Impact of Manual Lymphatic Drainage on Postoperative Edema of the Face and the Neck After Orthognathic Surgery.Open-label Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Assessment of edema using a centimeter scale.
研究概览
简要总结
Orthognathic surgery aims to standardize position of the maxilla and the mandible and therefore chewing, breathing, phonation and swallowing functions. In postoperative, several physical and functional consequences are observed in patients: transient edema of the face, maxillo-mandibular blocking (causing difficulties to eat and occasional weight loss), pain and sensory disturbances (labial or/and chin paresthesias).
Achieving sessions of manual lymphatic drainage by physiotherapist may allow faster decrease of postoperative edema, improved postoperative comfort and mental well-being.
The main objective of this study is to evaluate the efficacy of sessions of manual lymphatic drainage to reduce postoperative edema.
详细描述
Orthognathic surgery aims to standardize position of the maxilla and the mandible and therefore chewing, breathing, phonation and swallowing functions. In postoperative, several physical and functional consequences are observed in patients: transient edema of the face, maxillo-mandibular blocking (causing difficulties to eat and occasional weight loss), pain and sensory disturbances (labial or/and chin paresthesias).
Achieving sessions of manual lymphatic drainage by physiotherapist may allow faster decrease of postoperative edema, improved postoperative comfort and mental well-being.
The main objective of this study is to evaluate the efficacy of sessions of manual lymphatic drainage to reduce postoperative edema. Secondary objectives of the study are to assess impact of sessions of manual lymphatic drainage on patient comfort (pain, aesthetic discomfort, difficulty in breathing and discomfort in swallowing) and on ental well-being.
Patients allocated to the intervention group will have 13 sessions of manual lymphatic drainage and those allocated in control group will not.
Edema of patients will be measured at day 1, day 8, day 15 and day 22 after surgery by a different physiotherapist than physiotherapist achieving drainage sessions, blind to the randomization group of the patient. At the same time, comfort criteria will be assessed by a visual analogue scale and mental well-being with the General Health Questionnaire (GHQ28).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Orthognathic surgery (mandibular osteotomy, maxillary osteotomy or both)
- •Providing informed consent.
排除标准
- •Postoperative flexible restraint on the chin region.
- •Inability to understand and/or follow all scheduled visits.
研究组 & 干预措施
Manual Lymphatic Drainage
- 9 daily sessions of manual lymphatic drainage (except on Saturday/Sunday) starting at Day 1 after surgery.
- 4 more sessions (one every two days).
干预措施: Manual Lymphatic drainage (Other)
Control
No session of manual lymphatic drainage
结局指标
主要结局
Assessment of edema using a centimeter scale.
时间窗: day 22 after surgery
Assessment in centimeter of the distance between the ear lobes passing under the bottom of the columella, through the chin and passing under the bottom edge of the chin and assessment in centimeter of the neck circumference at 7.5 cm below the lobes ears.
次要结局
- mental well-being.(day 22)
- Comfort criteria(Day 22)