Utilization of Very Low Calorie Diet in Obese General Surgery Patients



Status:Recruiting
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 65
Updated:3/14/2019
Start Date:September 24, 2018
End Date:August 1, 2019
Contact:Caitlin A Halbert, DO, MS
Email:caitlin.a.halbert@christianacare.org
Phone:3023207175

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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.

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.
We found this trial at
1
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Newark, Delaware 19713
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Newark, DE
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