The Role of Expectations on Complaints and Well-being After Endometriosis Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 395
- 试验地点
- 1
- 主要终点
- Course of Endometriosis related Pain Disability - Pain Disability Index (PDI-D)
研究概览
简要总结
Endometriosis is a prevalent disease in women of procreative age. Most endometriosis patients are affected in their daily life by complaints such as chronic pelvic pain, dysmenorrhoea, infertility, or pain during sexual intercourse. Yet, its etiology is poorly understood. Although laparoscopy is well known as the gold standard for treating endometriosis, 20-30% of treated women still show persistent complaints following successful laparoscopy.
It has been widely recognized that expectations profoundly affect treatment courses and outcomes in many different health conditions. Additionally, evidence suggests that optimizing preoperative expectations can improve post-operative outcomes such as disability and return to work.
The objective of this study is to investigate whether expectations also affect treatment course and outcome in women after endometriosis surgery. For this purpose, the investigators conduct a mixed-method observational cohort study to gather data on psychological factors, particularly treatment and symptom-related expectations, as well as complaints and well-being of patients after surgery. A sample of N = 300 women will be asked pre- and postoperatively to evaluate these psychological factors and indicators of treatment course and outcome. Overall, the study will last 12 months, including one assessment preoperatively (baseline), seven monthly assessments postoperatively, and a follow-up assessment 12 months after endometriosis surgery.
The study aims to determine potential interactions between aforementioned psychological factors, their influence on the postoperative health, and the long- and short-term symptom course of patients with endometriosis. The study results will provide a better understanding of the symptom- and treatment course in women with endometriosis and subsequently supply clinical approaches to optimize treatment of endometriosis.
详细描述
Rationale:
According to the evidence-based S2-treatment guidelines for endometriosis, laparoscopy is the method of choice to remove endometriosis and is associated with considerable symptom improvement. However, 20-30% of treated women (so-called non-responders) still report symptoms and impairments after surgery; this is not explainable by laparoscopy itself or a recurrence of endometriosis. Relevant psychosocial predictors are higher age and pain catastrophization, though both only explain a small amount of persistent symptoms and impairments. This indicates a potential role of other psychological factors influencing treatment outcome, such as expectations.
Evidence for this assumption is provided by placebo-response rates of 30% in women who had a sham endometriosis surgery and even reported symptom improvements after diagnostic (sham) laparoscopy. Concerning other gynaecological settings, research already implies that expectations have a remarkable impact on treatment outcome and quality of life in women with breast cancer. Likewise, the role of expectations could be important for the optimal treatment of endometriosis.
However, there is no study examining the role of expectations on treatment outcomes in women with endometriosis to date. Therefore, this study investigates the influence of expectations and other psychological factors on complaints and well-being of patients after surgery in women with endometriosis.
Method:
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult women (18+)
- •Endometriosis related symptoms and complaints
- •Clinical indication for surgery/laparoscopy
- •Clinically diagnosed endometriosis (postoperatively)
- •Informed consent
- •Sufficient knowledge of the German language
排除标准
- •Incomplete excision of endometriosis
- •Malignant biopsy result (postoperatively)
研究组 & 干预措施
single-group/one cohort
Women with endometriosis, having the clinical indication for laparoscopic endometriosis excision
干预措施: Laparoscopy: A minimal invasive surgery (Procedure)
结局指标
主要结局
Course of Endometriosis related Pain Disability - Pain Disability Index (PDI-D)
时间窗: at baseline, seven times consecutive with an interval of four weeks, follow-up 12 months after surgery
The PDI-D assesses the self-reported disability by endometriosis symptoms using a numeric rating scale with eleven response options (0-10). The overall total score will be calculated by gathering all seven items. The course of endometriosis related pain disability over the measurement points will be analysed as the primary outcome.
次要结局
- Current Treatment effects - 'Generic rating scale for treatment effects' (GEEE_ACT)(Continuous measurement postoperatively, seven times with an interval of four weeks)
- Severity of endometriosis-related complaints - self-conducted rating scale (NRScomplaints)(at baseline, seven times consecutive with an interval of 4 weeks, follow up 12 months after surgery)
- Mental well-being - Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS)(at baseline, seven times consecutive with an interval of four weeks, follow up 12 months after surgery)
- Health related quality of life - Endometriosis Health Profile (EHP-5)(at baseline, seven times consecutive with an interval of 4 weeks, follow up 12 months after surgery)
研究者
Dr. Yvonne Nestoriuc
Prof.
Helmut Schmidt University