EndometriosisPROCURENCT04204707
Patient Reported Outcomes After Surgery for Rectal Endometriosis
An observational study of Endometriosis and Endometriosis, Rectum, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in 2 countries.
Trial summary
To describe the difference in patient reported outcomes after conservative treatment in comparison to radical rectal surgery in patients with deep endometriosis infiltrating the rectum (up to 15cm from the anus with at least involvement of the muscularis layer) and to determine predictors for radical surgery. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis, Endometriosis, Rectum, Endometriosis-related Pain
- What is being tested?
- PROMS
- How many people
- 294 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 9 Dec 2019to 31 Jul 2025
- 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 to 45 years
- Women only
- Adult
Study population: Women scheduled for a multidisciplinary laparoscopic surgery for rectal endometriosis.
Who may be able to join
- Age: 18 - 45 years (both inclusive)
- BMI <35
- Complaining of infertility and/or pain
- Deep endometriosis infiltrating the rectum on at least one imaging technique up to 15 cm from the anus and involving at least the muscularis layer in depth
Who cannot join
- Refusal of bowel resection/stoma
- History of laparotomy for endometriosis
- (history of) Hysterectomy
- Suspected pelvic malignancy
- Pregnancy
- Impossibility for postoperative follow-up in our hospital
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: PROCURE: Patient Reported Outcomes After Surgery for Deep Endometriosis Infiltrating the Muscular Layer of the Rectum: a Prospective Study
To describe the difference in patient reported outcomes after conservative treatment in comparison to radical rectal surgery in patients with deep endometriosis infiltrating the rectum (up to 15cm from the anus with at least involvement of the muscularis layer) and to determine predictors for radical surgery.
- Being tested
- PROMS
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROMSOther
Patient Reported Outcomes after different types of surgery for rectal endometriosis
| Study group | Role | What they receive |
|---|---|---|
| Conservative surgery | Not described Receives: Other: PROMS | |
| Radical surgery (segmental resection) | Not described Receives: Other: PROMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients experiencing one of the following symptoms at 12 months postoperatively:
- constipation (1 stool/>5 consecutive days)
- frequent bowel movement (≥3 stools/day)
- defecation pain
- anal incontinence (involuntary loss of gas or stools)
- dysuria
- bladder atony requiring self-catheterization
Measured: 12 months postoperatively
The determination of possible risk factors for radical surgery.
based on patient complaints, preoperative imaging techniques and intra operative finding
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start9 Dec 2019
- Primary completion31 Mar 2023
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Semmelweis University
- Responsible party
- Sponsor
- Investigators
- Carla Tomassetti, MD, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204707
- Sponsor's protocol ID
- S62986
- Acronym
- PROCURE
- Status last verified
- Jun 2026
- First submitted
- 16 Dec 2019
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROCURE: Patient Reported Outcomes After Surgery for Deep Endometriosis Infiltrating the Muscular Layer of the Rectum: a Prospective Study
- ClinicalTrials.gov ID
- NCT04204707
- Acronym / sponsor ID
- PROCURE / S62986
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Semmelweis University
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 19 Dec 2019 (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.
To describe the difference in patient reported outcomes after conservative treatment in comparison to radical rectal surgery in patients with deep endometriosis infiltrating the rectum (up to 15cm from the anus with at least involvement of the muscularis layer) and to determine predictors for radical surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative surgery | – | Other: PROMS |
| Radical surgery (segmental resection) | – | Other: PROMS |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women scheduled for a multidisciplinary laparoscopic surgery for rectal endometriosis.
Key inclusion criteria (4 listed)
- Age: 18 - 45 years (both inclusive)
- BMI <35
- Complaining of infertility and/or pain
- Deep endometriosis infiltrating the rectum on at least one imaging technique up to 15 cm from the anus and involving at least the muscularis layer in depth
Key exclusion criteria (6 listed)
- Refusal of bowel resection/stoma
- History of laparotomy for endometriosis
- (history of) Hysterectomy
- Suspected pelvic malignancy
- Pregnancy
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 |
|---|---|---|
| PROMSPatient Reported Outcomes after different types of surgery for rectal endometriosis | Other | Conservative surgery, Radical surgery (segmental resection) |
Primary outcome
The proportion of patients experiencing one of the following symptoms at 12 months postoperatively:
Time frame: 12 months postoperatively
* constipation (1 stool/>5 consecutive days) * frequent bowel movement (≥3 stools/day) * defecation pain * anal incontinence (involuntary loss of gas or stools) * dysuria * bladder atony requiring self-catheterization
The determination of possible risk factors for radical surgery.
Time frame: 3 months postoperatively
based on patient complaints, preoperative imaging techniques and intra operative finding
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 22 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Carla Tomassetti, MD, PhD principal investigator
UZ Leuven
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Endometriosis, Rectum, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in 2 countries.
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 4 inclusion and 6 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 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Hungary. 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?
The proportion of patients experiencing one of the following symptoms at 12 months postoperatively: (time frame: 12 months postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2026.