NCT03428789

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 12, 2018

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

1.9 years

First QC Date

February 5, 2018

Last Update Submit

February 16, 2018

Conditions

Breast Cancer

Keywords

breast reconstructionDIEP flapNerve coaptationSensory recovery

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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.

Procedure: Sensory nerve coaptation

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.

Interventions

Sensory nerve coaptationPROCEDURE

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.

Also known as: Neurotization, Neurorrhaphy, Reinnervation
Innervated DIEP flaps

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale patients of 18 years or older.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

In this prospective study, patients who underwent an innervated or non-innervated DIEP flap breast reconstruction between January 2010 and July 2016 at Maastricht University Medical Center in the Netherlands were included if they returned for follow-up between September 2015 and July 2017.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229 HX, Netherlands

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Nerve Transfer

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Neurosurgical ProceduresSurgical Procedures, Operative

Study Officials

  • René van der Hulst, MD, PhD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

February 5, 2018

First Posted

February 12, 2018

Study Start

September 1, 2015

Primary Completion

July 31, 2017

Study Completion

July 31, 2017

Last Updated

February 19, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)