Nerve Coaptation in LTP Flap Breast Reconstruction

Breast Cancer Clinical Trial

Official title:

Sensory Recovery of the Breast Following Innervated and Non-innervated Lateral Thigh Perforator (LTP) Flap Breast Reconstructions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03959943
• Other study ID #: METC16-4-147
• Status: Completed
• Start date: February 2016
• Est. completion date: April 2019

Study information

• Verified date: October 2023
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The sensory recovery of the breast remains an undervalued aspect of breast reconstruction and surgical reinnervation is not regarded as a priority by most reconstructive surgeons. A prospective study was conducted of all patients who underwent either innervated or non-innervated lateral thigh perforator (LTP) flap breast reconstruction in Maastricht University Medical Center and returned for follow-up between February 2016 and April 2019. Semmes-Weinstein monofilaments were used for sensory testing of the breast.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Female patients 18 years or older

• Unilateral or bilateral LTP flap breast reconstruction

• Returned for follow-up between February 2016 and April 2019

• Informed consent

Exclusion Criteria:

• In case of a total flap loss

• Flaps that required a take-back

• Follow-up less than six months postoperatively

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• Sensory nerve coaptation
A recipient sensory nerve branch of the lateral cutaneous femoral nerve (LCFN) was reattached to a donor nerve in the chest area. The anterior cutaneous branch of the second or third intercostal nerve was used as the donor nerve. Direct, end-to-end nerve coaptation was performed.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The sensory recovery of the reconstructed breast as assessed by Semmes-Weinstein monofilaments	The sensory recovery of the breast to touch was tested at different follow-up moments after the initial surgery. Semmes-Weinstein monofilaments were used for sensory testing. Nine areas of the breast, indicating native skin and flap skin, were tested. Mean monofilament values were calculated for each area and compared between groups.	Through study completion up to 27 months postoperatively