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Nerve Coaptation in LTP Flap Breast Reconstruction

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ClinicalTrials.gov Identifier: NCT03959943
Recruitment Status : Completed
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Rene van der Hulst, Maastricht University Medical Center

Tracking Information
First Submitted Date May 20, 2019
First Posted Date May 22, 2019
Last Update Posted Date May 22, 2019
Actual Study Start Date February 2016
Actual Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 21, 2019)
The sensory recovery of the reconstructed breast as assessed by Semmes-Weinstein monofilaments [ Time Frame: 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Nerve Coaptation in LTP Flap Breast Reconstruction
Official Title Sensory Recovery of the Breast Following Innervated and Non-innervated Lateral Thigh Perforator (LTP) Flap Breast Reconstructions
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population In this prospective study, patients who underwent an innervated or non-innervated LTP flap breast reconstruction between December 2014 and August 2018 at Maastricht University Medical Center in the Netherlands were included if they returned for follow-up between February 2016 and April 2019.
Condition Breast Cancer
Intervention 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
Study Groups/Cohorts
  • 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.
    Intervention: Procedure: Sensory nerve coaptation
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 21, 2019)
46
Original Actual Enrollment Same as current
Actual Study Completion Date April 2019
Actual Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Female patients of 18 years or older.
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT03959943
Other Study ID Numbers METC16-4-147
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Rene van der Hulst, Maastricht University Medical Center
Study Sponsor Maastricht University Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: René van der Hulst, MD, PhD Maastricht University Medical Center
PRS Account Maastricht University Medical Center
Verification Date May 2019