LIMBO : Breast Reconstruction by Lipomodeling Alone or With Flap: Evaluation in Franche-Comté

Completed

• Conditions: Breast Cancer; Surgery

• Registration Number: NCT06101732
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

The Limbo study is a retrospective descriptive study which aims to establish the current state of breast reconstruction surgery at the Besançon University Hospital and Hôpital Nord Franche-Comté, between October 2017 and December 2021.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-05
• Primary Completion: 2022-10-13
• Study Completion: 2022-10-13
• Status Verified: 2023-01
• Study First Submitted: 2023-10-17
• Study First Submitted QC: 2023-10-20
• Last Update Submitted: 2023-10-25
• Study First Posted: 2023-10-26
• Last Update Posted: 2023-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

Inclusion Criteria

• Patient who has undergone breast reconstruction using lipomodelling alone or in association with a flap (greater dorsal, DIEP Deep Inferior Epigastric Perforator flap or TRAM Tranverse Rectus Abdominis Myocutaneous Flap), since October 2017.

Patient whose follow-up in plastic surgery is considered completed (final result obtained, patient lost to follow-up or not wishing to continue) at the time of data collection.

Exclusion Criteria

• Patient under 18 at first consultation
• Opposition of the patient to the collection of her data

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
number of surgical procedures according to the type of breast reconstruction using lipomodelling alone or in combination with a flap	Between october 2017 and 2022	number of surgical procedures

Secondary Outcome Measures

Name	Time	Method
description of patients' menopause status	at the time of data collection	menopause status
description of patients' age	at inclusion	patient age
description of patients' Body Mass Index	at inclusion	Body Mass Index
description of patients' smoking status	at inclusion	smoking status
description of patients' type of cancer	at inclusion	cancer histology
description of patients' relevant medical history	at inclusion	relevant medical history
description of patients' diabetes or other medical condition	at inclusion
description of patients' type of surgical treatment	at inclusion	type of breast reconstruction using lipomodelling alone or in combination with a flap
description of patients' Type of treatment associated with surgery	at inclusion	Type of treatment associated with surgery
description of patients' History of breast surgery	at inclusion	hsitory of breast surgery
description of Time elapsed between mastectomy and reconstruction	at inclusion	number of month between the date of mastectomy and date of reconstruction

Trial Locations

Locations (1)

CHU de besancon; 🇫🇷 Besançon, France