Utilization of Very Low Calorie Diet in Obese General Surgery Patients

NCT ID: NCT03553849

Last Updated: 2021-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-24
• Study Completion Date: 2020-12-31

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.

Conditions

Morbid Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Very Low Calorie Diet

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.

Group Type: EXPERIMENTAL

Very low calorie diet

Intervention Type: 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.

Standard Preop Diet

The control group will continue a regular diet until the day before surgery.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Very 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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Christiana Care Health Services

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caitlin A Halbert, DO, MS

Role: PRINCIPAL_INVESTIGATOR

Christiana Care Health Services

Locations

Christiana Care Health System

Newark, Delaware, United States

Countries

United States

Other Identifiers

DDD603893 / 077069243

Identifier Type: -

Identifier Source: org_study_id