Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06508151
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-27
Brief Title:
Neovaginoplasty Using Photoinduced-imine-crosslink Hydrogel in MRKH Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study on the Effectiveness and Safety of Neovaginoplasty Using Photoinduced-imine-crosslink Hydrogel in Patients With Mayer-Rokitansky-Kuster-Hauser Syndrome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Evaluating the effectiveness and safety of neovaginoplasty using photoinduced-imine-crosslink hydrogel in patients with MRKH syndrome by comparing the differences in the degree of squamous epithelialization vaginal length and width and sexual life quality
Detailed Description:
This is a randomized controlled trial Patients meeting the inclusion criteria will be enrolled in this study 1Diagnosed with MRKH syndrome 2Without previous treatments 3Age 18-35 years old 4Voluntary agreement to participate in the study sign the informed consent form and demonstrate good compliance with follow-up
A centralized block randomization will be used to randomly assign patients to ensure that there will be an equal number of patients 11 in the hydrogel group and control group The sample size is 20
Under general anesthesia and catheterized bladder the patient was in the lithotomy position In the connective tissue plane between the bladder and rectum the vestiges of the müllerian ducts were identified With the index finger in the rectum as a direction and protection Hegars dilators of increasing size 45-10 were pushed through the dimples gently After that a double-barreled canal appeared Then the raphe between the canals was incised The neovagina was created According to the randomization a vaginal mold spreaded with hydrogel or not was placed The patients were suggested to wear the vaginal mold continuously over the following 6 months After that they were allowed to have the first sexual intercourse Otherwise the mold wearing time was 1 h daily until they had sexual activity at least twice a week
The primary endpoint is the degree of vaginal squamous epithelialization 1 month 3 months 6 months after surgery The secondary endpoints include neovaginal length and width sexual life quality and surgical complications
A centralized block randomization will be used to randomly assign patients to ensure that there will be an equal number of patients 11 in the hydrogel group and control group The sample size is 20
Under general anesthesia and catheterized bladder the patient was in the lithotomy position In the connective tissue plane between the bladder and rectum the vestiges of the müllerian ducts were identified With the index finger in the rectum as a direction and protection Hegars dilators of increasing size 45-10 were pushed through the dimples gently After that a double-barreled canal appeared Then the raphe between the canals was incised The neovagina was created According to the randomization a vaginal mold spreaded with hydrogel or not was placed The patients were suggested to wear the vaginal mold continuously over the following 6 months After that they were allowed to have the first sexual intercourse Otherwise the mold wearing time was 1 h daily until they had sexual activity at least twice a week
The primary endpoint is the degree of vaginal squamous epithelialization 1 month 3 months 6 months after surgery The secondary endpoints include neovaginal length and width sexual life quality and surgical complications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None