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临床试验/NCT05628831
NCT05628831招募中不适用

COMPARISON BETWEEN AUTOLOGOUS TISSUE RECONSTRUCTION USING vNOTES AND TRADITIONAL SURGERY IN TREATMENT OF PELVIC ORGAN PROLAPSE

General Hospital Zadar2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2023年3月18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
56
试验地点
2
主要终点
Traditional surgery vrs vNOTES PREFAP

研究概览

简要总结

The goal of this randomized, non blind, one center study is to compare the efficacy of vNOTES (vaginal natural orifice transluminal surgery) and traditional vaginal operation between the two groups by determining the risk of re-operation for anterior, posterior or apical prolapse within the study period.

Participants with a POP-Q (Pelvic Organ Prolapse Quantification) of 3 or 4 and an indication for hysterectomy and prolapse repair will be selected and randomly divided in two groups. One group will be operated with standard technique for pelvic organ prolapse and in the other autologous graft will be used using vNOTES ICIQ-LUTSqol (International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module) and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire IUGA revised (PISQ-IR) will be used as a subjective measurement of operative treatment.

Objective evaluation of the effect of postoperative results will be done using transperineal ultrasound before operation, 6 and 12 months after procedure.

EXPECTED CONTRIBUTION: In this research we will evaluate the feasibility and surgical outcome of vaginal NOTES (vNOTES) prolapse repair using posterior rectus fascia (PREFAP- Posterior Rectus Fascia Prolapse repair)

详细描述

All patients will be operated by the same surgeon. Antibiotic prophylaxis will be given pre-operatively according hospital protocols 30 minute before surgery. Surgery will be performed under general anesthesia in the lithotomy position with legs in stirrups The following peri-operative and patient data will be collected and analyzed: preoperative POP- Q, body mass index (BMI), age, parity, history of vaginal delivery, previous pelvic surgery, total operating time, estimated bloodloss, serum hemoglobin (Hb) drop (change between preoperative Hb and postoperative Hb 1 day after surgery), peri-operative complications, post- operative pain score and POP-Q after 6 and 12 months.

The ICIQ-LUTSqol questionnaire (International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module) is a psychometrically robust patient- completed questionnaire evaluating quality of life (QoL) in urinary incontinent patients with particular reference to social effects. It has 20 items to response with overall score between 19- 76 indicating increased impact on quality of life with greater values.

Subjective surgical outcome was measured using the Patient Global Impression of Improvement (PGI-I), which is a validated tool as a global index of response to prolapse surgery. The PGI-I is a seven-scale response for women comparing the postoperative condition with the pre-operative state, 1 being very much better and 7 being very much worse.

The women's prolapse symptoms and their impact will be evaluated before surgical treatment. A subjective assessment of the prolapse was made using Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire IUGA revised (PISQ-IR) before and 12 months after treatment. The PISQ-IR is designed as a condition-specific measure of sexual function in women with pelvic floor dysfunction, including urinary and anal incontinence and pelvic organ prolapse. It consists on 18-21 questions depending weather respondent indicates having a sexual partner or not. The cutoff score of 2.68 for PISQ-IR Summary Score allowed to diagnose sexual dysfunction in sexually active women with pelvic floor disorders.

Pelvic floor ultrasound will be performed before the operation and at 6 and 12 months after the operation. The inspection methods are as follows: Before the inspection, patients emptied the stool and moderately filled the bladder. The following parameters will be measured in resting state using the maximal Valsalva maneuver: Posterior vesicourethral angle (PVA):This included the angle between the proximal urethra and posterior wall of the bladder. Urethral tilt angle: This included the angle between the proximal urethra and vertical axis of the human body. Value is negative if the urethral axis deviated to the ventral side, and the value was positive when it is deviated to the dorsal side. Postoperative rotation angle of the urethra (UR): This refers to the difference in PVA between the Valsalva state and resting state. Bladder neck descent (BND): This refers to the vertical displacement of the bladder neck between the Valsalva state and resting state.

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
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • patients older than 18 years old with no desire to preserve fertility, POP-Q 3 or 4 stage of prolapse with indication for hysterectomy (abnormal uterine bleeding, enlarged fibrous uterus, premalignant cervical findings)

排除标准

  • Virginity, pregnancy, acute urinary infection were considered contraindications; malignancy, previous PID or rectal surgery. Rectovaginal endometriosis. Contraindication for general anaesthesia, pneumoperitoneum or Trendelenburg position. Previous pelvic radiotherapy

结局指标

主要结局

Traditional surgery vrs vNOTES PREFAP

时间窗: 1 year

Compare the efficacy of vNOTES autograft repair and traditional surgery between the two groups by determining the risk of reoperation for anterior, posterior or apical prolapse within the study period

次要结局

  • Learning curve(1 year)
  • Complications(1 year)
  • Ultrasound measurement(1 year)
  • QoL(1 year)
  • Subjective pelvic floor outcomes(1 year)

研究者

发起方
General Hospital Zadar
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luka Matak M.D.

univ.mag spec Luka Matak M.D.

General Hospital Zadar

研究点 (2)

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