Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05381584 |
| Other study ID # |
vagioplasty in vaginal aplasia |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 2022 |
| Est. completion date |
October 2023 |
Study information
| Verified date |
May 2022 |
| Source |
Assiut University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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
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
