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

Phase 2

Completed

• Conditions: Endosalpingiosis
• Interventions: Device: Tight vaginoscope

• Registration Number: NCT03024242
• Lead Sponsor: Assiut University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Primary Completion: 2016-12
• Status Verified: 2017-01
• Study Completion: 2017-01
• Study First Submitted: 2017-01-15
• Study First Submitted QC: 2017-01-15
• Study First Posted: 2017-01-18
• Last Update Submitted: 2017-01-23
• Last Update Posted: 2017-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tight vaginoscope	Tight vaginoscope	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.

Primary Outcome Measures

Name	Time	Method
The success rate of the procedure	20 minutes

Secondary Outcome Measures

Name	Time	Method
The satisfaction rate by satisfaction score	20 minutes

Trial Locations

Locations (1)

Women Health Hospital - Assiut university; 🇪🇬 Assiut, Egypt