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

• Sponsor: Assiut University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03024242
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arm: 1
• Duration (Months): 30.1
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endosalpingiosis	Device: Tight vaginoscope	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Study Start Date: Jul 1, 2014
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: Tight vaginoscope

Outcome Measures

Primary Outcome Measures

1. The success rate of the procedure [20 minutes]

Secondary Outcome Measures

1. The satisfaction rate by satisfaction score [20 minutes]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Women Health Hospital - Assiut university	Assiut		Egypt	71111

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohammed Khairy Ali, Lecturer, Assiut University
• ClinicalTrials.gov Identifier: NCT03024242
• Other Study ID Numbers: TVS
• First Posted: Jan 18, 2017
• Last Update Posted: Jan 24, 2017
• Last Verified: Jan 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes

Study Results

No Results Posted as of Jan 24, 2017