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

NCT03682159 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2019-02-04

No results posted yet for this study

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.

Conditions

  • Postoperative Care/Methods
  • Drainage/Methods
  • Edema/Prevention & Control
  • Orthognathic Surgical Procedures/Adverse Effects

Interventions

OTHER

manual lymphatic drainage

The intervention group received the same conventional postoperative cares as the control group, but also underwent 5 sessions of manual lymphatic drainage (MLD)

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Guy De Pauw, Prof. Dr. · University Ghent

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-04-30
Completion
2018-09-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03682159 on ClinicalTrials.gov