Comparison of Surgical Techniques for the Eradication of Deep Infiltrating Endometriosis of the Vagina: a Case-control Study
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
- 否
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
Mohamed Mabrouk
Principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
