EndometriosisNCT04669769
Retrospective Analysis of Results of Surgery for Deep Bowel Endometriosis
An observational study of Endometriosis and Deep Endometriosis, run by University Hospital Muenster at 1 site in Germany.
Trial summary
identification of patients operated becaus of bowel endometriosis at the endometriosis center, University Hospital Muenster, Germany, starting 2009, Analysis of Patient history, surgical procedurie, intraoperative complications, postoperative complications, phone call assessing further complications, complaints after… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis, Deep Endometriosis, Bowel Endometriosis
- What is being tested?
- interview
- How many people
- 151 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2019to 4 Dec 2020
- 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 50 years
- Women only
- Adult
Study population: patients treated because of deep Infiltrating bowel endometriosis at the endometriosis Center, University Hospital Muenster, Germany starting 2009
Who may be able to join
- deep Infiltrating endometriosis, surgery with complete or partial resection of bowel endometriosis or conservative Management, Treatment at endometriosis Center University Hospital Muenster, Germany, wants to participate
Who cannot join
- declines participation
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Muenster
Münster, North Rhine-Westphalia, 48149
About this study
Official title: Retrospective Analysis of Outcomes After Surgery for Deep Infiltrating Endometriosis of the Bowel
identification of patients operated becaus of bowel endometriosis at the endometriosis center, University Hospital Muenster, Germany, starting 2009, Analysis of Patient history, surgical procedurie, intraoperative complications, postoperative complications, phone call assessing further complications, complaints after surgery, pregnancy, live birth, additional surgery, spontaneous conception, conception by IUI, ART
- Being tested
- interview
- Keywords
- endometriosis, deep endometriosis, bowel endometriosis, conception, ART, spontaneous conception, pregnancy rate
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interviewOther
telephone interview
| Study group | Role | What they receive |
|---|---|---|
| shaving | patients with DIE and shaving Receives: Other: interview | |
| disc resection | patients with DIE and Disc resection Receives: Other: interview | |
| segmental resection | patients with DIE and segmental resection Receives: Other: interview | |
| multifocal | patients with multifocal DIE having more than one bowel procedure Receives: Other: interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
complications
complications according to Clavien Dindo Classification
Measured: up to 10 years
Secondary outcomes (7)
pregnancy rate
pregancy after surgery
Measured: up to 10 years
live birth
live birth after surgery
Measured: up to 10 years
pain recurrence
pain recurrence after operation
Measured: up to 10 years
disease recurrence
disease recurrence after operation
Measured: up to 10 years
recurrent surgery
recurrent surgery after surgery for bowel endometriosis
Measured: up to 10 years
pregnancy rate with ongoing bowel endometriosis
pregnancy rate with ongoing bowel endometriosis
Measured: up to 10 years
live birth with ongoing bowel endometriosis
live birth with ongoing bowel endometriosis
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start1 Dec 2019
- Primary completion1 May 2020
- Study completion4 Dec 2020
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.
- 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
- Retrospective
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Sebastian Daniel Schäfer, University Hospital Muenster
- Investigators
- Sebastian D Schaefer, MD PhD, Principal investigator, University Hospital Muenster, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669769
- Sponsor's protocol ID
- Schäfer_Endo_DIE_Bowel_Com
- Status last verified
- Dec 2020
- First submitted
- 4 Dec 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: will be shared upon reasonable request and according to regulations
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Outcomes After Surgery for Deep Infiltrating Endometriosis of the Bowel
- ClinicalTrials.gov ID
- NCT04669769
- Acronym / sponsor ID
- Schäfer_Endo_DIE_Bowel_Com
- Keywords
- endometriosis, deep endometriosis, bowel endometriosis, conception, ART, spontaneous conception, pregnancy rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 4 Dec 2020 (actual)
- First posted
- 17 Dec 2020 (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.
identification of patients operated becaus of bowel endometriosis at the endometriosis center, University Hospital Muenster, Germany, starting 2009, Analysis of Patient history, surgical procedurie, intraoperative complications, postoperative complications, phone call assessing further complications, complaints after surgery, pregnancy, live birth, additional surgery, spontaneous conception, conception by IUI, ART
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| shaving | – | Other: interviewpatients with DIE and shaving |
| disc resection | – | Other: interviewpatients with DIE and Disc resection |
| segmental resection | – | Other: interviewpatients with DIE and segmental resection |
| multifocal | – | Other: interviewpatients with multifocal DIE having more than one bowel procedure |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- patients treated because of deep Infiltrating bowel endometriosis at the endometriosis Center, University Hospital Muenster, Germany starting 2009
Key inclusion criteria (1 listed)
- deep Infiltrating endometriosis, surgery with complete or partial resection of bowel endometriosis or conservative Management, Treatment at endometriosis Center University Hospital Muenster, Germany, wants to participate
Key exclusion criteria (1 listed)
- declines participation
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 |
|---|---|---|
| interviewtelephone interview | Other | disc resection, multifocal, segmental resection, shaving |
Primary outcome
complications
Time frame: up to 10 years
complications according to Clavien Dindo Classification
7 secondary outcomes
pregnancy rate
Time frame: up to 10 years
live birth
Time frame: up to 10 years
pain recurrence
Time frame: up to 10 years
disease recurrence
Time frame: up to 10 years
recurrent surgery
Time frame: up to 10 years
pregnancy rate with ongoing bowel endometriosis
Time frame: up to 10 years
live birth with ongoing bowel endometriosis
Time frame: up to 10 years
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 Dec 2020.
- Individual participant dataSharing planned: Undecided. will be shared upon reasonable request and according to regulations
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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.
Sebastian D Schaefer, MD PhD principal investigator
University Hospital Muenster, Germany
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 Deep Endometriosis, run by University Hospital Muenster 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 1 inclusion and 1 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 Dec 2020. 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?
complications (time frame: up to 10 years). 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 17 Dec 2020.