Congenital Naevi of Lower Limb in the Child (NAEVUS)

Congenital Nevi in the Lower Limb in Children : Which Size Can be Afforded by a Simple Surgical Procedure ?

Depending on its dimensions, it is difficult to predict if a congenital nevi of the lower limb can be surgically removed by a unique simple procedure or by a complex procedure (expander, skin graft etc..), with a good result.

This study retrospectively reviewed the practice of our team of surgeons depending on the size of the naevus to reveal a dimension threshold that can be used in the future to help to choose between a simple or a complex procedure.

Study Overview

• Status: Completed
• Conditions: Congenital Melanocytar Nevi in the Lower Limb

Detailed Description

Retrospective study using medical file data only. No intervention nor phone call etc.. to the patients or their parents.

• Study Type: Observational
• Enrollment (Actual): 176

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children that had congenital nevi surgery removal, in the lower limb.

Description

Inclusion criteria:

- Child + congenital nevi in the lower limb + had removal surgery

Exclusion criteria:

- More than one congenital nevi in the lower limb.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nevi Estimated Size	Nevi Estimated Size (centimeters)	within three weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post-operative complications depending on the initial size of the naevus	post-operative complications depending on the initial size of the naevus : percentage of complication rate	assessed within 6 months after surgery

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 1984
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: March 3, 2020
• First Submitted That Met QC Criteria: March 3, 2020
• First Posted (Actual): March 5, 2020

Study Record Updates

• Last Update Posted (Actual): June 5, 2020
• Last Update Submitted That Met QC Criteria: June 4, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: congenital nevi; naevus; Congenital skin neoplasm; Reconstructive surgical procedures
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Nevi and Melanomas; Nevus
• Other Study ID Numbers: RECHMPL20_0063

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No