Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Twisted Fallopian Tubes (Tubes)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04813367
Recruitment Status : Not yet recruiting
First Posted : March 24, 2021
Last Update Posted : March 24, 2021
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.


Condition or disease Intervention/treatment
Twisted Fallopian Tube Procedure: Surgery of twisted fallopian tubes

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Long Term Follow-up of Twisted Fallopian Tubes Among Young Girl. International Study
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : October 2021
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Twisted fallopian tubes cohort
Description of girls who went through surgery for twisted fallopian tubes
 Procedure: Surgery of twisted fallopian tubes
Patients diagnosed with twisted fallopian tube go through surgery.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Girl younger than 18 with isolated tubal torsion. Girl above 18 and tubal torsion associated with ovary torsion are excluded.
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04813367


Contacts
Layout table for location contacts
Contact: Daniel GORDUZA, Dr 4 72 35 52 27 ext +33 Daniel.gorduza@chu-lyon.fr
Contact: Julien BERTHILLER, Dr 4 27 85 63 01 ext +33 julien.berthiller@chu-lyon.fr

Locations
Layout table for location information
France
CHU Amiens
Amiens, France, 80000
Centre Hospitalier Universitaire de Angers
Angers, France, 49000
APHM, Hôpital La Timone Enfants et Hôpital Nord
Marseille, France
Hopital NECKER Enfant Malades
Paris, France
Italy
ASP Trapani - presidio ospedaliero "S. Antonio Abate
Erice, Italy, 91016
Azienda Ospedaliera Universitaria di Padova
Padova, Italy, 35128
AOU Siena, Ospedale le Scotte
Siena, Italy, 53100
Ospedale infantile Regina Margherita
Torino, Italy, 10126
Institute for Maternal and Child Health - IRCCS "Burlo Garofolo
Trieste, Italy
Institute for Maternal and Child Health IRCCS G. Gaslini, Genova
Trieste, Italy
Lebanon
Hôtel-Dieu de France Hospital
Beirut, Lebanon
Romania
Hospital d Urgences pour les enfants
Iaşi, Romania
Turkey
Ege University Faculty of Medicine Children's Hospital
İzmir, Turkey
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04813367    
Other Study ID Numbers: 69HCL21_0239
First Posted: March 24, 2021    Key Record Dates
Last Update Posted: March 24, 2021
Last Verified: March 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Twisted Fallopian Tube