Sensory Nerve Coaptation in DIEP Flap Breast Reconstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

126 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-01

Study Completion Date

2019-09-01

Brief Summary

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Restoring the sensation of the breast becomes increasingly recognized as a critical part of autologous breast reconstruction. A prospective study was conducted of all patients who underwent either innervated or non-innervated deep inferior epigastric perforator (DIEP) flap breast reconstruction in Maastricht University Medical Center between August 2016 and August 2018 and who returned between for a follow-up visit between the start of the study and August 2019. Semmes-Weinstein monofilaments were used for sensory testing of the breast.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Innervated DIEP flaps

Patients in this group underwent immediate or delayed, unilateral or bilateral DIEP flap breast reconstruction with additional sensory nerve coaptation.

Sensory nerve coaptation

Intervention Type PROCEDURE

A recipient sensory nerve branch of the 11th-12th intercostal nerve 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.

Noninnervated DIEP flaps

Patients in this group underwent immediate or delayed, unilateral or bilateral DIEP flap breast reconstruction without sensory nerve coaptation.

No interventions assigned to this group

Interventions

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Sensory nerve coaptation

A recipient sensory nerve branch of the 11th-12th intercostal nerve 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.

Intervention Type PROCEDURE

Other Intervention Names

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Neurotization Reinnervation Neurorrhaphy

Eligibility Criteria

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Inclusion Criteria

* Female patients 18 years or older
* Unilateral or bilateral DIEP flap breast reconstruction
* Returned for follow-up between August 2016 and August 2019
* Informed consent

Exclusion Criteria

* Total flap loss complication
* Flaps that required a take-back
* Follow-up less than six months postoperatively
* Only one postoperative measurement at less than 12 months follow-up
* Mixed reconstructions: an innervated breast reconstruction on one side and a noninnervated breast reconstruction on the other side

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No