Twisted Fallopian Tubes | NCT04813367

Studies
Twisted Fallopian Tubes

NCT04813367

Sponsor

Hospices Civils de Lyon

Status

Unknown status

Last Update Posted

Mar 24, 2021Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Twisted Fallopian Tube

Interventions

Surgery of twisted fallopian tubes

Countries

France
Italy
Lebanon
Romania
Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2021Estimated

Primary Completion Date

Apr 2021Estimated

Completion Date

Oct 2021Estimated

First Submitted Date

Mar 22, 2021

First Submission Date that Met QC Criteria

Mar 22, 2021

First Posted Date

Mar 24, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 22, 2021

Last Update Posted Date

Mar 24, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Twisted fallopian tubes cohort		Description of girls who went through surgery for twisted fallopian tubes	Procedure: Surgery of twisted fallopian tubes

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgery of twisted fallopian tubes	Procedure	Patients diagnosed with twisted fallopian tube go through surgery.	Twisted fallopian tubes cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Girl younger than 18 with isolated tubal torsion. Girl above 18 and tubal torsion associated with ovary torsion are excluded.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Daniel GORDUZA, Dr	Contact	4 72 35 52 27	+33	Daniel.gorduza@chu-lyon.fr
Julien BERTHILLER, Dr	Contact	4 27 85 63 01	+33	julien.berthiller@chu-lyon.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Amiens		Amiens		80000	France
Centre Hospitalier Universitaire de Angers