Nerve Coaptation in LTP Flap Breast Reconstruction

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: Sensory nerve coaptation

• Registration Number: NCT03959943
• Lead Sponsor: Maastricht University Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Primary Completion: 2019-04
• Study Completion: 2019-04
• Study First Submitted: 2019-05-20
• Study First Submitted QC: 2019-05-21
• Study First Posted: 2019-05-22
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-19
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Innervated LTP flaps	Sensory nerve coaptation	Patients in this group underwent immediate or delayed, unilateral or bilateral lateral thigh perforator (LTP) flap breast reconstruction with additional sensory nerve coaptation.

Primary Outcome Measures

Name	Time	Method
The sensory recovery of the reconstructed breast as assessed by Semmes-Weinstein monofilaments	Through study completion up to 27 months postoperatively	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.

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands