EndometriosisROXWELLNCT05019612
The Role of Expectations on Complaints and Well-being After Endometriosis Surgery in Women
An observational study of Endometriosis and Expectations, run by Helmut Schmidt University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis, Expectations, Laparoscopy
- What is being tested?
- Laparoscopy: A minimal invasive surgery
- Type of treatment
- Surgery or procedure
- How many people
- 395 participants
- Where
- 1 siteGermany
- Study dates
- 25 Aug 2021to 20 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: Women will be selected who are treated in the Frauenklinik an der Elbe.
Who may be able to join
- 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
Who cannot join
- Incomplete excision of endometriosis
- Malignant biopsy result (postoperatively)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Expectations on Complaints and Well-being After Endometriosis Surgery
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.
Read more
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.
Read the 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
- Conditions
- Endometriosis, Expectations, Laparoscopy
- Being tested
- Laparoscopy: A minimal invasive surgery
- Keywords
- cohort study, endometriosis, surgery, laparoscopy, expectation, nocebo, placebo
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopy: A minimal invasive surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| single-group/one cohort | Women with endometriosis, having the clinical indication for laparoscopic endometriosis excision Receives: Procedure: Laparoscopy: A minimal invasive surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Course of Endometriosis related Pain Disability - Pain Disability Index (PDI-D)
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.
Measured: at baseline, seven times consecutive with an interval of four weeks, follow-up 12 months after surgery
Secondary outcomes (4)
Severity of endometriosis-related complaints - self-conducted rating scale (NRScomplaints)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: at baseline, seven times consecutive with an interval of 4 weeks, follow up 12 months after surgery
Current Treatment effects - 'Generic rating scale for treatment effects' (GEEE_ACT)
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.
Measured: Continuous measurement postoperatively, seven times with an interval of four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start25 Aug 2021
- Primary completion20 Jun 2024
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 395 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helmut Schmidt University
- Sponsor type
- University, hospital or other
- Collaborators
- Frauenklinik an der Elbe
- Responsible party
- Principal investigator, Dr. Yvonne Nestoriuc, Helmut Schmidt University
- Investigators
- Yvonne Nestoriuc, Prof. Dr., Principal investigator, Helmut Schmidt University/ University of the Federal Armed Forces Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019612
- Sponsor's protocol ID
- ROXWELL-2021-HH
- Acronym
- ROXWELL
- Status last verified
- Jan 2024
- First submitted
- 16 Aug 2021
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in published articles will be shared after deidentification via a repository. A study protocol is available. Audio records will be deleted, transcripts are available following publications upon reasonable request.
Publications
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.
PubMed 24047450Heisig 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.
PubMed 24953538Nestoriuc 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.
PubMed 27551051Pan 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.
PubMed 31427995Quidde 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.
PubMed 30249191Shedden-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.
PubMed 36397978Nestoriuc 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.
PubMed 32691079Hirsing N, Nestoriuc Y, Buchweitz O, Meyrose AK. Pre-operative expectations in patients with endometriosis - a qualitative interview study. BMC Womens Health. 2025 Apr 28;25(1):209. doi: 10.1186/s12905-025-03686-3.
PubMed 40295982Meyrose 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.
PubMed 39328391Hirsing 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.
PubMed 36599637
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Expectations on Complaints and Well-being After Endometriosis Surgery
- ClinicalTrials.gov ID
- NCT05019612
- Acronym / sponsor ID
- ROXWELL / ROXWELL-2021-HH
- Conditions
- Endometriosis, Expectations, Laparoscopy
- Keywords
- cohort study, endometriosis, surgery, laparoscopy, expectation, nocebo, placebo
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 395 participants (actual)
- Lead sponsor
- Helmut Schmidt UniversityUniversity, hospital or other
- Collaborators
- Frauenklinik an der Elbe
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single-group/one cohort | – | Procedure: Laparoscopy: A minimal invasive surgeryWomen with endometriosis, having the clinical indication for laparoscopic endometriosis excision |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women will be selected who are treated in the Frauenklinik an der Elbe.
Key inclusion criteria (6 listed)
- Adult women (18+)
- Endometriosis related symptoms and complaints
- Clinical indication for surgery/laparoscopy
- Clinically diagnosed endometriosis (postoperatively)
- Informed consent
Key exclusion criteria (2 listed)
- Incomplete excision of endometriosis
- Malignant biopsy result (postoperatively)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopy: A minimal invasive surgeryA 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. | Procedure or surgery | single-group/one cohort |
Primary outcome
Course of Endometriosis related Pain Disability - Pain Disability Index (PDI-D)
Time frame: 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.
4 secondary outcomes
Severity of endometriosis-related complaints - self-conducted rating scale (NRScomplaints)
Time frame: 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)
Time frame: 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)
Time frame: at baseline, seven times consecutive with an interval of 4 weeks, follow up 12 months after surgery
Current Treatment effects - 'Generic rating scale for treatment effects' (GEEE_ACT)
Time frame: Continuous measurement postoperatively, seven times with an interval of four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Background: PubMed 24047450von 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.
- Background: PubMed 24953538Heisig 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.
- Background: PubMed 27551051Nestoriuc 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.
- Background: PubMed 31427995Pan 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.
- Background: PubMed 30249191Quidde 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.
- Background: PubMed 36397978Shedden-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.
- Background: PubMed 32691079Nestoriuc 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.
- Derived from this study: PubMed 40295982Hirsing N, Nestoriuc Y, Buchweitz O, Meyrose AK. Pre-operative expectations in patients with endometriosis - a qualitative interview study. BMC Womens Health. 2025 Apr 28;25(1):209. doi: 10.1186/s12905-025-03686-3.
- Derived from this study: PubMed 39328391Meyrose 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.
- Derived from this study: PubMed 36599637Hirsing 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in published articles will be shared after deidentification via a repository. A study protocol is available. Audio records will be deleted, transcripts are available following publications upon reasonable request.
Related trials for Endometriosis
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
SIBO, Endometriosis
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvonne Nestoriuc, Prof. Dr. principal investigator
Helmut Schmidt University/ University of the Federal Armed Forces Hamburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Expectations, run by Helmut Schmidt University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Course of Endometriosis related Pain Disability - Pain Disability Index (PDI-D) (time frame: at baseline, seven times consecutive with an interval of four weeks, follow-up 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05019612, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.