Utilization of Very Low Calorie Diet in Obese General Surgery Patients

Not Applicable

Completed

• Conditions: Morbid Obesity
• Interventions: Dietary Supplement: Very low calorie diet

• Registration Number: NCT03553849
• Lead Sponsor: Christiana Care Health Services

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.

Study Timeline

• Study First Submitted: 2018-04-11
• Study First Submitted QC: 2018-05-30
• Study First Posted: 2018-06-12
• Study Start: 2018-09-24
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-27
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Very Low Calorie Diet	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.

Primary Outcome Measures

Name	Time	Method
Reduction in Post Operative Complications	30-days post operatively	Pulmonary, cardiac and surgical complications using data collected from inpatient and outpatient charting

Secondary Outcome Measures

Name	Time	Method
Feasibility of the Study	2 weeks	Patient satisfaction and compliance based on patient surveys administered prior to discharge from the hospital
Effect on Perioperative BMI	2 weeks	Difference in pre operative and perioperative BMI, in kg/m\^2
Effect on operative times	Day of surgery	Comparative operative times, in minutes, between control and intervention
Effect on blood glucose levels	2 weeks	Difference in pre operative and perioperative blood glucose levels
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 insulin administration	2 weeks	Difference in pre operative and perioperative insulin administration, in units
Effect on operative blood loss	Day of surgery	Comparative operative blood loss, in milliliters, between control and intervention

Trial Locations

Locations (1)

Christiana Care Health System; 🇺🇸 Newark, Delaware, United States