Hysterectomy for Benign Gynaecological Disease by Natural Orifice Transluminal Endoscopic Surgery or Laparoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Successful Removal of the Uterus Without Conversion to Another Technique
研究概览
简要总结
Objective: To randomly compare hysterectomy by vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) versus laparoscopy uterus in women with benign gynecological pathology.
Study design: Randomized controlled/single center/single-blinded/parallel-group/non-inferiority/efficacy trial.
Study population: All women aged 18 to 70 years regardless of parity with a non-prolapsed uterus and a benign indication for hysterectomy.
Primary study outcome parameters: successful removal of the uterus by the intended technique.
Secondary outcomes: the proportion of women admitted to the in-hospital ward; postoperative pain scores; the total amount of analgesics used; postoperative infection; per- or postoperative complications; hospital readmission rates; duration of the surgical procedure; incidence and intensity of dyspareunia; sexual wellbeing; health-related quality of life; costs.
详细描述
l1.Objectives of the HALON Trial The primary research questions of this IDEAL stage 2b efficacy trial are as follows: is a vNOTES (vaginal Natural Orifice Transluminal Endoscopic Surgery) hysterectomy at least as effective compared to the standard transabdominal laparoscopic approach (LSC) for removing a non-prolapsed uterus without the need for conversion to an alternative approach? (non inferiority design)
Secondary research questions are:
- Do more women treated by vNOTES prefer to leave the day care unit 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 uterus by vNOTES faster compared to LSC?
- Does a vNOTES cause more pelvic infection or other complications compared to LSC?
- Does a vNOTES result in more hospital readmissions within 6 weeks after 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 after the surgical intervention of a vNOTES compared to LSC? 2. TRIAL DESIGN 2.1. Design A single center, single-blinded, parallel group randomized, non-inferiority efficacy trial.
2.2. Simple pilot randomized trial. 2.3. Time schedule Based upon the mean number of hysterectomies performed annually for benign gynecological disease at the department of Obstetrics and Gynecology of the participating center (168) the investigators estimate that the duration of recruitment will be 12 months. Based upon the follow up (6 months) and the period of analysis/reporting (3 months) the total study period will be 2 years.
2.4. Participating center Department of Obstetrics and Gynecology Imeldahospital Imeldalaan 9 2820 Bonheiden Belgium 3. ELIGIBILITY, CONSENT AND RANDOMIZATION 3.1. Screening and consent prior to surgery All women aged 18 to 70 years, regardless of parity, with a non-prolapsed uterus in need of a hysterectomy for benign indication are eligible for inclusion.
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 non-prolapsed uterus in need of a hysterectomy for benign indication
- •Written informed consent obtained prior to surgery
排除标准
- •History of rectal surgery
- •Suspected rectovaginal endometriosis
- •Suspected malignancy
- •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
- •Failure to provide written informed consent prior to surgery
结局指标
主要结局
Successful Removal of the Uterus Without Conversion to Another Technique
时间窗: Intraoperative
Successful removal of the uterus without conversion to another technique with or without morcellation
次要结局
- Admission in Hospital for at Least One Night Observation(Measured on the day of the surgical intervention)
- Postoperative Pain Scores(The first seven days after the surgical intervention)
- The Use of Analgetic Drugs for Postoperative Pain(The first week after the surgical intervention)
- Hospital Readmission(The first six weeks after the surgical intervention)
- Postoperative Complications(The first six weeks after the surgical intervention)
- Vaginal Pain During Sexual Intercourse at Three Months(At 3 months after the surgical intervention)
- Pelvic Pain During Sexual Intercourse at Six Months(At 6 months after the surgical intervention)
- Direct Costs(Up to 6 weeks postoperative)
- Duration of the Surgical Intervention(Intraoperative)
- Vaginal Pain During Sexual Intercourse at Six Months(At 6 months after the surgical intervention)
- Sexual Well Being(At baseline, 3 months and 6 months after the surgical intervention)
- Postoperative Infection(The first six weeks after the surgical intervention)
- Health-related Quality of Life at Three Months(At 3 months after the surgical intervention)
- Intra- Operative Complications(At the time of the surgical intervention)
- Pelvic Pain During Sexual Intercourse at Three Months(At 3 months after the surgical intervention)
- Health-related Quality of Life at Six Months(At 6 months after the surgical intervention)
研究者
Dr Jan Baekelandt, MD
Dr
Imelda Hospital, Bonheiden