Adnexectomy for Benign Gynaecological Pathology by Natural Orifice Transluminal Endoscopy or Laparoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Successful removal of adnexal mass without spill
研究概览
简要总结
Objective: To compare vNOTES (vaginal Natural Orifice Transluminal Endoscopic Surgery) and established laparoscopic removal of benign adnexal masses Study design: Randomized controlled/single center/single-blinded/parallel-group/non-inferiority/efficacy trial.
Study population: Women aged 18 to 70 years with symptomatic or persistent benign adnexal masses detected by clinical examination and ultrasound.
Randomization: Women will be randomly allocated to undergo one of two techniques for removal of the benign adnexal mass immediately before surgery by using a computer generated randomization list. The investigators will use stratified randomization according to the cyst diameter.
Intervention: Women will be treated by a surgeon who is not blinded to the treatment allocation and who is equally skilled in performing both techniques. In the intervention group a vNOTES technique will be used.
Control: In the control group surgery will be done by a classical laparoscopic technique.
Participants, nursing staff and outcome assessors will be blinded.
Main study parameters/endpoints:
Primary outcomes: successful removal of a benign adnexal mass without spill. Secondary outcomes: the proportion of women discharged the same day based on their own preference; postoperative pain scores using a VAS (Visual Analogue Scale) measured between day 1 till 7 by the participating women following surgery and the total amount of analgesics used as described in the standardized pain treatment protocol between day 1 till 7; postoperative infection defined by lower abdominal pain with fever > 38°C and positive clinical signs or laboratory findings; per- or postoperative complications according to the Clavien- Dindo classification detected during the first six weeks of surgery; duration of the surgical procedure; incidence and intensity of dyspareunia recorded by the participants at 3 and 6 months by self-reporting using a simple questionnaire and VAS scale; sexual wellbeing recorded by the participants at 3 and 6 months by SSFS (Short Sexual Functioning Scale); direct costs associated up to 6 weeks after the surgical intervention with both procedures.
详细描述
- Objectives of the NOTABLE Trial
The primary research questions of this IDEAL stage 2b efficacy trial are as follows: is a vNOTES adnexectomy at least as effective compared to the standard transabdominal laparoscopic approach (LSC) for removing a benign adnexal mass without spill? (non-inferiority design)
Secondary research questions are:
- Do more women treated by vNOTES prefer to leave the hospital on the day of surgery compared to LSC?
- Do women treated by vNOTES suffer from less pain compared to women treated by LSC in the first postoperative week?
- Is the removal of a benign adnexal mass by vNOTES faster compared to LSC?
- Does a vNOTES cause more pelvic infection or other complications compared to LSC?
- Does a vNOTES cause more hospital readmissions within 6 weeks following surgery compared to LSC?
- Does a vNOTES approach result in more women reporting dyspareunia, less sexual wellbeing or less health-related quality of life at 3 or 6 months after surgery when compared to women treated by LSC?
- What are the direct and indirect costs up to 6 weeks of a vNOTES compared to LSC?
TRIAL DESIGN 2.1. Design A single center, single-blinded, parallel group randomized, non-inferiority efficacy trial.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All women aged 18 to 70 years regardless of parity with a symptomatic adnexal mass presumed to be benign based on ultrasound examination by applying the IOTA simple rules
- •All women aged 18 to 70 years regardless of parity with an asymptomatic persistent adnexal mass presumed to be benign based on ultrasound examination by applying the IOTA simple rules
- •Written informed consent obtained prior to surgery
排除标准
- •History of hysterectomy by any technique
- •History of rectal surgery
- •Suspected rectovaginal endometriosis
- •Suspected endometriotic cyst
- •Solid adnexal mass
- •High suspicion of adnexal malignancy based on clinical, ultrasound or biochemical findings
- •History of pelvic inflammatory disease, especially prior tubo-ovarian or pouch of Douglas abscess
- •Active lower genital tract infection e.g. Chlamydia, N. gonorrhoeae
- •Pregnancy
- •Need for other uterine surgical intervention (i.e. endometrial ablation, resection, myomectomy or hysterectomy)
- •Additional pathology necessitating hysterectomy
- •Failure to provide written informed consent prior to surgery
结局指标
主要结局
Successful removal of adnexal mass without spill
时间窗: Intraoperative
The proportion of women successfully treated by removing the adnexal mass without spill, using a dichotomous outcome measure, will be used as a measure of efficacy.
次要结局
- Discharge from the hospital the day of the surgical intervention(Dichotomous outcome measured on the day of the surgical intervention)
- Postoperative infection(The first six weeks after the surgical intervention)
- Health-related quality of life(At baseline, at 3 months and 6 months after the surgical intervention)
- Pain during sexual intercourse(At baseline, 3 months and 6 months after the surgical intervention)
- Duration of the surgical intervention(Intraoperative)
- Direct and indirect costs(Up to 6 weeks postoperative)
- Postoperative pain scores(The first week after the surgical intervention)
- The use of analgesics for postoperative pain(The first week after the surgical intervention)
- Complications(The first six weeks after the surgical intervention)
- Hospital readmission(The first six weeks after the surgical intervention)
- Sexual well being(At baseline, 3 months and 6 months after the surgical intervention)
研究者
Dr Jan Baekelandt, MD
Dr
Imelda Hospital, Bonheiden