- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07596862
Remote Assesment of Functional Sequelae in Patients Operated for Congenital Syndactyly (DISTSSEQUELO)
May 18, 2026 updated by: University Hospital, Lille
Evaluation of the Gilbert Dorsal Commissural Flap in the Managment of Congenital Syndactylies
The aim of th study is to evaluate patients who have been operated for congenital syndactylies.
The surgical technique has evolved, and the donnor site for the total skin graft is not the same than 10 years ago.
Furthermore, the investigators want to evaluate the function of the hand and the evolution of the operated web space.
The patient is examined in consultation by the same doctor, the investigator list complications and evolution of the hand.
the investigators also ask the patient and his parents about the satisfaction of the surgery.
Study Overview
Study Type
Observational
Enrollment (Actual)
37
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Lille, France
- CHU de LILLE
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Il s'agit d'une cohorte de patients opérés d'une syndactylie congénitale des doigts longs.
On étudie ici la rétraction commissurale et les séquelles fonctionnelles et esthétiques, avec greffe de peau totale prélevée au niveau du pli du poignet.
Description
Inclusion Criteria:
- operated between 2005 and 2019 at Lille University Hospital.
- born between 2003 and 2020.
- With congenital syndactyly (ies) of the upper limb.
- Syndromic or non syndromic congenital syndactyly of the upper of the long fingers.
Exclusion Criteria:
Patients operated on before 2005 or after 2020
- Acquired syndactyly (post-traumatic)
- Syndactyly (ies) of the lower limb.
- congenital syndactyly of the first webspace
- Impossible to obtain consent from parents or patients or refusal
- Unable to travel to Lille University Hospital for the consultation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Consultation
Patients will be called in for consultation in the CHU de Lille to be examined.
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Patients will be called in for consultation in the CHU de Lille to be examined.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Study of the retraction of the webspace with Withey scale
Time Frame: From 4 years to 18 years after the surgery
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From 4 years to 18 years after the surgery
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Evaluation of the scars with Vancouver scale.
Time Frame: From 4 years to 18 years after the surgery
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From 4 years to 18 years after the surgery
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Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Evaluation of the scar from the donor site of the total skin graft with Vancouver scale.
Time Frame: 4 years to 18 years after the surgery
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4 years to 18 years after the surgery
|
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Study of the flessum with a goniometer.
Time Frame: 4 years to 18 years after the surgery
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4 years to 18 years after the surgery
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Study of the clinodactyly with a goniometer.
Time Frame: 4 years to 18 years after the surgery
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4 years to 18 years after the surgery
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Study of the patients and parents satisfaction with a Likert scale.
Time Frame: 4 years to 18 years after the surgery
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4 years to 18 years after the surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 7, 2023
Primary Completion (Actual)
December 1, 2024
Study Completion (Actual)
June 30, 2025
Study Registration Dates
First Submitted
November 13, 2023
First Submitted That Met QC Criteria
May 18, 2026
First Posted (Actual)
May 19, 2026
Study Record Updates
Last Update Posted (Actual)
May 19, 2026
Last Update Submitted That Met QC Criteria
May 18, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Bone Diseases
- Musculoskeletal Diseases
- Musculoskeletal Abnormalities
- Congenital Abnormalities
- Bone Diseases, Developmental
- Limb Deformities, Congenital
- Synostosis
- Dysostoses
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Hand Deformities
- Upper Extremity Deformities, Congenital
- Syndactyly
- Hand Deformities, Congenital
- Professional Practice
- Organization and Administration
- Health Services Administration
- Referral and Consultation
Other Study ID Numbers
- 2020_88
- 2021-A02023-38 (Other Identifier: ID-RCB number, ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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