Nerve Coaptation Improves the Sensory Recovery of the Breast in DIEP Flap Breast Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Mean monofilament value as a measure for the sensory recovery of the reconstructed breast
研究概览
简要总结
Restoring the sensation of the breast becomes increasingly recognized as a critical part of autologous breast reconstruction. A prospective study was conducted of all patients who underwent either innervated or non-innervated deep inferior epigastric perforator (DIEP) flap breast reconstruction in Maastricht University Medical Center between August 2016 and August 2018 and who returned between for a follow-up visit between the start of the study and August 2019. Semmes-Weinstein monofilaments were used for sensory testing of the breast.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients 18 years or older
- •Unilateral or bilateral DIEP flap breast reconstruction
- •Returned for follow-up between August 2016 and August 2019
- •Informed consent
排除标准
- •Total flap loss complication
- •Flaps that required a take-back
- •Follow-up less than six months postoperatively
- •Only one postoperative measurement at less than 12 months follow-up
- •Mixed reconstructions: an innervated breast reconstruction on one side and a noninnervated breast reconstruction on the other side
结局指标
主要结局
Mean monofilament value as a measure for the sensory recovery of the reconstructed breast
时间窗: Through study completion up to 36 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.
次要结局
- Mean monofilament value as a measure for the sensory recovery of the reconstructed breast(Through study completion up to 36 months postoperatively)
研究者
Rene van der Hulst
Head of the Plastic Surgery department
Maastricht University Medical Center