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

• Sponsor: Centre Hospitalier Universitaire de Besancon (Other)
• Overall Status: Completed
• CT.gov ID: NCT06101732
• Collaborator: (none)
• Enrollment: 140
• Location: 1
• Actual Duration (Months): 5.3
• Patients Per Site Per Month: 26.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Surgery

Study Design

• Study Type: Observational
• Actual Enrollment: 140 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Breast Reconstruction by Lipomodeling Alone or With Flap: Evaluation in Franche-Comté
• Actual Study Start Date: May 5, 2022
• Actual Primary Completion Date: Oct 13, 2022
• Actual Study Completion Date: Oct 13, 2022

Outcome Measures

Primary Outcome Measures

1. 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

1. description of patients' age [at inclusion]

   patient age

2. description of patients' Body Mass Index [at inclusion]

   Body Mass Index

3. description of patients' menopause status [at the time of data collection]

   menopause status

4. description of patients' smoking status [at inclusion]

   smoking status

5. description of patients' diabetes or other medical condition [at inclusion]

6. description of patients' relevant medical history [at inclusion]

   relevant medical history

7. description of patients' History of breast surgery [at inclusion]

   hsitory of breast surgery

8. description of patients' type of cancer [at inclusion]

   cancer histology

9. description of patients' type of surgical treatment [at inclusion]

   type of breast reconstruction using lipomodelling alone or in combination with a flap

10. description of patients' Type of treatment associated with surgery [at inclusion]

    Type of treatment associated with surgery

11. description of Time elapsed between mastectomy and reconstruction [at inclusion]

    number of month between the date of mastectomy and date of reconstruction

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de besancon	Besançon		France	25030

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Besancon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Besancon
• ClinicalTrials.gov Identifier: NCT06101732
• Other Study ID Numbers: 2022/684
• First Posted: Oct 26, 2023
• Last Update Posted: Oct 27, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centre Hospitalier Universitaire de Besancon: lipodelling; breast reconstruction

Study Results

No Results Posted as of Oct 27, 2023