The Role of Expectations on Complaints and Well-being After Endometriosis Surgery in Women
NCT ID: NCT05019612
Last Updated: 2024-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
300 participants
OBSERVATIONAL
2021-08-25
2024-06-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Symptoms and Quality of Life of Patients With Suspected Endometriosis
NCT05624567
Laparoscopic Surgical Management of Endometriosis on Fertility
NCT02481739
Improvement in Quality of Life and Pain Scores After Laparoscopic Management of Deep Infiltrating Endometriosis
NCT04062916
Laparoscopic Therapy of Endometrioma: Sclerotherapy vs Cystectomy in Patients With Unfinished Reproductive Plans
NCT05801523
Laparoscopic Segmental Bowel Resection for Deep Infiltrating Colorectal Endometriosis
NCT00462176
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
single-group/one cohort
Women with endometriosis, having the clinical indication for laparoscopic endometriosis excision
Laparoscopy: A minimal invasive surgery
A low-risk minimal invasive surgery performed in the pelvis using small incisions. With the aid of a laparoscope, the operator views the affected area in real-time. Beyond that, the camera sends images to a video monitor. The operator obtains endometriosis and biopsy samples with small surgical instruments. Before laparoscopy, individuals are provided with a general anaesthetic to relax muscles and prevent pain during surgery.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Laparoscopy: A minimal invasive surgery
A low-risk minimal invasive surgery performed in the pelvis using small incisions. With the aid of a laparoscope, the operator views the affected area in real-time. Beyond that, the camera sends images to a video monitor. The operator obtains endometriosis and biopsy samples with small surgical instruments. Before laparoscopy, individuals are provided with a general anaesthetic to relax muscles and prevent pain during surgery.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
2. Malignant biopsy result (postoperatively)
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Frauenklinik an der Elbe
UNKNOWN
Helmut Schmidt University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. Yvonne Nestoriuc
Prof.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yvonne Nestoriuc, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Helmut Schmidt University/ University of the Federal Armed Forces Hamburg
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Helmut Schmidt University
Hamburg, , Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
von Blanckenburg P, Schuricht F, Albert US, Rief W, Nestoriuc Y. Optimizing expectations to prevent side effects and enhance quality of life in breast cancer patients undergoing endocrine therapy: study protocol of a randomized controlled trial. BMC Cancer. 2013 Sep 18;13:426. doi: 10.1186/1471-2407-13-426.
Heisig SR, Shedden-Mora MC, von Blanckenburg P, Schuricht F, Rief W, Albert US, Nestoriuc Y. Informing women with breast cancer about endocrine therapy: effects on knowledge and adherence. Psychooncology. 2015 Feb;24(2):130-7. doi: 10.1002/pon.3611. Epub 2014 Jun 21.
Nestoriuc Y, von Blanckenburg P, Schuricht F, Barsky AJ, Hadji P, Albert US, Rief W. Is it best to expect the worst? Influence of patients' side-effect expectations on endocrine treatment outcome in a 2-year prospective clinical cohort study. Ann Oncol. 2016 Oct;27(10):1909-15. doi: 10.1093/annonc/mdw266. Epub 2016 Aug 22.
Pan Y, Kinitz T, Stapic M, Nestoriuc Y. Minimizing Drug Adverse Events by Informing About the Nocebo Effect-An Experimental Study. Front Psychiatry. 2019 Jul 25;10:504. doi: 10.3389/fpsyt.2019.00504. eCollection 2019.
Quidde J, Pan Y, Salm M, Hendi A, Nilsson S, Oechsle K, Stein A, Nestoriuc Y. Preventing adverse events of chemotherapy by educating patients about the nocebo effect (RENNO study) - study protocol of a randomized controlled trial with gastrointestinal cancer patients. BMC Cancer. 2018 Sep 24;18(1):916. doi: 10.1186/s12885-018-4814-7.
Shedden-Mora MC, Pan Y, Heisig SR, von Blanckenburg P, Rief W, Witzel I, Albert US, Nestoriuc Y. Optimizing Expectations About Endocrine Treatment for Breast Cancer: Results of the Randomized Controlled PSY-BREAST Trial. Clin Psychol Eur. 2020 Mar 31;2(1):e2695. doi: 10.32872/cpe.v2i1.2695. eCollection 2020 Mar.
Nestoriuc Y, Kleine-Borgmann J. [Appearances are not deceptive: clinical evidence and new research approaches to open-label placebo]. Nervenarzt. 2020 Aug;91(8):708-713. doi: 10.1007/s00115-020-00953-6. German.
Meyrose AK, Basedow LA, Hirsing N, Buchweitz O, Rief W, Nestoriuc Y. Assessment of treatment expectations in people with suspected endometriosis: A psychometric analysis. F1000Res. 2024 Sep 9;13:174. doi: 10.12688/f1000research.145377.2. eCollection 2024.
Hirsing N, Meyrose AK, Buchweitz O, Nestoriuc Y. Do expectations determine postoperative disability in women with endometriosis? Study protocol for a clinical mixed-methods observational cohort study. BMJ Open. 2023 Jan 4;13(1):e067497. doi: 10.1136/bmjopen-2022-067497.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ROXWELL-2021-HH
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.