The Role of Expectations on Complaints and Well-being After Endometriosis Surgery in Women

Active, not recruiting

• Conditions: Laparoscopy; Endometriosis; Expectations

• Registration Number: NCT05019612
• Lead Sponsor: Helmut Schmidt University

Brief Summary

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.

Detailed Description

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:

In the proposed study, a sample of 300 women will report pre- and postoperatively about their treatment and symptom expectations, health condition, and other psychological factors that may influence treatment course and outcome after endometriosis surgery. Overall, this monitoring will last 12 months, including one assessment preoperatively (baseline), seven monthly assessments postoperatively, and a follow-up assessment 12 months after endometriosis surgery. All assessments will be conducted online.

Within the scope of an embedded qualitative study, a partial sample of 20 to 30 women will be interviewed preoperatively and postoperatively about their treatment and symptom expectations, fears, and concerns regarding the laparoscopy.

Above that, a second partial sample of 20 women will report on seven consecutive days about their current health condition, and treatment and symptom expectations in their everyday life using ambulatory assessment (smartphone-based measurements).

Objectives:

Firstly, the investigators are interested in the treatment course and outcome and its possible changes over a period of six months after endometriosis surgery. Secondly, the role of pre- and post-operative expectations for treatment course and outcome for women with endometriosis should be determined. Besides expectations, the investigators will finally examine further potential psychological and social predictors for treatment outcome, e.g., prior treatment experiences, state anxiety, depression, pain catastrophization and demographics, in order to optimize endometriosis therapy.

Regarding the embedded qualitative study, the investigators explore and categorize the mentioned treatment- and symptom-related expectations concerning endometriosis surgery (laparoscopy) and psychological factors that potentially improve or harm women's treatment outcome and health condition. The ambulatory assessment offers a monitoring of patients' symptom course in their daily lives and the determination of potential modulators

Study Timeline

• Study First Submitted: 2021-08-16
• Study First Submitted QC: 2021-08-20
• Study Start: 2021-08-25
• Study First Posted: 2021-08-25
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-23
• Last Update Posted: 2024-01-24
• Primary Completion: 2024-06-20
• Study Completion: 2024-06-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

1. Adult women (18+)
2. Endometriosis related symptoms and complaints
3. Clinical indication for surgery/laparoscopy
4. Clinically diagnosed endometriosis (postoperatively)
5. Informed consent
6. Sufficient knowledge of the German language

Exclusion Criteria

1. Incomplete excision of endometriosis
2. Malignant biopsy result (postoperatively)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Course of Endometriosis related Pain Disability - Pain Disability Index (PDI-D)	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.

Secondary Outcome Measures

Name	Time	Method
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	The NRScomplaints Questionnaire assesses the self-reported severity of the five most prevalent endometriosis symptoms (dysmenorrhoea, pelvic pain, dyspareunia, dyschezia, dysuria) by a numeric rating scale with eleven response options (0-10). The overall total score will be examined.
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	The SWEMWBS assesses the self-reported mental well-being using seven statements about thoughts and feelings with five response (1=never to 5=always) options. The total score ranges from 7 to 35, higher sum scores reflect a higher level of mental well-being.
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	The EHP-5 measures the wide range of effects that endometriosis can have on women's lives covering five items with five response options (0=never to 4=always). A higher sum score reflects a higher level of self-reported impairment.
Current Treatment effects - 'Generic rating scale for treatment effects' (GEEE_ACT)	Continuous measurement postoperatively, seven times with an interval of four weeks	The GEEE_ACT assesses the self-reported current treatment effects on endometriosis related complaints using three numeric rating scales with eleven response options (0-10). The total sum score will be examined.

Trial Locations

Locations (1)

Helmut Schmidt University; 🇩🇪 Hamburg, Germany