Impact on Quality of Life of Osteopathic Visceral Mobilizations in Patients Undergoing Post-operative ENDOmetriosis Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Quality of life with the EHP-30 questionnaire score
研究概览
简要总结
One of the most common post-operative complications of gynaecological surgery, and in particular endometriosis surgery, is the formation of peritoneal adhesions. After laparotomy, it affects up to 90% of patients. Minimally invasive techniques (such as laparoscopy) reduce the risk of adhesion formation, but cannot totally prevent it. Adhesions can lead to chronic pelvic pain, dyspareunia, digestive disorders and infertility. Various strategies and devices have been developed to try and limit adhesion formation, but their effectiveness has not been fully proven in the literature. The only real treatment for adhesions is adhesiolysis, although adhesions often reform. The quality of surgery remains the best means of preventing adhesion formation. To reduce the morbidity associated with pelvic adhesions, it is essential to develop alternative, non-invasive, anti-adhesive methods such as manual osteopathic visceral mobilization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Woman of legal age
- •Indication for surgery for infiltrating endometriosis
- •Able to give informed consent to participate in research
- •Patient included in NO ENDO (national endometriosis observatory promoted by Clermont-Ferrand University Hospital)
排除标准
- •Indication for surgery for superficial endometriosis
- •Patient of legal age, under guardianship or trusteeship
- •Pregnant or breast-feeding patient
- •Patients not affiliated to the social security system
- •Patients who do not speak French
- •Patients under court protection
- •Simultaneous participation in another study
- •Refusal to participate.
结局指标
主要结局
Quality of life with the EHP-30 questionnaire score
时间窗: 1 year
Percentage change in baseline questionnaire score (EHP-30) between pre-operative visit and 1 year. The EHP-30 contains 30 items and ranges from 0 (best health) to 100 (worst health). The items in the baseline questionnaire are grouped into 5 main sub-domains: pain, control and powerlessness, emotional well-being, social support and self-image.
次要结局
- quality of life with score of the questionnaire GIQLI(pre-operative, 6 months and 12 months)
- quality of life with score of the questionnaire ICIQ-FLUTS(pre-operative, 6 months and 12 months)
- quality of life with score of the questionnaire PCS(pre-operative, 6 months and 12 months)
- quality of life with the sub-domains of the EHP-30 questionnaire(pre-operative, 6 months and 12 months)
- evaluation of the abdominal flexibility(1 year)
- quality of life with score of the questionnaire FSFI(pre-operative, 6 months and 12 months)
- quality of life with score of the questionnaire EHP-30(pre-operative, 6 months and 12 months)
- pelvic pain(pre-operative, 6 hours after surgery, 1 day after surgery, 1 month after surgery, 6 months and 12 months)
- evaluation of the cicatrisation(post operative, 6 months and 12 months)
- Use of additional care(1 year)
- consumption of analgesics and hormonal treatment(1 year)
- fertility(1 year)
- number of days of sick leave(1 year)
- compare patient profiles using the sub-domains of the EHP-30 questionnaire(1 year)
- patient compliance(1 year)