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临床试验/NCT03682159
NCT03682159已完成不适用

The Effect of Manual Lymphatic Drainage on Swelling After Orthognathic Surgery - a Qualitative and 3D Facial Analysis.

University Hospital, Ghent2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2016年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
2
主要终点
Change of swelling after orthognathic surgery assessed by 3D face scans

研究概览

简要总结

Introduction / background

Orthognathic surgery is an operation in which one or both jaws are fixed in a more favorable position performed by an osteotomy. In this way, large skeletal differences between the upper and lower jaw can be corrected surgically. The aim is to obtain a good and stable occlusion as well as to improve the facial aesthetics off the patient, where this would not be possible without surgery. These surgical procedures are accompanied by swelling of the face that can last for several days. The swelling is often considered unpleasant by the patients. The post-operative application of ice on the face can reduce the swelling. Also, performing manual lymphatic drainage (MLD) at the head and neck region would have a positive effect on the swelling after the operation. Manual lymphatic drainage is a kind of gentle massage performed by physiotherapists to reduce swelling in a faster way after surgery. This therapy is performed during the first days after the surgery and lasts about 30 minutes per session. There is still insufficient evidence to be whether or not this technique offers added value for patients undergoing jaw surgery.

Goal

The aim of this study is to investigate whether or not manual lymphatic drainage provides added value for patients undergoing jaw surgery. The facial swelling will be studied as the primary outcome variable. Other postoperative discomforts associated with orthognathic surgery are the secondary outcome variables. This study may or may not justify performing MLD and ensure that it is included in a postoperative protocol.

Methodological approach

The investigators would like to measure and compare the swelling in the face in an objective way between patients who received manual lymphatic drainage (intervention group) and patients who did not undergo manual lymphatic drainage (control group) The control group receives the standard postoperative care that is applied at the University Hospital Ghent. The intervention group also receives the same postoperative cares, as well as 5 MLD sessions during the first postoperative week (1st, 2nd, 3rd, 4th, 7th postoperative day).The objective measurement of the swelling can be done on the basis of a laser scan that can create 3D images of the face. For this, the patient should take a natural head position at rest and have a relaxed facial expression. This technique of imaging is non-invasive and there is no x-ray radiation involved! The 3D images are taken at the following times: 3 days, 1 week, 2 weeks, 1 month, 3 months and 6 months after the operation. Together with the scans, the patients were asked to fill in a questionnaire to frame the subjective postoperative discomfort associated with orthognathic surgery.

The change in swelling can be analyzed on the basis of specific measurements on the 3D images as well as by recording surface changes. The last 3D image is used as a reference to superimpose the other 3D images as there is no longer any swelling on this 3D image. After analyzing these data, it can be assessed to what extent manual lymphatic drainage offers an advantage to reduce swelling after orthognathic surgery.

详细描述

Subjects

The patients were collected from the maxillofacial department of the University Hospital of Ghent, Belgium between January 2015 and March 2018. The subjects had to meet certain inclusion criteria to participate in this study and they were rejected if one of the mentioned exclusion criteria was presented.

Inclusion criteria:

  1. Age 14 - 65 years
  2. ASA score I
  3. BSSO, LeFort I or Bimax

Exclusion criteria:

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
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
14 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 14 - 65 years
  • ASA score I
  • BSSO, LeFort I or Bimax

排除标准

  • Transgender patients
  • Other facial surgery's
  • Deviant medication
  • Cleft patients
  • Lot of facial hair
  • Refused to participate

研究组 & 干预措施

control

No Intervention

intervention

Experimental

干预措施: manual lymphatic drainage (Other)

结局指标

主要结局

Change of swelling after orthognathic surgery assessed by 3D face scans

时间窗: At the 3th, 7th and 14th day after surgery, as well as 1 month, 3 months and 6 months after surgery.

3D face scans were taken with the Planmeca Proface® (Planmeca Oy, Finland) at 6 fixed time points after surgery to measure change in facial swelling. This was done by superimposition of the different scans. Swelling was expressed in millimeters.

次要结局

  • Questionnaire with a five-point Likert-type Scale to measure perceived swelling(at the 3th, 7th and 14th day after surgery, as well as 1 month, 3 months and 6 months after surgery.)
  • Questionnaire with a 100 millimeter Visual Analogue Scale to measure perceived pain(At the 3th, 7th and 14th day after surgery, as well as 1 month, 3 months and 6 months after surgery.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tandheelkunde

Prof. Dr. Guy De Pauw

University Hospital, Ghent

研究点 (2)

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