Randomized Study Comparing Endoscopic Transvaginal vNOTES Surgery to Laparoscopy in Terms of Postoperative Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Pain score (VAS)
研究概览
简要总结
The feasibility and safety of laparoscopy are no longer to be demonstrated, especially in the field of gynecology, but this technique often causes post-operative pain. New techniques are being developed to overcome the inconvenience of laparoscopy, notably endoscopic transluminal surgery using a natural orifice (NOTES). It avoids incisions and therefore scarring, and could reduce post-operative pain. It is now developing in the field of transvaginal gynecology (vNOTES).
This study is the first prospective randomized study comparing the vNOTES technique to laparoscopy with postoperative pain assessment for performing a salpingectomy. The hypothesis is that the use of vNOTES transvaginal endoscopic surgery would reduce the post-operative pain of patients compared to laparoscopy in the context of a salpingectomy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •planned surgery procedure : bilateral salpingectomy for outpatient benign indication
- •patients with free, informed and signed consent
排除标准
- •disorders leading to an unacceptable risk of postoperative complications sought during the interrogation of the patient (disorders of blood coagulation, disorders of the immune system, progressive diseases ....)
- •pregnancy or wish for subsequent pregnancy
- •lactating women
- •intervention in the context of pelvic cancer
- •history of uni- or bilateral salpingectomy
- •contraindication to laparoscopy
- •history of rectal surgery
- •endometriosis
- •pelvic inflammatory disease
- •genital infection
- •not eligible for outpatient care
- •associated surgical procedure planned during the intervention (hysterectomy, sub-urethral strip, prolapse cure ...)
- •participation in another interventional research related to the gynecological sphere
- •inability to understand the information given
- •a person not affiliated to a social security scheme, or deprived of liberty, or under guardianship.
结局指标
主要结局
Pain score (VAS)
时间窗: Day 1 (the day after surgery)
Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 10 (unbearable pain)
次要结局
- Surgery complications(Month 1)
- Pain score (VAS)(Day 0 (Hour 6 post surgery))
- ease of performing the technique score (VAS)(Day 0 (30 minutes after surgery))
- patient management costs(month 1)
- pain score (VAS)(Day 7)
- duration of surgery(Day 0 (30 minutes after surgery))
- outpatient care(Day 1)
- dose of morphine(Day 0 (2 hours post surgery))
- duration of analgesic(month 1)
- symptom improvement score(month 1)
- pain score (QDSA)(Day 7)
- dose of analgesic(month 1)
- patient satisfaction score(month 1)
- quality of life score(month 1)