Are pain symptoms related to endometriosis location?
| ISRCTN | ISRCTN45292433 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45292433 |
| Sponsor | Hospital da Luz Lisboa |
| Funder | Hospital da Luz |
- Submission date
- 17/06/2026
- Registration date
- 19/06/2026
- Last edited
- 19/06/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Endometriosis is a common condition where tissue similar to the lining of the womb grows in other parts of the body. It can cause pain and affect daily life and fertility. Around 10 to 20 in every 100 women of reproductive age are affected.
This study aims to find out whether the type and intensity of pain are linked to where endometriosis is located in the body. It will also explore how symptoms change after surgery and whether different types of scans or surgical findings better match what patients feel.
Who can participate?
Women aged 18 to 50 years who have been diagnosed with endometriosis and are planning to have surgery can take part.
Women cannot take part if they are pregnant, younger than 18 years, older than 50 years, or if endometriosis is not confirmed after surgery.
What does the study involve?
Participants will be asked to complete questionnaires about their symptoms, quality of life, and general health about 1 month before surgery.
During surgery, doctors will record details about the location and extent of endometriosis.
After surgery, participants will complete follow up questionnaires at 6 months, 12 months, and 24 months. These will ask about pain levels, recovery, and quality of life.
Most of the study involves answering questionnaires, which can be completed online or on paper.
What are the possible benefits and risks of participating?
There are no direct medical benefits for participants. However, the results may help doctors better understand endometriosis and improve diagnosis and treatment for future patients.
There are no significant risks because this is an observational study. The main burden is the time needed to complete questionnaires.
Where is the study run from?
The study is run from Hospital da Luz Lisboa in Lisbon, Portugal.
When is the study starting and how long is it expected to run for?
The study is planned to start in July 2026. Recruitment is expected to continue until July 2028, with follow up continuing until July 2030.
Who is funding the study?
The study is funded by Hospital da Luz (Portugal).
Who is the main contact?
Dr Joao Alves at Hospital da Luz Lisboa.
jmiguelalves@gmail.com
Contact information
Principal investigator, Public, Scientific
Avenida Lusiada, 100
Lisbon
1500-650
Portugal
 ORCID ID |
0000-0001-6511-2255 |
|---|---|
| Phone | +351 966125130 |
| jmsalves@hospitaldaluz.pt |
Study information
| Primary study design | Observational |
|---|---|
| Observational study design | Cohort study |
| Scientific title | Are pain symptoms related to endometriosis location? |
| Study objectives | Primary objective: correlation between pain patterns and anatomical distribution of deep endometriosis Secondary objectives: 1. To compare if the MRI ENZIAN description is more related to patient complains comparing it with surgical ENZIAN classification 2. To describe the characteristics of patients with recto-sigmoid endometriosis evaluating the possibility that patients with endometriosis nodule closer to the anus have more symptoms intensity 3. To describe the evolution of symptoms before and after the surgery between different endometriosis patients’ groups exploring the idea that different endometriosis location has different pain evolution /outcomes |
| Ethics approval(s) |
Approved 12/06/2026, Comissão de Ética do Hospital da Luz Lisboa (Hospital da Luz, Comissão de Ética, Lisbon, 1500-650, Portugal; +351217 104 544; learninghealth@hospitaldaluz.pt), ref: lD 866; CES 08/2026 |
| Health condition(s) or problem(s) studied | Endometriosis |
| Methodology | Patients sign the informed consent after surgical indication has been approved by the medical team. Patients will receive pseudonymized questionnaires - before the surgery, 6 months after, 1 year and two years after. Surgeons answer online questionnaires at the date of the surgery and 6 months after. We expect a total duration of recruitment of 2 years and due to the final questionnaire being 2 years we aim for 4 years total duration. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 01/07/2030 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | Female |
| Target sample size at registration | 360 |
| Total final enrolment | 460 |
| Key inclusion criteria | Female patients with endometriosis proposed for surgery |
| Key exclusion criteria | 1. Patients proposed for endometriosis surgery that had no histopathological confirmation of endometriosis in surgical specimen 2. Pregnant patient 3. Younger than 18 years old or older than 50 years old |
| Date of first enrolment | 01/07/2026 |
| Date of final enrolment | 01/07/2028 |
Locations
Countries of recruitment
- Portugal
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1 | 02/02/2026 | 17/06/2026 | No | No |
Additional files
- 49735 Protocol v1 02Feb2026.pdf
- Protocol file
Editorial Notes
19/06/2026: Trial's existence confirmed by Comissão de Ética do Hospital da Luz Lisboa.
