search
Back to results

Utilization of Very Low Calorie Diet in Obese General Surgery Patients

Primary Purpose

Morbid Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Very low calorie diet
Sponsored by
Christiana Care Health Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Morbid Obesity focused on measuring Very low calorie diet, General surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Christiana Care Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Very Low Calorie Diet

Standard Preop Diet

Arm 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.

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

Outcomes

Primary Outcome Measures

Reduction in Post Operative Complications
Pulmonary, cardiac and surgical complications using data collected from inpatient and outpatient charting

Secondary Outcome Measures

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

Full Information

First Posted
April 11, 2018
Last Updated
January 27, 2021
Sponsor
Christiana Care Health Services
search

1. Study Identification

Unique Protocol Identification Number
NCT03553849
Brief Title
Utilization of Very Low Calorie Diet in Obese General Surgery Patients
Official Title
Utilization of Very Low Calorie Diet in Obese General Surgery Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 24, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Christiana Care Health Services

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
Very low calorie diet, General surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The patient will be randomized into the treatment or control arm by the research team. 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.
Masking
Care ProviderOutcomes Assessor
Masking Description
The operative surgeons will be blinded to the randomization. The patient, by nature of the study, will not be blinded.
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Very Low Calorie Diet
Arm Type
Experimental
Arm 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.
Arm Title
Standard Preop Diet
Arm Type
No Intervention
Arm Description
The control group will continue a regular diet until the day before surgery.
Intervention Type
Dietary Supplement
Intervention Name(s)
Very low calorie diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction in Post Operative Complications
Description
Pulmonary, cardiac and surgical complications using data collected from inpatient and outpatient charting
Time Frame
30-days post operatively
Secondary Outcome Measure Information:
Title
Feasibility of the Study
Description
Patient satisfaction and compliance based on patient surveys administered prior to discharge from the hospital
Time Frame
2 weeks
Title
Effect on Perioperative BMI
Description
Difference in pre operative and perioperative BMI, in kg/m^2
Time Frame
2 weeks
Title
Effect on blood glucose levels
Description
Difference in pre operative and perioperative blood glucose levels
Time Frame
2 weeks
Title
Effect on insulin administration
Description
Difference in pre operative and perioperative insulin administration, in units
Time Frame
2 weeks
Title
Effect on operative times
Description
Comparative operative times, in minutes, between control and intervention
Time Frame
Day of surgery
Title
Effect on operative blood loss
Description
Comparative operative blood loss, in milliliters, between control and intervention
Time Frame
Day of surgery
Title
Effect on surgeon perceived difficulty
Description
Comparative surgeon perceived difficulty between control and intervention utilizing a surgeon and procedure specific survey
Time Frame
Day of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: Recent myocardial infarction (3-6 months). History of cerebral vascular accident (stroke). Diabetes mellitus with a history of severe ketoacidosis. Patients on SGLT2 inhibitors (glifozins) without insulin Chronic use of steroids, greater than 20mg daily. Bleeding peptic ulcer (unless there is radiological evidence of healing 6 months prior to entry). A psychiatric history that includes suicide attempts and anyone taking psychotropic drugs, including lithium carbonate. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caitlin A Halbert, DO, MS
Organizational Affiliation
Christiana Care Health Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christiana Care Health System
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Utilization of Very Low Calorie Diet in Obese General Surgery Patients

We'll reach out to this number within 24 hrs