NCT06101732

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 17, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
Last Updated

October 27, 2023

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

October 17, 2023

Last Update Submit

October 25, 2023

Conditions

Breast CancerSurgery

Keywords

lipodellingbreast reconstruction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • description of patients' age

    at inclusion

  • description of patients' Body Mass Index

    at inclusion

  • description of patients' menopause status

    at the time of data collection

  • description of patients' smoking status

    at inclusion

  • description of patients' diabetes or other medical condition

    at inclusion

  • +6 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de besancon

Besançon, 25030, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2023

First Posted

October 26, 2023

Study Start

May 5, 2022

Primary Completion

October 13, 2022

Study Completion

October 13, 2022

Last Updated

October 27, 2023

Record last verified: 2023-01

Locations

FR(1)