跳至主要内容
临床试验/NCT03744143
NCT03744143已完成不适用

Comparison of Surgical Techniques for the Eradication of Deep Infiltrating Endometriosis of the Vagina: a Case-control Study

IRCCS Azienda Ospedaliero-Universitaria di Bologna4 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2019年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
84
试验地点
4
主要终点
Operative time

研究概览

简要总结

Multicentric retrospective study about the comparison of two different techniques of vaginal breach suturing after eradication surgery for deep infiltrating endometriosis and the surgical approaches (laparoscopic or vaginal) in terms of surgical, clinical and functional outcomes.

详细描述

Treatment of vaginal endometriosis can be successfully performed by vaginal or laparoscopic approach.

The results of the surgical treatment confirm its validity with regard to the reduction of dyspareunia in the short to medium term but show less efficacy in the long follow-up. The long-term impact of surgery on sexual function may be influenced by multiple factors, such as recurrence of symptomatic or anatomical disease, preservation of autonomic nerve fibers responsible for the arousal and genital sensitivity and residual vaginal length. These factors are potentially dependent on the surgical approach performed to treat vaginal endometriosis.

Particular importance as a surgical step assumes the closing phase of the vaginal defect that can be performed through a transverse or longitudinal suture. The longitudinal suture could guarantee, theoretically, a greater residual vaginal length and a better sexual function in the postoperative period than the vaginal closure by transversal suture, as demonstrated in previous studies about the suture techniques of vaginal cuff after hysterectomy.

Up to date, there are no studies comparing surgical, clinical and functional outcomes of the vaginal suture neither the two surgical approaches (laparoscopic or vaginal) for vaginal endometriosis eradication.

研究设计

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

入排标准

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

入选标准

  • Clinical diagnosis of vaginal endometriosis
  • Women undergoing surgical removal with complete endometriotic lesions involving the vagina
  • Informed consent for the processing of personal data for scientific purposes

排除标准

  • History of previous or ongoing neoplastic pathology
  • Patients committed to hysterectomy
  • Previous vaginal surgery
  • Not complete eradicating surgery
  • Vaginism-vulvodynia
  • Psychiatric disorders
  • Genital prolapse
  • Surgical menopause or spontaneous or pharmacological menopause

结局指标

主要结局

Operative time

时间窗: Intraoperative

To compare the surgical techniques of vaginal endometriotic nodule removal considering the operative time

次要结局

  • Complication rate(up to 30 days after surgery; from date of surgery until the date of first documented complication, assessed up to 30 days)
  • Evaluation of dyspareunia recurrence rate(Up to 6 months after surgery)
  • Evaluation of disease recurrence rate(Up to 6 months after surgery; from date of surgery until the date of first clinical or trans-vaginal/abdominal ultrasound documented recurrence, assessed up to 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Mabrouk

Principal investigator

IRCCS Azienda Ospedaliero-Universitaria di Bologna

研究点 (4)

Loading locations...

相似试验