Morbid Obesity
Conditions
Keywords
Very low calorie diet, General surgery
Brief summary
The investigators are studying the use of a two-week very low calorie diet (VLCD) in obese general surgery patients in a randomized single-blinded trial. The investigators hypothesize that the VLCD will positively impact the perceived surgical difficulty, operative time, hospital length of stay and 30-day complications. Additionally, the investigators anticipate reduced perioperative blood glucose levels and a reduced need for perioperative insulin administration.
Detailed description
The investigators' objective for this project is to determine the impact of a preoperative VLCD on outcomes for patients undergoing elective general surgery. Included are patients who are obese, BMI \>30, and scheduled by a Christiana Care-employed general surgeon for elective general surgery. Eligible patients are those scheduled for elective cholecystectomy, ventral or incisional hernia, umbilical hernia, and inguinal hernia surgery. The investigators will also be determining the feasibility of introducing a preoperative VLCD for patients undergoing elective general surgery in a Community Hospital setting.
Interventions
DIETARY_SUPPLEMENTVery low calorie diet
The VLCD is a prescribed diet with well-balanced macro and micronutrients. It is intended for significant weight loss in a short period of time, is intended only for the extremely obese, and must be completed under the supervision of a trained physician.
Sponsors
Christiana Care Health Services
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
The operative surgeons will be blinded to the randomization. The patient, by nature of the study, will not be blinded.
Intervention model description
The patient will be randomized into the treatment or control arm by the research team. If they are randomized into the treatment arm, they will be prescribed with a 2-week VLCD that will begin 2 weeks prior to the scheduled elective surgery.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients who are obese, BMI \>30, and scheduled by a Christiana Care-employed general surgeon for elective general surgery. * Patients between the ages of 18 and 65. * Patients scheduled for elective cholecystectomy, ventral or incisional hernia, umbilical hernia, and inguinal hernia surgery.
Exclusion criteria
* Patients will be excluded from the study if they have any of the following: 1. Recent myocardial infarction (3-6 months). 2. History of cerebral vascular accident (stroke). 3. Diabetes mellitus with a history of severe ketoacidosis. 4. Patients on SGLT2 inhibitors (glifozins) without insulin 5. Chronic use of steroids, greater than 20mg daily. 6. Bleeding peptic ulcer (unless there is radiological evidence of healing 6 months prior to entry). 7. A psychiatric history that includes suicide attempts and anyone taking psychotropic drugs, including lithium carbonate. 8. Active thrombophlebitis (or any other condition where decreased blood volume would put the patient at risk). * In addition, patients who are pregnant are excluded. If status is unknown, a pregnancy test will be required prior to the start of the VLCD.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Post Operative Complications | 30-days post operatively | Pulmonary, cardiac and surgical complications using data collected from inpatient and outpatient charting |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect on Perioperative BMI | 2 weeks | Difference in pre operative and perioperative BMI, in kg/m\^2 |
| Effect on blood glucose levels | 2 weeks | Difference in pre operative and perioperative blood glucose levels |
| Effect on insulin administration | 2 weeks | Difference in pre operative and perioperative insulin administration, in units |
| Feasibility of the Study | 2 weeks | Patient satisfaction and compliance based on patient surveys administered prior to discharge from the hospital |
| Effect on operative blood loss | Day of surgery | Comparative operative blood loss, in milliliters, between control and intervention |
| Effect on surgeon perceived difficulty | Day of surgery | Comparative surgeon perceived difficulty between control and intervention utilizing a surgeon and procedure specific survey |
| Effect on operative times | Day of surgery | Comparative operative times, in minutes, between control and intervention |
Countries
United States
Outcome results
None listed