Sensory Recovery of the Breast Following Innervated and Non-innervated DIEP Flap Breast Reconstructions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 81
- Locations
- 1
- Primary Endpoint
- The extent of sensory recovery of the reconstructed breast to touch
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
The extent of sensory recovery of the reconstructed breast to touch
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Rene van der Hulst
Prof. Dr.
Maastricht University Medical Center