- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03959943
Nerve Coaptation in LTP Flap Breast Reconstruction
October 19, 2023 updated by: Rene van der Hulst, Maastricht University Medical Center
Sensory Recovery of the Breast Following Innervated and Non-innervated Lateral Thigh Perforator (LTP) Flap Breast Reconstructions
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
46
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Limburg
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Maastricht, Limburg, Netherlands, 6229 HX
- Maastricht University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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.
|
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:
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Through study completion up to 27 months postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: René van der Hulst, MD, PhD, Maastricht University Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2016
Primary Completion (Actual)
April 1, 2019
Study Completion (Actual)
April 1, 2019
Study Registration Dates
First Submitted
May 20, 2019
First Submitted That Met QC Criteria
May 21, 2019
First Posted (Actual)
May 22, 2019
Study Record Updates
Last Update Posted (Actual)
October 23, 2023
Last Update Submitted That Met QC Criteria
October 19, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- METC16-4-147
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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