EndometriosisNCT04669756
Ovariopexy for Adhesion Prevention After Laparoscopic Removal of Endometriosis of the Pelvic Side Wall or the Ovary
A study testing ovariopexy in people with Endometriosis and Adhesion, run by University Hospital Muenster at 1 site in Germany.
Trial summary
prospective randomized Trial comparing ovariopexy over 2, 4 or 6 days vs Placebo after surgery because of endometriosis of the pelvic side wall or the ovary or both Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis, Adhesion, Surgery
- What is being tested?
- ovariopexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 409 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2018to 31 Jan 2021
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult
Who may be able to join
- premenopausal
- wants to participate
- removal of endometriosis of the pelvic side wall or ovary
Who cannot join
- postmenopausal
- cannot give informed consent
- no endometriosis during Operation
- no Opening of pelvic side wall or ovary during the Operation
- pregnant
- breast feeding
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Muenster
Münster, North Rhine-Westphalia, 48149
About this study
prospective randomized Trial comparing ovariopexy over 2, 4 or 6 days vs Placebo after surgery because of endometriosis of the pelvic side wall or the ovary or both
- Conditions
- Endometriosis, Adhesion, Surgery
- Being tested
- ovariopexy, placebo operation
- Keywords
- endometriosis, ovariopexy, adhesion prevention, laparoscopy, complications, AMH
- Medical subject headings
- Endometriosis, Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ovariopexyProcedure or surgery
if endometriosis was removed from the pelvic side wall or the ovary or both leading to an open wound adjacent to the ovary, ovariopexy was performed on both sides using a transabdominal-transovarian suture being tied extracorporeally on the patients Skin leading to uplifting of the ovary to the abdominal wall
placebo operationProcedure or surgery
in arm D sutures are transabdominal only
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | ovariopexy for 2 days Receives: Procedure: ovariopexy |
| B | Experimental | ovariopexy for 4 days Receives: Procedure: ovariopexy |
| C | Experimental | ovariopexy for 6 days Receives: Procedure: ovariopexy |
| D | Placebo comparator | Placebo Operation for 2 days Receives: Procedure: placebo operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of postoperative ovarian adhesions
prevalence of postoperative ovarian adhesions
Measured: 3 months after operation
Secondary outcomes (3)
postoperative pain
postoperative pain (NRS)
Measured: daily during postoperative hospitalisation and at follow up visit after 3 months
AMH
AMH level
Measured: at follow up visit after 3 months
postoperative infectious complications
postoperative infectious complications
Measured: up to 3 months after operation
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 Apr 2018
- Primary completion8 Jan 2021
- Study completion31 Jan 2021
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 409 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
- NCT04669756
- Sponsor's protocol ID
- Schäfer_Endo_Ovariopexie
- Status last verified
- Apr 2021
- First submitted
- 4 Dec 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: data can be shared upon reasonable request and according to regulations
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ovariopexy for Adhesion Prevention After Laparoscopic Removal of Endometriosis of the Pelvic Side Wall or the Ovary
- ClinicalTrials.gov ID
- NCT04669756
- Acronym / sponsor ID
- Schäfer_Endo_Ovariopexie
- Conditions
- Endometriosis, Adhesion, Surgery
- Keywords
- endometriosis, ovariopexy, adhesion prevention, laparoscopy, complications, AMH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 409 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 8 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (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.
prospective randomized Trial comparing ovariopexy over 2, 4 or 6 days vs Placebo after surgery because of endometriosis of the pelvic side wall or the ovary or both
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: ovariopexyovariopexy for 2 days |
| B | Experimental | Procedure: ovariopexyovariopexy for 4 days |
| C | Experimental | Procedure: ovariopexyovariopexy for 6 days |
| D | Placebo comparator | Procedure: placebo operationPlacebo Operation for 2 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- premenopausal
- wants to participate
- removal of endometriosis of the pelvic side wall or ovary
Key exclusion criteria (6 listed)
- postmenopausal
- cannot give informed consent
- no endometriosis during Operation
- no Opening of pelvic side wall or ovary during the Operation
- pregnant
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 |
|---|---|---|
| ovariopexyif endometriosis was removed from the pelvic side wall or the ovary or both leading to an open wound adjacent to the ovary, ovariopexy was performed on both sides using a transabdominal-transovarian suture being tied extracorporeally on the patients Skin leading to uplifting of the ovary to the abdominal wall | Procedure or surgery | A, B, C |
| placebo operationin arm D sutures are transabdominal only | Procedure or surgery | D |
Primary outcome
prevalence of postoperative ovarian adhesions
Time frame: 3 months after operation
prevalence of postoperative ovarian adhesions
3 secondary outcomes
postoperative pain
Time frame: daily during postoperative hospitalisation and at follow up visit after 3 months
AMH
Time frame: at follow up visit after 3 months
postoperative infectious complications
Time frame: up to 3 months after operation
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 28 Apr 2021.
- Individual participant dataSharing planned: Undecided. data can 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?
A study testing ovariopexy in people with Endometriosis and Adhesion, 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 3 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 28 Apr 2021. 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. Some participants in this study may receive a placebo. 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?
prevalence of postoperative ovarian adhesions (time frame: 3 months after operation). 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 28 Apr 2021.