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Nerve Coaptation in LTP Flap Breast Reconstruction

Sponsor
Maastricht University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03959943
Collaborator
(none)
46
Enrollment
1
Location
37.9
Actual Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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 lateral thigh perforator (LTP) flap breast reconstruction in Maastricht University Medical Center and returned for follow-up between February 2016 and April 2019. Semmes-Weinstein monofilaments were used for sensory testing of the breast.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Sensory nerve coaptation

Study Design

Study Type:
Observational
Actual Enrollment :
46 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Sensory Recovery of the Breast Following Innervated and Non-innervated Lateral Thigh Perforator (LTP) Flap Breast Reconstructions
Actual Study Start Date :
Feb 1, 2016
Actual Primary Completion Date :
Apr 1, 2019
Actual Study Completion Date :
Apr 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Innervated LTP flaps

Patients in this group underwent immediate or delayed, unilateral or bilateral lateral thigh perforator (LTP) flap breast reconstruction with additional sensory nerve coaptation.

Procedure: Sensory nerve coaptation
A recipient sensory nerve branch of the lateral cutaneous femoral nerve (LCFN) 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.
Other Names:
  • Neurotization
  • Reinnervation

    		•
    Non-innervated LTP flaps

    Patients in this group underwent immediate or delayed, unilateral or bilateral lateral thigh perforator (LTP) flap breast reconstruction without sensory nerve coaptation.

    Outcome Measures

    Primary Outcome Measures

    1. The sensory recovery of the reconstructed breast as assessed by Semmes-Weinstein monofilaments [Through study completion up to 27 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Inclusion Criteria:

    • Female patients 18 years or older

    • Unilateral or bilateral LTP flap breast reconstruction

    • Returned for follow-up between February 2016 and April 2019

    • Informed consent

    Exclusion Criteria:

    • In case of a total flap loss

    • Flaps that required a take-back

    • Follow-up less than six months postoperatively

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Maastricht University Medical Center Maastricht Limburg Netherlands 6229 HX

    Sponsors and Collaborators

    • Maastricht University Medical Center

    Investigators

    • Principal Investigator: RenĂ© van der Hulst, MD, PhD, Maastricht University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rene van der Hulst, Head of the Plastic Surgery department, Maastricht University Medical Center
    ClinicalTrials.gov Identifier:
    NCT03959943
    Other Study ID Numbers:
    • METC16-4-147
    First Posted:
    May 22, 2019
    Last Update Posted:
    May 22, 2019
    Last Verified:
    May 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Rene van der Hulst, Head of the Plastic Surgery department, Maastricht University Medical Center
    Breast reconstruction
    LTP flap
    Sensory recovery
    Breast sensation
    Nerve coaptation

    Study Results

    No Results Posted as of May 22, 2019