Balloon Vaginoplasty for Treatment of Vaginal-aplasia

NCT05381584 | Unknown

• 1 other identifier: vagioplasty in vaginal aplasia
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Vaginal Abnormality

Outcome Measures

Primary Outcomes (1)

• The Operative time

  duration of surgery will be calculated from start of laparoscopy

  1 hour

Study Arms (2)

fractionated intraumbilical microports group

ACTIVE COMPARATOR

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

fully monitored entry group

EXPERIMENTAL

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

Interventions

laparoscopy PROCEDURE

laparoscopy will be done under anesthesia for management for cases with blind vagina

fractionated intraumbilical microports group; fully monitored entry group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Married Females with vaginal aplasia scheduled for balloon vaginoplasty.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Laparoscopy

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: May 15, 2022
• First Posted: May 19, 2022
• Study Start: July 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: October 1, 2023
• Last Updated: May 19, 2022

Record last verified: 2022-05