Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Very Low Calorie Diet | Experimental | 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. Patients will be required to pay for the meal replacements. |
|
| Standard Preop Diet | No Intervention | The control group will continue a regular diet until the day before surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Very low calorie diet | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Post Operative Complications | Pulmonary, cardiac and surgical complications using data collected from inpatient and outpatient charting | 30-days post operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the Study | Patient satisfaction and compliance based on patient surveys administered prior to discharge from the hospital | 2 weeks |
| Effect on Perioperative BMI | Difference in pre operative and perioperative BMI, in kg/m^2 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patients will be excluded from the study if they have any of the following:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Caitlin A Halbert, DO, MS | Christiana Care Health Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christiana Care Health System | Newark | Delaware | 19713 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
Not provided
Not provided
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.
Not provided
Not provided
The operative surgeons will be blinded to the randomization. The patient, by nature of the study, will not be blinded.
|
| 2 weeks |
| Effect on blood glucose levels | Difference in pre operative and perioperative blood glucose levels | 2 weeks |
| Effect on insulin administration | Difference in pre operative and perioperative insulin administration, in units | 2 weeks |
| Effect on operative times | Comparative operative times, in minutes, between control and intervention | Day of surgery |
| Effect on operative blood loss | Comparative operative blood loss, in milliliters, between control and intervention | Day of surgery |
| Effect on surgeon perceived difficulty | Comparative surgeon perceived difficulty between control and intervention utilizing a surgeon and procedure specific survey | Day of surgery |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |