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

Breast Cancer Clinical Trial

— LIMBO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06101732
• Other study ID #: 2022/684
• Status: Completed
• Start date: May 5, 2022
• Est. completion date: October 13, 2022

Study information

• Verified date: January 2023
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: October 13, 2022
• Est. primary completion date: October 13, 2022
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Surgery

Locations

Country	Name	City	State
France	CHU de besancon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of surgical procedures according to the type of breast reconstruction using lipomodelling alone or in combination with a flap	number of surgical procedures	Between october 2017 and 2022
Secondary	description of patients' age	patient age	at inclusion
Secondary	description of patients' Body Mass Index	Body Mass Index	at inclusion
Secondary	description of patients' menopause status	menopause status	at the time of data collection
Secondary	description of patients' smoking status	smoking status	at inclusion
Secondary	description of patients' diabetes or other medical condition		at inclusion
Secondary	description of patients' relevant medical history	relevant medical history	at inclusion
Secondary	description of patients' History of breast surgery	hsitory of breast surgery	at inclusion
Secondary	description of patients' type of cancer	cancer histology	at inclusion
Secondary	description of patients' type of surgical treatment	type of breast reconstruction using lipomodelling alone or in combination with a flap	at inclusion
Secondary	description of patients' Type of treatment associated with surgery	Type of treatment associated with surgery	at inclusion
Secondary	description of Time elapsed between mastectomy and reconstruction	number of month between the date of mastectomy and date of reconstruction	at inclusion