The Effect of Sensory Nerve Coaptation in DIEP Flap Breast Reconstruction on the Quality of Life: A Double-Blind Randomized Controlled Trial

Phase 2

Recruiting

Conditions: Insensate breast
numbed breast
10006295

Registration Number: NL-OMON52616

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 118

Inclusion Criteria

- Women of 18 years or older
- Diagnosed with breast cancer of carriership of gene mutations related with
breast cancer
- Undergoing unilateral or bilateral breast reconstruction via DIEP flap
- Immediate or delayed breast reconstruction

Exclusion Criteria

- Known (neurological) conditions that affect the sensation such as diabetes
mellitus or neuropathy (regardless of cause)
- Smoking
- BMI >35 kg/m2

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure will be quality of life, which will be evaluated<br /><br>using the BREAST-Q questionnaire (Reconstruction module). This is a validated<br /><br>questionnaire that is specifically designed for breast cancer patiënts<br /><br>undergoing breast reconstruction. Participants will be asked to complete the<br /><br>questionnaires pre-operatively and at 6, 12 and 24 months follow-up (optionally<br /><br>additional follow-up at 36 and 60 months). The score of the BREAST-Q will be<br /><br>evaluated using the Q-score program. The higher the BREAST-Q score, the higher<br /><br>the patient reported quality of life.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcome will be sensation of the breast. Sensation will be tested<br /><br>using Semmes-Weinstein monofilaments (SWM), Pressure-Specified Sensory Device<br /><br>(PSSD) and/or Quantitative Sensory Testing (QST). Examinations will be<br /><br>performed at inclusion, 3, 6, 12, 18 and 24 months follow-up (optionally<br /><br>additional follow-up at 36 and 60 months). </p><br>