Endometriosis OvaryDIENCT06207448
Deep Infiltrating Endometriosis : Laparoscopic Nerve-sparing Surgery and Use of Neutral Argon Plasma
An observational study of Endometriosis Ovary, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Medical treatment of endometriosis has a suspensive and sometimes incomplete effect on the symptoms, making surgical treatment necessary. The aim of surgical treatment of deep endometriosis is to restore normal anatomy and functional integrity. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis Ovary
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2022to 6 Jun 2022
- 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: Adult woman (≥18 years old) who benefited from treatment by nerve-sparing surgery and the use of neutral argon plasma in the context of symptomatic deep pelvic endometriosis at the Strasbourg University Hospital during 2021
Who may be able to join
- Adult woman (≥18 years old)
- Patient who benefited from treatment by nerve-sparing surgery and the use of neutral argon plasma in the context of symptomatic deep pelvic endometriosis at the Strasbourg University Hospital during 2021
- Patient who did not express, after information, the reuse of her data for the purposes of this research.
Who cannot join
- Patient who expressed her opposition to participating in the study
- Patient under legal protection, under guardianship or under curatorship
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Gynécologie Obstétrique - CHU de Strasbourg - France
Strasbourg, 67091
About this study
Medical treatment of endometriosis has a suspensive and sometimes incomplete effect on the symptoms, making surgical treatment necessary. The aim of surgical treatment of deep endometriosis is to restore normal anatomy and functional integrity. Resection of deep endometriosis lesions is recommended to relieve pain, gynecological and digestive symptoms, but rarely urinary disorders. Nerve-sparing surgery, when feasible, reduces post-operative dysuria by sparing the lower hypogastric plexus.
The major limitations of these surgical procedures are the experience of the surgeon and the extent of the disease. Acquiring the surgical techniques and skills necessary to carry out these types of procedures is essential to providing optimal patient care.
- Conditions
- Endometriosis Ovary
- Keywords
- Endometriosis Ovary, Laparoscopic Surgery, Laparoscopic Surgical Procedure, Schwanoma
What is being measured
The primary outcome is the main question the study is designed to answer.
To retrospectively describe the minimally invasive management of deep pelvic endometriosis using nerve-sparing surgery and the use of neutral argon plasma for extensive endometriotic lesions by laparoscopy
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start1 Apr 2022
- Primary completion1 Jun 2022
- Study completion6 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometriosis OvaryStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207448
- Sponsor's protocol ID
- 8501
- Acronym
- DIE
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Infiltrating Endometriosis : Laparoscopic Nerve-sparing Surgery and Use of Neutral Argon Plasma
- ClinicalTrials.gov ID
- NCT06207448
- Acronym / sponsor ID
- DIE / 8501
- Conditions
- Endometriosis Ovary
- Keywords
- Endometriosis Ovary, Laparoscopic Surgery, Laparoscopic Surgical Procedure, Schwanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 6 Jun 2022 (actual)
- First posted
- 17 Jan 2024 (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.
Medical treatment of endometriosis has a suspensive and sometimes incomplete effect on the symptoms, making surgical treatment necessary. The aim of surgical treatment of deep endometriosis is to restore normal anatomy and functional integrity. Resection of deep endometriosis lesions is recommended to relieve pain, gynecological and digestive symptoms, but rarely urinary disorders. Nerve-sparing surgery, when feasible, reduces post-operative dysuria by sparing the lower hypogastric plexus.
The major limitations of these surgical procedures are the experience of the surgeon and the extent of the disease. Acquiring the surgical techniques and skills necessary to carry out these types of procedures is essential to providing optimal patient care.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Adult woman (≥18 years old) who benefited from treatment by nerve-sparing surgery and the use of neutral argon plasma in the context of symptomatic deep pelvic endometriosis at the Strasbourg University Hospital during 2021
Key inclusion criteria (3 listed)
- Adult woman (≥18 years old)
- Patient who benefited from treatment by nerve-sparing surgery and the use of neutral argon plasma in the context of symptomatic deep pelvic endometriosis at the Strasbourg University Hospital during 2021
- Patient who did not express, after information, the reuse of her data for the purposes of this research.
Key exclusion criteria (2 listed)
- Patient who expressed her opposition to participating in the study
- Patient under legal protection, under guardianship or under curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To retrospectively describe the minimally invasive management of deep pelvic endometriosis using nerve-sparing surgery and the use of neutral argon plasma for extensive endometriotic lesions by laparoscopy
Time frame: up to 2 months
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 13 Mar 2024.
Related trials for Endometriosis Ovary
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Recruiting
Effect of Alcohol Sclerotherapy on Pelvic Pain and Quality of Life in Women With Ovarian Endometriosis
Endometrioma, Ultrasound Therapy; Complications
Recruiting
Argon Plasma Treatment for Ovarian Endometrioma Compared to Standard Cystectomy
Endometriosis
Recruiting
Use of tDCS Stimulation in Neurological and Gynaecological Conditions
Stroke, Spinal Cord Diseases
RecruitingObservational study
The Therapy of Large Endometrioma
Endometrioma, Endometriosis Ovary
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ovary, run by University Hospital, Strasbourg, France at 1 site in France.
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 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 13 Mar 2024. 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 France. 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?
To retrospectively describe the minimally invasive management of deep pelvic endometriosis using nerve-sparing surgery and the use of neutral argon plasma for extensive endometriotic lesions by laparoscopy (time frame: up to 2 months). 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 13 Mar 2024.