The Effect of Manual Lymphatic Drainage on Swelling After Orthognathic Surgery - a Qualitative and 3D Facial Analysis.
Condition: Postoperative Care/Methods; Drainage/Methods; Edema/Prevention & Control; Orthognathic Surgical Procedures/Adverse Effects
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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:

        1. Transgender patients

        2. Other facial surgery's

        3. Deviant medication

        4. Cleft patients

        5. Lot of facial hair

        6. Refused to participate

      Next, patients who met all inclusion criteria and didn't drop out because of the exclusion
      criteria, were randomized in 2 treatment groups by block randomization. One group received
      the conventional postoperative cares from the University Hospital Ghent including topical ice
      application (also called cryotherapy), standardized medication and postoperative
      instructions. These patients were used as controls. The other group received the same
      conventional postoperative cares as mentioned in the control group, but also underwent 5
      sessions of MLD after the operation. Starting on the 1st postoperative day. These patients
      belonged to the intervention group.

      Protocol

      For every postoperative visit there was a fixed flowchart that needed to be followed. First
      the patient was asked to fill in the survey which questioned the pain and swelling. When this
      was done, a 3D face scan was taken of the untouched face in a natural resting position with a
      laser scanner (Planmeca Proface®, Planmeca Oy, Finland). Thereafter, only the intervention
      group received a MLD session if indicated by the protocol. Finally, the appointments for the
      future were checked in order to prevent no-shows. The last visit of every patient was planned
      6 months after surgery.

      Ethical approval

      The study was submitted to the research ethics board of the University Hospital of Ghent and
      a positive advise was given for this protocol. The study has also been registered (no.
      B670201629310). A written informed consent was obtained from each subject after the
      researcher explained the purpose and the procedure of the study containing the possible risks
      and benefits associated with the interventions.

      Manual Lymph drainage

      The MLD sessions were performed by 3 masters in physiotherapy (5th years) who were specially
      calibrated for this study by the same experienced MLD instructor and physiotherapist
      (V.V.B.). The used method for MLD was these described by Dr. Vodder and is a rather soft kind
      of massage that lasts for about 40 minutes per session. All MLD session were performed in a
      pleasant temperature and in an extremely relaxed atmosphere. In order to achieve this, it was
      requested not to talk during treatment. Also all patients were in a comfortable lying
      position when the MLD was performed.

      Questionnaire

      Before taking the face scans, a questionnaire was always filled out by the patient. These
      questionnaires were created with the aim to give an idea of the perceived swelling and pain.
      At the end, six questionnaires were collected per patient as prescribed by the protocol.

      Pain scores were assessed using a visual analogue scale (VAS) of 100 mm, representing all
      pain sensations from none to maximum. Zero mm indicates no pain, 50 mm moderate pain and 100
      mm worst pain possible. Patients were asked to place a mark along the line that corresponded
      to the amount of pain they were experiencing. In this questionnaire, two visual analogue
      scales were used to question the average pain of the last 24 hours and the worst pain of the
      last 24 hours.

      To measure the swelling in an subjective way, a five-point Likert-type scale was used. The
      patients were asked whether they suffered from swelling in the last 24 hours. Five possible
      answers could be checked: none, almost none, moderate, pretty much and very much.

      Face scan and processing

      Six face scans were taken from each patient with the Planmeca Proface® (Planmeca Oy, Finland)
      as indicated by the protocol. This technique of imaging is non-invasive and there is no x-ray
      radiation involved! The face scans were transformed into STL files and subsequently exported
      to software programs.
    

Intervention name(s): manual lymphatic drainage
Intervention type(s): Other
Intervention description(s): The intervention group received the same conventional postoperative cares as the control group, but also underwent 5 sessions of manual lymphatic drainage (MLD)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care