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

NCT03682159 | Completed DMC

• 1 other identifier: B670201629310
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Secondary Outcomes (2)

• 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.

• 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.

Study Arms (2)

control

NO INTERVENTION

intervention

EXPERIMENTAL

Other: manual lymphatic drainage

Interventions

manual lymphatic drainage OTHER

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

intervention

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University of Ghent

Ghent, 9000, Belgium

Location

Related Publications (2)

• Yaedu RYF, Mello MAB, Tucunduva RA, da Silveira JSZ, Takahashi MPMS, Valente ACB. Postoperative Orthognathic Surgery Edema Assessment With and Without Manual Lymphatic Drainage. J Craniofac Surg. 2017 Oct;28(7):1816-1820. doi: 10.1097/SCS.0000000000003850.

  PMID: 28872503 BACKGROUND

• Szolnoky G, Szendi-Horvath K, Seres L, Boda K, Kemeny L. Manual lymph drainage efficiently reduces postoperative facial swelling and discomfort after removal of impacted third molars. Lymphology. 2007 Sep;40(3):138-42.

  PMID: 18062616 BACKGROUND

MeSH Terms

Conditions

Edema

Interventions

Manual Lymphatic Drainage

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Drainage; Physical Therapy Modalities; Rehabilitation

Study Officials

• Guy De Pauw, Prof. Dr.

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Guy De Pauw

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: September 24, 2018
• Study Start: September 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: September 1, 2018
• Last Updated: February 4, 2019

Record last verified: 2019-01

Locations

BE (1)