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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04813367
Other study ID # 69HCL21_0239
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 2021
Est. completion date October 2021

Study information

Verified date March 2021
Source Hospices Civils de Lyon
Contact Daniel GORDUZA, Dr
Phone 4 72 35 52 27
Email Daniel.gorduza@chu-lyon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. Because of the scarcity, surgical treatment is not standardized and left to the good care of the surgeon in charge.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date October 2021
Est. primary completion date April 2021
Accepts healthy volunteers No
Gender Female
Age group N/A to 18 Years
Eligibility Inclusion Criteria: - Patient younger then 18 going through surgery for twisted fallopian tubes Exclusion Criteria: - Girl above 18 and tubal torsion associated with ovary torsion

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Surgery of twisted fallopian tubes
Patients diagnosed with twisted fallopian tube go through surgery.

Locations

Country Name City State
France CHU Amiens Amiens
France Centre Hospitalier Universitaire de Angers Angers
France APHM, Hôpital La Timone Enfants et Hôpital Nord Marseille
France Hopital NECKER Enfant Malades Paris
Italy ASP Trapani - presidio ospedaliero "S. Antonio Abate Erice
Italy Azienda Ospedaliera Universitaria di Padova Padova
Italy AOU Siena, Ospedale le Scotte Siena
Italy Ospedale infantile Regina Margherita Torino
Italy Institute for Maternal and Child Health - IRCCS "Burlo Garofolo Trieste
Italy Institute for Maternal and Child Health IRCCS G. Gaslini, Genova Trieste
Lebanon Hôtel-Dieu de France Hospital Beirut
Romania Hospital d Urgences pour les enfants Iasi
Turkey Ege University Faculty of Medicine Children's Hospital Izmir

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Countries where clinical trial is conducted

France,  Italy,  Lebanon,  Romania,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fallopian tube Surgery results Evaluation of twisted fallopian surgery interest on then long terms, define as percentage of patients going through surgical revision Evaluation 10 years after surgery