Utilization of Very Low Calorie Diet in Obese General Surgery Patients

Christiana Care Health Services

Status: Completed

Conditions: Morbid Obesity

Treatments: Dietary Supplement: Very low calorie diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03553849

DDD603893 / 077069243

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

58 participants in 2 patient groups

Very Low Calorie Diet

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Very low calorie diet

Standard Preop Diet

No Intervention group

Description:

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