Nerve Coaptation in DIEP Flap Breast Reconstruction

Breast Cancer Clinical Trial

Official title:

Sensory Recovery of the Breast Following Innervated and Non-innervated DIEP Flap Breast Reconstructions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03428789
• Other study ID #: METC 16-4-147
• Status: Completed
• Phase: N/A
• First received: February 5, 2018
• Last updated: February 16, 2018
• Start date: September 2015
• Est. completion date: July 31, 2017

Study information

• Verified date: February 2018
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: July 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• Sensory nerve coaptation
A recipient sensory nerve of the abdomen was reattached to a donor nerve in the chest area. The sensory branch of usually the 11th intercostal nerve was used as recipient nerve for nerve coaptation and the anterior cutaneous branch of the third intercostal nerve was used as donor nerve. Direct, end-to-end nerve coaptation was performed with two stitches.

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 extent of sensory recovery of the reconstructed breast to touch	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 24 months postoperatively