Endometriosis PelvicPRSNCT06313411
How do I Perform a Laparoscopic Removal of a Pelvic Retroperitoneal Schwannoma
An observational study of Endometriosis Pelvic, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Schwannomas are mainly benign tumors, which develop mainly in the skull or in the cervical region. Retroperitoneal location is rare, since it represents between 0.5 and 5% of scwhanomas. The malignant retroperitoneal form is, however, more common than in other locations. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis Pelvic
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 23 Nov 2022to Apr 2024
- 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 patient (≥18 years old) having received treatment at the Strasbourg University Hospital during 2021 for a retro-peritoneal pelvic carcinoma
Who may be able to join
- Adult patient (≥18 years old)
- suffering from symptomatic deep pelvic endometriosis
- having received treatment at the Strasbourg University Hospital during 2021 for a retro-peritoneal pelvic carcinoma
- having not expressed, after information, the reuse of their data for the purposes of this research.
Who cannot join
- Patient who expressed her opposition to participating in the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Gynécologie Obstétrique - CHU de Strasbourg - France
Strasbourg, 67091
Emilie FALLER, MD, 33 3 88 12 63 87, emilie.faller@chru-strasbourg.fr
Alexandre PIFFER, MD, 33 6 71 47 38 61, Alexandre.piffer@yahoo.fr
About this study
Schwannomas are mainly benign tumors, which develop mainly in the skull or in the cervical region. Retroperitoneal location is rare, since it represents between 0.5 and 5% of scwhanomas. The malignant retroperitoneal form is, however, more common than in other locations.
Retroperitoneal schwannoma is often discovered during the exploration of unexplained lumbo-pelvic pain, or in the face of compression of nearby organs. Abdominopelvic CT and magnetic resonance imaging are essential to characterize the mass and verify its extension. The precise diagnosis is based on the pathological examination of the part, and complete surgical excision is the standard treatment.
Acquiring the surgical techniques and skills necessary to carry out these types of procedures is essential to providing optimal patient care.
- Conditions
- Endometriosis Pelvic
- Keywords
- Endometriosis Pelvic, Schwannomas
- Medical subject headings
- Neurilemmoma
What is being measured
The primary outcome is the main question the study is designed to answer.
laparoscopic removal of a retroperitoneal pelvic schwannoma
The aim of this research is to train surgeons to perform laparoscopic removal of a retroperitoneal pelvic schwanoma
Measured: Through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start23 Nov 2022
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometriosis PelvicStudies 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 (estimated)
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
- NCT06313411
- Sponsor's protocol ID
- 8778
- Acronym
- PRS
- Status last verified
- Dec 2023
- First submitted
- 14 Dec 2023
- Last updated
- 15 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 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How do I Perform a Laparoscopic Removal of a Pelvic Retroperitoneal Schwannoma
- ClinicalTrials.gov ID
- NCT06313411
- Acronym / sponsor ID
- PRS / 8778
- Conditions
- Endometriosis Pelvic
- Keywords
- Endometriosis Pelvic, Schwannomas
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 23 Nov 2022 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 15 Mar 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.
Schwannomas are mainly benign tumors, which develop mainly in the skull or in the cervical region. Retroperitoneal location is rare, since it represents between 0.5 and 5% of scwhanomas. The malignant retroperitoneal form is, however, more common than in other locations.
Retroperitoneal schwannoma is often discovered during the exploration of unexplained lumbo-pelvic pain, or in the face of compression of nearby organs. Abdominopelvic CT and magnetic resonance imaging are essential to characterize the mass and verify its extension. The precise diagnosis is based on the pathological examination of the part, and complete surgical excision is the standard treatment.
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 patient (≥18 years old) having received treatment at the Strasbourg University Hospital during 2021 for a retro-peritoneal pelvic carcinoma
Key inclusion criteria (4 listed)
- Adult patient (≥18 years old)
- suffering from symptomatic deep pelvic endometriosis
- having received treatment at the Strasbourg University Hospital during 2021 for a retro-peritoneal pelvic carcinoma
- having not expressed, after information, the reuse of their data for the purposes of this research.
Key exclusion criteria (1 listed)
- Patient who expressed her opposition to participating in the study
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
laparoscopic removal of a retroperitoneal pelvic schwannoma
Time frame: Through study completion, an average of 1 month
The aim of this research is to train surgeons to perform laparoscopic removal of a retroperitoneal pelvic schwanoma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
Related trials for Endometriosis Pelvic
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Recruiting
Impact of Food Supplementation on Quality of Life in Patients With Endometriosis and Pelvic Pain.
Endometriosis (Diagnosis)
Not yet recruitingObservational study
Clinical Impact of Ultrasound Diagnosis in Bowel Endometriosis
Endometriosis, Endometriosis Rectum
RecruitingObservational study
Deep Neural Network Stratification for Use Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)
Endometriosis
Not yet recruiting
Effects of Ashwagandha Supplementation on Quality of Life and Well-Being in Women With Endometriosis
Endometriosis, Quality of Life
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.
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 Pelvic, 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 4 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: status not confirmed, as of the sponsor's last update on 15 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emilie FALLER, MD (33 3 88 12 63 87, emilie.faller@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
laparoscopic removal of a retroperitoneal pelvic schwannoma (time frame: Through study completion, an average of 1 month). 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 15 Mar 2024.