Effect of Steroid for the Postoperative Swelling After Orthognathic Surgery
Study Details
Study Description
Brief Summary
Postoperative swelling is one of most common concerns to plastic and oromaxillary surgeons after orthognathic surgery. The purpose of this study is to develop a steroid regimen protocol for minimizing postoperative facial swelling after orthognathic surgery.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Detailed Description
Postoperative swelling is an annoying problem after orthognathic surgery. There are two reasons to minimize postoperative swelling. The first is a functional consideration. Orthognathic surgery is performed in oromaxillary area, and consequently swelling in this area can compromise airway. The second is esthetic one, as patients feel uncomfortable and embarrassing with a swollen face. Reducing facial swelling after orthognathic surgery helps to reduce airway complication and patient down time.
Several methods are used to reduce postoperative facial swelling, including controlled hypotension during operation, meticulous operative procedures, postoperative facial ice packing, head elevation, and suction drainage. Perioperative use of steroid has been applied for reduction of facial swelling after oral surgery and 3rd molar extraction. Cyclooxygenase-1 (COX1) and COX2 have been reported to be important enzymes for inflammatory process, and steroids inhibit their synthesis, consequently reducing postoperative edema. Steroid has also been used to decrease edema after orthognathic surgery, as well as to reduce pain, nausea and vomiting.
There were three randomized controlled studies looking at the effect of steroid on postoperative facial swelling after orthognathic surgery, separately by Dr. Weber et al, Peillon et al, and Munro et al. However, the results were controversial. The first two studies concluded that the steroid use could reduce facial swelling. The other one did not find significant difference between the experimental and control groups. Another limitation of the previous studies was that they all used two-dimensional or non-objective methods for evaluation of the amount of swelling, which could be less accurate. Three-dimensional photogrammetry has been introduced in recent years, and has obtained satisfactory results over the conventional methods. The investigators have experience of applying the device for facial surface study, and the accuracy has been validated in our imaging laboratory.
The purpose of this study is to determine the effect of steroid for reduction of postoperative facial swelling determined by three-dimensional photographic method. 3dMD face scanner will be used. The 3-dimensional method makes no harm to patients. Patients will be seated during scanning and thus reducing possible inconvenience. There is no radiation hazard with this method. The image acquisition time is 2 milliseconds or less, and therefore no concern of motion artifacts. The first part of this study is to get information about the swelling curve after orthognathic surgery. 3dMD face scanning will be performed 5 times postoperatively every 12 hours after 24 hours of operation. When the postoperative timing of maximal facial swelling is obtained, the investigators will proceed to perform the second part of study, and the number of facial scanning is reduced. The second part of study involves recruiting 70 patients with prognathism. The patients will be carefully screened and selected by craniofacial surgeons. The patients will take preoperative and postoperative 3dMD image scanning. The recovery course and clinical outcome will be monitored. 3dMD face image data analysis will be performed for quantitative comparisons between the experimental and control groups.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Dexamethasone"low-dose" 5mg |
Drug: Dexamethasone"low-dose"
5mg
Other Names:
|
| Experimental: Dexamethasone"high-dose" 15mg |
Drug: Dexamethasone"high-dose"
15 mg
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Effect of Perioperative Steroid for the Postoperative Swelling After Orthognathic Surgery [1 year]
Measure of facial swelling will be performed using 3-dimensional photogrammetry. The 3d photo acquisition is non-invasive without radiation concern. The images will be taken before and after surgery to measure and compare the degree of facial swelling. Side effects from the steroid use are expected to be low under normal clinical dosage, but will also be monitored. Symptoms of wound infection, psychosis, and prolonged wound healing will be studied. There should be no long term complication, since the steroid use is one single dose.
