Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nerve Coaptation in LTP Flap Breast Reconstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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
Breast Cancer Procedure: Sensory nerve coaptation

Layout table for study information
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 : February 2016
Actual Primary Completion Date : April 2019
Actual Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


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.
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.



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female patients of 18 years or older.
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959943


Locations
Layout table for location information
Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6229 HX
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Layout table for investigator information
Principal Investigator: René van der Hulst, MD, PhD Maastricht University Medical Center

Layout table for additonal information
Responsible Party: Rene van der Hulst, Head of the Plastic Surgery department, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT03959943     History of Changes
Other Study ID Numbers: METC16-4-147
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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, Maastricht University Medical Center:
Breast reconstruction
LTP flap
Sensory recovery
Breast sensation
Nerve coaptation