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临床试验/NCT06494982
NCT06494982招募中不适用

The Influence of Augmentation of the Anterior Vaginal Wall With a Vascularized Flap on the Effectiveness of Mesh-augmented Sacrospinous Hysteropexy and Anterior Subfascial Colporrhaphy During Reconstruction of the Pelvic Floor for POP

Saint Petersburg State University, Russia2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
2
主要终点
Objective cure rate

研究概览

简要总结

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.

详细描述

BACKGROUND POP is an epidemiologically widespread condition, occurring in 40-60% of women who have given birth. With all the variety of anatomical defects of the pelvic floor, the most common variant is prolapse of the anterior vaginal wall (cystocele).

Of the currently known surgical methods for the treatment of cystocele, anterior colporrhaphy occupies one of the most key places. However, the high recurrence rate of 7-23%, and according to some authors more than 90%, has led to the development of new techniques. In 1997, M. Cosson proposed the "Plastron" method, the essence of which is to close the defect of the pubocervical fascia by fixing a de-epithelialized flap of the anterior vaginal wall to the tendinous arch of the pelvic fascia and then performing anterior colporrhaphy over it. The method was effective in 93.5% of cases in patients with cystocele. At the same time, apical prolapse is present in many women with cystocele. Apical support is important in maintaining normal pelvic floor anatomy. Patients who undergo anterior vaginal wall repair with concomitant repair of the apical defect have a lower risk of reoperation for POP.

There are various methods for restoring apical defects while preserving the uterus. SSHP is the most studied method and was originally performed using sutures. The use of transvaginal mesh for SSHP remains controversial due to the high risk of mesh-associated complications, although many authors report the safety and high effectiveness of the SSHP method using transvaginal mesh. Despite this, the issue of cystocele recurrence after SSHP (with or without mesh) in combination with anterior colporrhaphy remains unresolved.

PREOPERATIVE ASSESSMENT All patients who meet eligibility criteria will undergo a preoperative assessment: medical history, physical and vaginal examination, assessing pelvic organ prolapse according to Pelvic Organ Prolapse Quantification System (POP-Q). All patients will complete questionnaires validated in Russia: Pelvic Floor Disability Index (PFDI-20), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, short form (PISQ-SF), Patient Global Impression of Improvement (PGI-I).

MATERIALS AND METHODS The investigators hypothesis is that is that the use of a deepithelialized vascularized flap of the anterior vaginal wall when performing mesh-augmented sacrospinous hysteropexy and anterior subfascial colporrhaphy reduces the risks of developing relapses of POP in the anterior compartment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
45 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Objective cure rate

时间窗: 12 months (1 year)

The patient is considered cured if there is no prolapse beyond the hymen and the cervix is above -1 cm according to POP-Q (0-1 stage)

次要结局

  • Observed complications(Measured postoperatively at intervals of 6, 12 months postoperatively, Measured postoperatively at intervals of 6, 12 months postoperatively, up to 100 weeks)
  • Satisfaction with the surgery(Measured postoperatively at intervals of 6, 12 months postoperatively, up to 100 weeks)
  • The impact of treatment on sexual function(Measured postoperatively at intervals of 6, 12 months postoperatively, Measured postoperatively at intervals of 6, 12 months postoperatively, up to 100 weeks)
  • The impact of treatment on the quality of life(Measured postoperatively at intervals of 6, 12 months postoperatively, Measured postoperatively at intervals of 6, 12 months postoperatively, up to 100 weeks)

研究者

发起方
Saint Petersburg State University, Russia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shkarupa Dmitry

MD, PhD; Director, St. Petersburg State University Hospital

Saint Petersburg State University, Russia

研究点 (2)

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