Nerve Coaptation in DIEP Flap Breast Reconstruction

Completed

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

• Registration Number: NCT03428789
• 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 DIEP flap breast reconstruction in Maastricht University Medical Center and returned for follow-up between September 2015 and July 2017. Semmes-Weinstein monofilaments were used for sensory testing of the breast. This study showed that nerve coaptation in DIEP flap breast reconstruction resulted in a significantly improved sensation of the reconstructed breast compared to non-innervated flaps.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Primary Completion: 2017-07-31
• Study Completion: 2017-07-31
• Status Verified: 2018-02
• Study First Submitted: 2018-02-05
• Study First Submitted QC: 2018-02-05
• Study First Posted: 2018-02-12
• Last Update Submitted: 2018-02-16
• Last Update Posted: 2018-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 81

Inclusion Criteria

• Female patients 18 years or older
• Unilateral or bilateral DIEP flap breast reconstruction
• Returned for follow-up between September 2015 and July 2017
• Informed consent

Exclusion Criteria

• Bilateral breast reconstruction with a unilateral innervated DIEP flap and a contralateral non-innervated flap
• Flaps that required a take-back

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Innervated DIEP flaps	Sensory nerve coaptation	Patients in this group underwent immediate or delayed, unilateral or bilateral deep inferior epigastric artery perforator (DIEP) flap breast reconstruction with additional sensory nerve coaptation.

Primary Outcome Measures

Name	Time	Method
The extent of sensory recovery of the reconstructed breast to touch	Through study completion up to 24 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