The Use of vNOTES Approach in Elective Bilateral Salpingectomy for Sterilization as a Cancer Prevention Strategy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Patient satisfaction at first week
研究概览
简要总结
Objective: To compare the vNOTES approach versus conventional laparoscopic approach to be used in elective bilateral salpingectomy for sterilisation as an opportunistic cancer prevention strategy.
Study design: Prospective cohort, two-centred trial. Study population: All women aged over 18 who are planned to undergo for definitive surgical sterilisation regardless of parity with a non-prolapsed uterus.
Primary outcomes: (1) Patient satisfaction (at 1st week and 1st month of the surgery) measured by The Patient Global Imression of Improvement (PGI-I), (2) Postoperative early pain (Visual Analog Score (VAS) at 6th and 24th hours of the surgery).
Secondary outcomes: (1) Conversion to laparoscopy or laparotomy, (2) duration of the procedure, (3)total amount of analgesics used, (4) New-onset dyspareunia at first coitus measured by the Pain subdomain of Female Sexual Function Index (FSFI), (5) intraoperative complications, (6) postoperative complications
详细描述
Women who are indicated or seek for surgical sterilisation are routinely offered salpingectomy rather than tubal ligation for cancer prevention purposes as a local protocol. Those patients will be offered for vNOTES approach after detailed patient counselling and will be enrolled to the study upon acceptation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged over 18 years regardless of parity with a non-prolapsed uterus
- •Patients who are indicated or seek for definitive surgical sterilisation
- •Patients who prefers salpingectomy over tubal ligation after considering its possible cancer prevention effect
- •Written informed consent obtained prior to surgery
排除标准
- •Any malignancy
- •Suspected rectovaginal endometriosis
- •History of pelvic inflammatory disease, pouch of Douglas abscess
- •Being Virgo or Pregnant
- •Failure to provide written informed consent prior to surgery
结局指标
主要结局
Patient satisfaction at first week
时间窗: The first week after the surgical procedure
Patient satisfaction will be measured with Patient Global Impression of Improvement (PGI-I). It is scored as: Very much better (1), Much better (2), A little better (3), No change (4), A little worse (5), Much worse (6), Very much worse (7). Patient reported as Very much better or much better will be regarded as satisfied.
Postoperative pain at 6th hours
时间窗: At the 6th hours after the surgical procedure
Postoperative pain scores will be measured with using Visual Analogue Score (VAS) as self-reported by the participating women. The VAS scores range from 0= no pain to 10= worst imaginable pain.
Patient satisfaction at first month
时间窗: The first month after the surgical procedure
Patient satisfaction will be measured with Patient Global Impression of Improvement (PGI-I). It is scored as: Very much better (1), Much better (2), A little better (3), No change (4), A little worse (5), Much worse (6), Very much worse (7). Patient reported as Very much better or much better will be regarded as satisfied.
Postoperative pain at 24th hours
时间窗: At the 24th hours after the surgical procedure
Postoperative pain scores will be measured with using Visual Analogue Score (VAS) as self-reported by the participating women. The VAS scores range from 0= no pain to 10= worst imaginable pain.
次要结局
- Intraoperative complications(Intraoperative)
- Duration of the surgical procedure(Intraoperative)
- Conversion(Intraoperative)
- Dyspareunia(At 1st month after the surgical procedure)
- Need of Analgesics(Postoperative, 24 hours)
- Postoperative complications(Postoperative, in the first month of the surgery)
研究者
Murat Yassa
Principal investigator
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital