The Influence of Using Vascularized Vaginal Flap on the Efficacy of Mesh-augmented Sacrospinous H… (NCT06494982) | Clinical Trial Compass
RecruitingNot Applicable
The Influence of Using Vascularized Vaginal Flap on the Efficacy of Mesh-augmented Sacrospinous Hysteropexy
Russia60 participantsStarted 2024-05-01
Plain-language summary
This is a prospective randomized controlled trial designed to compare the effectiveness and safety of two methods of pelvic floor reconstruction in patients with pelvic organ prolapse (POP): sacrospinous hysteropexy (SSHP) with synthetic mesh, vascularized anterior vaginal wall flap, anterior colporrhaphy, and sacrospinous hysteropexy with synthetic mesh. , anterior colporrhaphy, as well as the impact of surgery on quality of life.
Who can participate
Age range45 Years – 80 Years
SexFEMALE
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Inclusion Criteria:
* The subject is a woman with anterior and apical compartment pelvic organ prolapse
* The age of a subject is 45-80 years
* Leading point of prolapse is at the level of the hymen or distal to the hymen (Ba, C\>=1 according to POP-Q classification)
* The subject gave written consent to participate in the study
* The subject is able to evaluate the risks of the treatment and make an independent decision on participation in the study
* The subject is able to fill up validated questionnaires and come to the control visit after the surgery
Exclusion Criteria:
* The subject has an active urinary tract infection or skin infection in the region of surgery or acute infectious disease
* The subject had prior hysterectomy
* The subject has previously diagnosed or currently active cancer
* The subject has chronic pelvic pain
* The subject has cervical elongation
* The subject has gynecological diseases (recurrent uterine bleeding, endometrial hyperplasia, the presence of atypical cells in cervical smears, adenomyosis, multiple uterine myoma)
* The subject is planning pregnancy
* The subject is unable to visit postoperative check-ups
* Refusal from participation.