluid per vagina with poor visualization during vaginoscopy. To the best of our knowledge, no study addressed a solution to improve visualization and success of vaginoscopic surgery. This study aims to test feasibility and doctor satisfaction of performing conventional diagnostic vaginoscopy if compared to tight diagnostic vaginoscopy and success on performing tight vaginoscopic surgery in patients with vaginal or cervical lesions.

Enrollment: 34 patients

Sex: Female

Ages: 10 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptomatizing women with suspected narrow vagina.
• Nulliparous women or virgin w
• Vaginal or cervical lesion or foreign body.

Exclusion criteria

• Multiparous women
• Nulliparous women with patulous or lax vaginae were excluded.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Tight vaginoscope

Experimental group

Description:

The vaginoscope was extracted and loaded inside a thick rubber ring before its reinsertion inside the vagina again. To avoid leakage from the center of the thick rubber ring, the vaginoscopy is inserted through a premade central cruciate incision.

Treatment:

Device: Tight vaginoscope