跳至主要内容
临床试验/NCT07271862
NCT07271862进行中(未招募)不适用

A Novel Laparoscopic Apical Promontofixation Technique With Simultaneous Perineal Reconstruction for Patients With Symptomatic Pelvic Organ Prolapse

Riga East Clinical University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月29日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
60
试验地点
1
主要终点
Anatomical success after pelvic organ prolapse surgery.

研究概览

简要总结

Pelvic organ prolapse in women is a common gynecological condition worldwide, with prevalence reported by different authors ranging from 15% to 50%. Up to 20% of women require surgical intervention during their lifetime due to genital prolapse or urinary incontinence. Surgical correction of prolapse provides an immediate effect by restoring the anatomical and physiological position of the pelvic organs, while also improving women's daily quality of life. Approximately 80-90% of women report satisfaction with the outcomes of prolapse surgery. However, there is still no global consensus regarding the optimal technique for performing colposacropexy. Multiple surgical approaches are currently in use, which prevents a definitive evaluation of the best method for surgical management of this condition. The classical laparoscopic sacrocolpopexy technique, while effective, does not eliminate the risk of mesh-related complications, particularly when synthetic implants are placed along the full length of the anterior and posterior vaginal walls.

Therefore, there is a strong rationale for developing a novel, simplified surgical approach for prolapse correction, derived from the original laparoscopic apical promontofixation, with simultaneous correction of cystocele and rectocele. This could potentially improve surgical outcomes for patients with pelvic organ prolapse while reducing the risk of complications associated with synthetic mesh implantation.

详细描述

This is a prospective randomized study conducted at Riga East University Hospital (Latvia) and Pauls Stradins Clinical University Hospital (Latvia). Two groups of female patients will be compared. In the first group, patients will undergo laparoscopic reconstructive pelvic organ prolapse surgery using a polypropylene implant according to the 'classical' technique, involving fixation to the levator ani muscle and promontofixation. In the second group, patients will undergo a novel laparoscopic reconstructive pelvic organ prolapse procedure using a polypropylene implant based on a 'modified' technique, consisting of laparoscopic apical promontofixation combined with vaginal and perineal tissue repair using native tissues.

Group1 (Classical technique): Half of the patients will undergo laparoscopic sacrocolpopexy using a polypropylene mesh implant fixed to the cervix and along the entire anterior vaginal wall up to the bladder neck, with additional fixation along the posterior vaginal wall and to the levator ani muscles, ensuring physiological tension by securing the implant proximally to the sacral promontory, precisely to the anterior longitudinal vertebral ligament. Separate intracorporeal nonabsorbable sutures will be placed 1.5-2.0 cm apart.

Group2 (Modified technique): Half of the patients will undergo laparoscopic apical promontofixation combined with simultaneous vaginal and perineal reconstruction using native tissues. The procedure includes placement of a polypropylene implant with distal fixation to the bilateral uterosacral ligaments (according to the MacCall technique) and to the cervix, as well as along the anterior vaginal wall up to the bladder neck, maintaining physiological tension, with proximal fixation to the sacral promontory, precisely to the anterior longitudinal vertebral ligament. A simultaneous colpoperineolevatoroplasty will also be performed. During the laparoscopic stage, separate intracorporeal nonabsorbable sutures will be placed 1.5-2.0 cm apart. During the vaginal stage, posterior colporrhaphy with simultaneous levatoroplasty for rectocele repair will be performed in patients with posterior vaginal wall prolapse or perineal defects.

The following parameters will be analyzed: frequency and severity of intraoperative and postoperative complications (early and late), duration of surgery, length of hospital stay, recurrence rate, sexual activity, quality of life before and after surgery, as well as anatomical and functional outcomes. Anatomical results will be evaluated according to the Pelvic Organ Prolapse Quantification System classification. Functional outcomes will be assessed using standardized questionnaires, including Pelvic Floor Distress Inventory-20, Female Sexual Function Index, and International Consultation on Incontinence Questionnaire, in addition to urodynamic testing. Anatomical and functional results, quality of life, and sexual activity will be analyzed over a 6-month postoperative follow-up period.

Based on the study results, the novel laparoscopic apical promontofixation technique with simultaneous perineal repair using native tissues will be introduced into clinical practice in hospitals providing gynecological care. Furthermore, a new unified clinical protocol will be developed to facilitate practical application, including a simplified diagnostic algorithm based on 4-6 key symptoms, enabling family physicians and outpatient gynecologists to identify women with pelvic organ prolapse and refer them for specialist evaluation and appropriate treatment planning.

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
Single (Participant)

入排标准

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

入选标准

  • Female patients with symptomatic isolated or combined forms of pelvic organ prolapse, corresponding to stage II-IV according to the POP-Q classification.
  • Age between 30 and 80 years.
  • Presence or absence of urinary incontinence symptoms.
  • Preoperatively verified by urodynamics: occult, mild, or severe stress urinary incontinence, or absence thereof.
  • Presence or absence of proctogenic constipation.
  • No prior surgical interventions for pelvic organ prolapse or urinary incontinence.
  • History of supracervical hysterectomy.

排除标准

  • Severe extragenital pathology contraindicating surgical treatment.
  • Malignant pelvic pathology.
  • Asymptomatic patients.
  • Patient refusal to undergo subtotal hysterectomy.

结局指标

主要结局

Anatomical success after pelvic organ prolapse surgery.

时间窗: Before and 6 months after surgery.

Anatomical outcome will be assessed using the Pelvic Organ Prolapse Quantification (POP-Q) system. Success is defined as no prolapse beyond the hymen in any vaginal compartment. Unit of Measure: POP-Q stage (0-4).

次要结局

  • Functional outcome - pelvic floor symptoms.(Before and 6 months after surgery.)
  • Sexual function.(Before and 6 months after surgery.)
  • Postoperative complications.(Early (within 30 days) and late (up to 6 months) after surgery.)
  • Urinary function.(Before and 6 months after surgery.)
  • Length of hospital stay.(7 Days.)
  • Operative time.(3 hours.)

研究者

发起方
Riga East Clinical University Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验