Twisted Fallopian TubeTubesNCT04813367
Twisted Fallopian Tubes
An observational study of Twisted Fallopian Tube, run by Hospices Civils de Lyon at 13 sites in 5 countries.
Trial summary
Isolated tubal torsion is a very rare event already in adults (1: 1.5 million women), it remains exceptional in children without being able to find a prevalence in the literature. The causes can be malformative or idiopathic, but even that remains unknown. Read more about this study
- Who is it for?
- Ages Up to 18 years, women only
- Conditions the study is for
- Twisted Fallopian Tube
- What is being tested?
- Surgery of twisted fallopian tubes
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 13 sitesin 5 countries
- Study dates
- Apr 2021to Oct 2021
- 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 Up to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Girl younger than 18 with isolated tubal torsion. Girl above 18 and tubal torsion associated with ovary torsion are excluded.
Who may be able to join
- Patient younger then 18 going through surgery for twisted fallopian tubes
Who cannot join
- Girl above 18 and tubal torsion associated with ovary torsion
Trial locations and contacts
13 sites in 5 countries.
13 sites in 5 countries
Italy6 sites
ASP Trapani - presidio ospedaliero "S. Antonio Abate
Erice, 91016
Azienda Ospedaliera Universitaria di Padova
Padova, 35128
AOU Siena, Ospedale le Scotte
Siena, 53100
Ospedale infantile Regina Margherita
Torino, 10126
Institute for Maternal and Child Health - IRCCS "Burlo Garofolo
Trieste
Institute for Maternal and Child Health IRCCS G. Gaslini, Genova
Trieste
France4 sites
CHU Amiens
Amiens, 80000
Centre Hospitalier Universitaire de Angers
Angers, 49000
APHM, Hôpital La Timone Enfants et Hôpital Nord
Marseille
Hopital NECKER Enfant Malades
Paris
Turkey (Türkiye)1 site
Ege University Faculty of Medicine Children's Hospital
Izmir
About this study
Official title: Long Term Follow-up of Twisted Fallopian Tubes Among Young Girl. International Study
Isolated tubal torsion is a very rare event already in adults (1: 1.5 million women), it remains exceptional in children without being able to find a prevalence in the literature. The causes can be malformative or idiopathic, but even that remains unknown.
Because of the scarcity, surgical treatment is not standardized and left to the good care of the surgeon in charge.
- Conditions
- Twisted Fallopian Tube
- Being tested
- Surgery of twisted fallopian tubes
- Keywords
- Twisted Fallopian Tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery of twisted fallopian tubesProcedure or surgery
Patients diagnosed with twisted fallopian tube go through surgery.
| Study group | Role | What they receive |
|---|---|---|
| Twisted fallopian tubes cohort | Description of girls who went through surgery for twisted fallopian tubes Receives: Procedure: Surgery of twisted fallopian tubes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fallopian tube Surgery results
Evaluation of twisted fallopian surgery interest on then long terms, define as percentage of patients going through surgical revision
Measured: Evaluation 10 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study startApr 2021 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Twisted Fallopian TubeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813367
- Sponsor's protocol ID
- 69HCL21_0239
- Acronym
- Tubes
- Status last verified
- Mar 2021
- First submitted
- 22 Mar 2021
- Last updated
- 24 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow-up of Twisted Fallopian Tubes Among Young Girl. International Study
- ClinicalTrials.gov ID
- NCT04813367
- Acronym / sponsor ID
- Tubes / 69HCL21_0239
- Conditions
- Twisted Fallopian Tube
- Keywords
- Twisted Fallopian Tube
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 24 Mar 2021 (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.
Isolated tubal torsion is a very rare event already in adults (1: 1.5 million women), it remains exceptional in children without being able to find a prevalence in the literature. The causes can be malformative or idiopathic, but even that remains unknown.
Because of the scarcity, surgical treatment is not standardized and left to the good care of the surgeon in charge.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Twisted fallopian tubes cohort | – | Procedure: Surgery of twisted fallopian tubesDescription of girls who went through surgery for twisted fallopian tubes |
Who may qualify
- Ages
- Up to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Girl younger than 18 with isolated tubal torsion. Girl above 18 and tubal torsion associated with ovary torsion are excluded.
Key inclusion criteria (1 listed)
- Patient younger then 18 going through surgery for twisted fallopian tubes
Key exclusion criteria (1 listed)
- Girl above 18 and tubal torsion associated with ovary torsion
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 |
|---|---|---|
| Surgery of twisted fallopian tubesPatients diagnosed with twisted fallopian tube go through surgery. | Procedure or surgery | Twisted fallopian tubes cohort |
Primary outcome
Fallopian tube Surgery results
Time frame: Evaluation 10 years after surgery
Evaluation of twisted fallopian surgery interest on then long terms, define as percentage of patients going through surgical revision
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
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.
13 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Twisted Fallopian Tube, run by Hospices Civils de Lyon at 13 sites in 5 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 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: status not confirmed, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Italy, France, Lebanon, Romania, Turkey (Türkiye). 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 Daniel GORDUZA, Dr (4 72 35 52 27 ext. +33, Daniel.gorduza@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fallopian tube Surgery results (time frame: Evaluation 10 years after surgery). 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 24 Mar 2021.