Eligibility Criteria
Criteria
Inclusion Criteria:
- patients who receive LeFort I osteotomy of maxilla and bilateral sagittal split osteotomy of mandible
Exclusion Criteria:
-
patients with local or systemic diseases
-
patients taking aspirin, steroid, nonsteroidal anti-inflammatory drugs, or having contraindications for steroids
-
patients with history of psychosis
-
patients with active or chronic infection
-
patients with active or latent peptic ulcer
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chang Gung Memorial Hospital | Taoyuan | Taiwan | 333 |
Sponsors and Collaborators
- Chang Gung Memorial Hospital
Investigators
- Principal Investigator: Lun-Jou Lo, MD, Chang Gung Memorial Hospital
- Study Chair: Hye-Young Kim, MD, Chang Gung Memorial Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 99-2811-B-182A-003
- CGMH-IRB-100-2191B
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Dexamethasone"High-dose" | Dexamethasone"Low-dose" |
|---|---|---|
| Arm/Group Description | 15mg Dexamethasone"high-dose" : 15 mg | 5mg Dexamethasone"low-dose" : 5mg |
| Period Title: Overall Study | ||
| STARTED | 34 | 34 |
| COMPLETED | 31 | 25 |
| NOT COMPLETED | 3 | 9 |
Baseline Characteristics
| Arm/Group Title | Dexamethasone"High-dose" | Dexamethasone"Low-dose" | Total |
|---|---|---|---|
| Arm/Group Description | 15mg Dexamethasone"high-dose" : 15 mg | 5mg Dexamethasone"low-dose" : 5mg | Total of all reporting groups |
| Overall Participants | 31 | 25 | 56 |
| Age (Count of Participants) | |||
| <=18 years |
1
3.2%
|
5
20%
|
6
10.7%
|
| Between 18 and 65 years |
30
96.8%
|
20
80%
|
50
89.3%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
23.16
(4.19)
|
20.92
(4.79)
|
22.16
(4.6)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
15
48.4%
|
13
52%
|
28
50%
|
| Male |
16
51.6%
|
12
48%
|
28
50%
|
| Region of Enrollment (participants) [Number] | |||
| Taiwan |
31
100%
|
25
100%
|
56
100%
|
Outcome Measures
| Title | Effect of Perioperative Steroid for the Postoperative Swelling After Orthognathic Surgery |
|---|---|
| Description | Measure of facial swelling will be performed using 3-dimensional photogrammetry. The 3d photo acquisition is non-invasive without radiation concern. The images will be taken before and after surgery to measure and compare the degree of facial swelling. Side effects from the steroid use are expected to be low under normal clinical dosage, but will also be monitored. Symptoms of wound infection, psychosis, and prolonged wound healing will be studied. There should be no long term complication, since the steroid use is one single dose. |
| Time Frame | 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Dexamethasone"High-dose" | Dexamethasone"Low-dose" |
|---|---|---|
| Arm/Group Description | 15mg Dexamethasone"high-dose" : 15 mg | 5mg Dexamethasone"low-dose" : 5 mg |
| Measure Participants | 31 | 25 |
| 36 hours postoperatively |
167.06
(55.93)
|
190.73
(78.74)
|
| 1week postoperatively |
61.39
(30.14)
|
57.62
(36.13)
|
| 1month postoperatively |
29.85
(19.40)
|
19.34
(16.56)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Dexamethasone"High-dose", Dexamethasone"Low-dose" |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | >0.05 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Dexamethasone"Low-dose" | Dexamethasone"High-dose" | ||
| Arm/Group Description | 5mg Dexamethasone"low-dose": 5mg | 15mg Dexamethasone"high-dose": 15 mg | ||
All Cause Mortality |
||||
| Dexamethasone"Low-dose" | Dexamethasone"High-dose" | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Dexamethasone"Low-dose" | Dexamethasone"High-dose" | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/25 (0%) | 0/31 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Dexamethasone"Low-dose" | Dexamethasone"High-dose" | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/25 (0%) | 0/31 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Lun-Jou Lo, MD,Hye-Young Kim, MD |
|---|---|
| Organization | Chang Gung Memorial Hospital |
| Phone | |
| lunjoulo@cgmh.org.tw |
- 99-2811-B-182A-003
- CGMH-IRB-100-2191B