Nerve Coaptation in DIEP Flap Breast Reconstruction

NCT ID: NCT03428789

Last Updated: 2018-02-19

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

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-07-31

Brief Summary

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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

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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 deep inferior epigastric artery perforator (DIEP) flap breast reconstruction with additional sensory nerve coaptation.

Sensory nerve coaptation

Intervention Type PROCEDURE

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.

Non-innervated DIEP flaps

Patients in this group underwent immediate or delayed, unilateral or bilateral deep inferior epigastric artery perforator (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 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.

Intervention Type PROCEDURE

Other Intervention Names

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Neurotization Neurorrhaphy Reinnervation

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 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Rene van der Hulst

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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René van der Hulst, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

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Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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METC 16-4-147

Identifier Type: -

Identifier Source: org_study_id

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