Balloon Vaginoplasty for Treatment of Vaginal-aplasia

Balloon Vaginoplasty; Fully Monitored Entry Versus Fractionated Intraumbilical Microports for Treatment of Vaginal-aplasia; A Quasi Randomized Controlled Trial

Vaginal aplasia is a congenital anomaly characterized by congenital absence of the vagina with an incidence approximately 1:4,500-6,000. It carries an emotional, sexual, and social embarrassing effect on those women, The primary aim of treatment is creation of a neo vagina for restoration of the ability for vaginal intercourse. There are several techniques for neo vaginal construction with variable satisfaction rates. Most of these procedures are either invasive and technically demanding or require long duration in a very motivated patient

Study Overview

• Status: Not yet recruiting
• Conditions: Vaginal Abnormality
• Intervention / Treatment: Procedure: laparoscopy

Detailed Description

Numerous surgical and nonsurgical procedures with varying degrees of success have been described for correction of the vaginal aplasia, but none have proved to be universally accepted.

Balloon vaginoplasty was first introduced in 2003 by El Saman et al for construction of a naturally lined neo vagina through a laparoscopic.

Technique hosts the triad of a perfect management modality; namely: simplicity, safety and success. The technique acts via mechanical expansion of the vaginal epithelium and underlying tissues at the pre-existing vaginal dimple Being a relatively new modality of management, it went through many refinements to make it much easier and feasible. The cornerstone of refinement always ran around the access to the peritoneal cavity. The latest of which was the fractionated intra umbilical micro ports which have the merits of totally hidden scar at the bottom the umbilicus consequently the best cosmetic outcomes. However, during its insertion process a troublesome partially unmonitored insertion was inevitably observed

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Married Females with vaginal aplasia scheduled for balloon vaginoplasty.

Exclusion Criteria:

• Females who refused to consent for participation in the study.
• Unstable marital relationship.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: fractionated intraumbilical microports group; two 4-5-mm micro ports will be done intra umbilically; a 4-mm scope is inserted through one of them, followed by a 4-mm catheter inserter through the second intra umbilical port.	Procedure: laparoscopy; laparoscopy will be done under anesthesia for management for cases with blind vagina
Experimental: fully monitored entry group; only one 4mm intra umbilical port will be done and a second port at a point of lies 8 cm from midline and 5 cm above anterior superior iliac spine. After performing laparoscopic evaluation of the pelvis the telescope will be moved from the umbilical port to the ancillary port and the catheter loaded inserter will be introduced through the umbilical port its insertion will be fully monitored from the point of entry at the umbilicus until the pelvic floor.	Procedure: laparoscopy; laparoscopy will be done under anesthesia for management for cases with blind vagina

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Operative time	duration of surgery will be calculated from start of laparoscopy	1 hour

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: May 15, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 19, 2022

Study Record Updates

• Last Update Posted (Actual): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: vagioplasty in vaginal aplasia

Drug and device information, study documents

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