Utilization of Very Low Calorie Diet in Obese General Surgery Patients

January 27, 2021 updated by: Christiana Care Health Services
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.

Study Overview

Status

Completed

Conditions

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 Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Delaware
      • Newark, Delaware, United States, 19713
        • Christiana Care Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
No Intervention: Standard Preop Diet
The control group will continue a regular diet until the day before surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in Post Operative Complications
Time Frame: 30-days post operatively
Pulmonary, cardiac and surgical complications using data collected from inpatient and outpatient charting
30-days post operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of the Study
Time Frame: 2 weeks
Patient satisfaction and compliance based on patient surveys administered prior to discharge from the hospital
2 weeks
Effect on Perioperative BMI
Time Frame: 2 weeks
Difference in pre operative and perioperative BMI, in kg/m^2
2 weeks
Effect on blood glucose levels
Time Frame: 2 weeks
Difference in pre operative and perioperative blood glucose levels
2 weeks
Effect on insulin administration
Time Frame: 2 weeks
Difference in pre operative and perioperative insulin administration, in units
2 weeks
Effect on operative times
Time Frame: Day of surgery
Comparative operative times, in minutes, between control and intervention
Day of surgery
Effect on operative blood loss
Time Frame: Day of surgery
Comparative operative blood loss, in milliliters, between control and intervention
Day of surgery
Effect on surgeon perceived difficulty
Time Frame: Day of surgery
Comparative surgeon perceived difficulty between control and intervention utilizing a surgeon and procedure specific survey
Day of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Caitlin A Halbert, DO, MS, Christiana Care Health Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2018

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

April 11, 2018

First Submitted That Met QC Criteria

May 30, 2018

First Posted (Actual)

June 12, 2018

Study Record Updates

Last Update Posted (Actual)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 27, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • DDD603893 / 077069243

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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