Systematic Dietary Interventions to Minimize Postoperative Weight Loss and Enhance Recovery Following Orthognathic Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Aalborg University Hospital
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Change from baseline in weight in kilogram after orthognatic surgery
Study Overview
Brief Summary
Objectives This randomized controlled trial aimed to assess whether structured dietary interventions, implemented both before and after orthognathic surgery, could minimize postoperative weight loss and thereby enhance recovery during the first eight weeks.
Material and Methods The study was conducted at Aalborg University Hospital, Denmark, from April 2017 to April 2022, involving patients undergoing single- or bimaxillary surgery. Participants were randomly allocated into two intervention groups receiving nutritional supplements and one control group. Body composition was assessed using a Body Composition Analyzer at five time points: pre-surgery examination, admission, and follow-ups weeks 1, 3, and 8. Primary outcome was weight, secondary outcomes included BMI, fat mass, fat-free mass, total body water, and visceral fat rating. Additional data were collected on age, gender, type of surgery, and hospitalization duration.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients of both sexes with dentofacial deformities who underwent single- or bimaxillary surgery (Le Fort I osteotomy and/or bilateral sagittal split osteotomy) were included in the study.
Exclusion Criteria
- •Patients not willing to complete the planned treatment in the intervention groups.
Arms & Interventions
Controle
Usual care
G-tube administered Nutrition and Protein drinks
Nutrition supplement: G-tube administered Nutrition and Protein drinks
Intervention: Intervention group receiving nutritional supplements through G-tube and Protein drinks (Other)
Protein drink
Nutrition supplement: Protein drink
Intervention: Intervention group receiving nutritional supplements through Protein drinks (Other)
Outcomes
Primary Outcomes
Change from baseline in weight in kilogram after orthognatic surgery
Time Frame: From enrollment, (14 days before surgery), to 8 weeks after surgery.
Weight changes was the primary measure of interest, assessed using the Tanita BC-418 Segmental Body Composition Analyzer. Measurements were taken during scheduled hospital appointments; the pre-surgery examination, admission interview, and follow-up visits at week 1-, 3- and 8.
Secondary Outcomes
No secondary outcomes reported
Investigators
Marie Germund Nielsen
Assistant professor
Aalborg University Hospital