search
Back to results

Balloon Vaginoplasty for Treatment of Vaginal-aplasia

Primary Purpose

Vaginal Abnormality

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
laparoscopy
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vaginal Abnormality

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    fractionated intraumbilical microports group

    fully monitored entry group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    The Operative time
    duration of surgery will be calculated from start of laparoscopy

    Secondary Outcome Measures

    Full Information

    First Posted
    May 15, 2022
    Last Updated
    May 18, 2022
    Sponsor
    Assiut University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05381584
    Brief Title
    Balloon Vaginoplasty for Treatment of Vaginal-aplasia
    Official Title
    Balloon Vaginoplasty; Fully Monitored Entry Versus Fractionated Intraumbilical Microports for Treatment of Vaginal-aplasia; A Quasi Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2022 (Anticipated)
    Primary Completion Date
    September 2023 (Anticipated)
    Study Completion Date
    October 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vaginal Abnormality

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    fractionated intraumbilical microports group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    fully monitored entry group
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    laparoscopy
    Intervention Description
    laparoscopy will be done under anesthesia for management for cases with blind vagina
    Primary Outcome Measure Information:
    Title
    The Operative time
    Description
    duration of surgery will be calculated from start of laparoscopy
    Time Frame
    1 hour

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Learn more about this trial

    Balloon Vaginoplasty for Treatment of Vaginal-aplasia

    We'll reach out to this number within 24 hrs