Utilization of Very Low Calorie Diet in Obese General Surgery Patients

Sponsor

Christiana Care Health Services (Other)

Overall Status

Completed

CT.gov ID

NCT03553849

Collaborator

(none)

Enrollment

Location

Arms

27.2

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Morbid Obesity	Dietary Supplement: Very low calorie diet	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

58 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Double (Care Provider, Outcomes Assessor)

Masking Description:

The operative surgeons will be blinded to the randomization. The patient, by nature of the study, will not be blinded.

Primary Purpose:

Prevention

Official Title:

Utilization of Very Low Calorie Diet in Obese General Surgery Patients

Actual Study Start Date :

Sep 24, 2018

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

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.	Dietary Supplement: 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.
No Intervention: Standard Preop Diet The control group will continue a regular diet until the day before surgery.

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.

Dietary Supplement: 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.

No Intervention: Standard Preop Diet

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

Outcome Measures

Primary Outcome Measures

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

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 blood glucose levels [2 weeks]
Difference in pre operative and perioperative blood glucose levels
Effect on insulin administration [2 weeks]
Difference in pre operative and perioperative insulin administration, in units
Effect on operative times [Day of surgery]
Comparative operative times, in minutes, between control and intervention
Effect on operative blood loss [Day of surgery]
Comparative operative blood loss, in milliliters, between control and intervention
Effect on surgeon perceived difficulty [Day of surgery]
Comparative surgeon perceived difficulty between control and intervention utilizing a surgeon and procedure specific survey

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Christiana Care Health System	Newark	Delaware	United States	19713

Sponsors and Collaborators

Christiana Care Health Services

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Christiana Care Health Services

ClinicalTrials.gov Identifier:

NCT03553849

Other Study ID Numbers:

DDD603893 / 077069243

First Posted:

Jun 12, 2018

Last Update Posted:

Jan 28, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Christiana Care Health Services

Very low calorie diet

General surgery

Additional relevant MeSH terms:

Obesity, Morbid

Study Results

No Results Posted as of Jan 28, 2021