Postoperative Care/MethodsNCT03682159
The Effect of Manual Lymphatic Drainage on Swelling After Orthognathic Surgery - a Qualitative and 3D Facial Analysis.
A study testing manual lymphatic drainage in people with Postoperative Care/Methods and Drainage/Methods, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Postoperative Care/Methods, Drainage/Methods, Edema/Prevention & Control
- What is being tested?
- manual lymphatic drainage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2016to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 14 - 65 years
- ASA score I
- BSSO, LeFort I or Bimax
Who cannot join
- Transgender patients
- Other facial surgery's
- Deviant medication
- Cleft patients
- Lot of facial hair
- Refused to participate
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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:
- Age 14 - 65 years
- ASA score I
- BSSO, LeFort I or Bimax
Exclusion criteria:
- Transgender patients
- Other facial surgery's
- Deviant medication
- Cleft patients
- Lot of facial hair
- 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.
- Conditions
- Postoperative Care/Methods, Drainage/Methods, Edema/Prevention & Control, Orthognathic Surgical Procedures/Adverse Effects
- Being tested
- manual lymphatic drainage
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manual lymphatic drainageOther
The intervention group received the same conventional postoperative cares as the control group, but also underwent 5 sessions of manual lymphatic drainage (MLD)
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Not described |
| intervention | Experimental | Not described Receives: Other: manual lymphatic drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Pain scores were assessed at 6 fixed time points after surgery 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.
Measured: 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
Swelling was assessed at 6 fixed time points after surgery using a five-point Likert-type Scale. Five possible answers could be checked: no swelling, almost no swelling, moderate swelling, pretty much swelling and very much swelling.
Measured: at the 3th, 7th and 14th day after surgery, as well as 1 month, 3 months and 6 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study startSep 2016
- Primary completionApr 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative Care/MethodsStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tandheelkunde, University Hospital, Ghent
- Investigators
- Guy De Pauw, Prof. Dr., Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682159
- Sponsor's protocol ID
- B670201629310
- Status last verified
- Jan 2019
- First submitted
- 12 Sep 2018
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28872503Szolnoky 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.
PubMed 18062616
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Manual Lymphatic Drainage on Swelling After Orthognathic Surgery - a Qualitative and 3D Facial Analysis.
- ClinicalTrials.gov ID
- NCT03682159
- Acronym / sponsor ID
- B670201629310
- Conditions
- Postoperative Care/Methods, Drainage/Methods, Edema/Prevention & Control, Orthognathic Surgical Procedures/Adverse Effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Apr 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 24 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Age 14 - 65 years
- ASA score I
- BSSO, LeFort I or Bimax
Exclusion criteria:
- Transgender patients
- Other facial surgery's
- Deviant medication
- Cleft patients
- Lot of facial hair
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | – |
| intervention | Experimental | Other: manual lymphatic drainage |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age 14 - 65 years
- ASA score I
- BSSO, LeFort I or Bimax
Key exclusion criteria (6 listed)
- Transgender patients
- Other facial surgery's
- Deviant medication
- Cleft patients
- Lot of facial hair
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| manual lymphatic drainageThe intervention group received the same conventional postoperative cares as the control group, but also underwent 5 sessions of manual lymphatic drainage (MLD) | Other | intervention |
Primary outcome
Change of swelling after orthognathic surgery assessed by 3D face scans
Time frame: 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.
2 secondary outcomes
Questionnaire with a 100 millimeter Visual Analogue Scale to measure perceived pain
Time frame: 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
Time frame: at the 3th, 7th and 14th day after surgery, as well as 1 month, 3 months and 6 months after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Background: PubMed 28872503Yaedu 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.
- Background: PubMed 18062616Szolnoky 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guy De Pauw, Prof. Dr. principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing manual lymphatic drainage in people with Postoperative Care/Methods and Drainage/Methods, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of swelling after orthognathic surgery assessed by 3D face scans (time frame: At the 3th, 7th and 14th day after surgery, as well as 1 month, 3 months and 6 months after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03682159, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.