Utilization of Very Low Calorie Diet in Obese General Surgery Patients

Morbid Obesity Clinical Trial

Official title:

Utilization of Very Low Calorie Diet in Obese General Surgery Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03553849
• Other study ID #: DDD603893 / 077069243
• Status: Completed
• Phase: N/A
• Start date: September 24, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2021
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

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.

Locations

Country	Name	City	State
United States	Christiana Care Health System	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Christiana Care Health Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Post Operative Complications	Pulmonary, cardiac and surgical complications using data collected from inpatient and outpatient charting	30-days post operatively
Secondary	Feasibility of the Study	Patient satisfaction and compliance based on patient surveys administered prior to discharge from the hospital	2 weeks
Secondary	Effect on Perioperative BMI	Difference in pre operative and perioperative BMI, in kg/m^2	2 weeks
Secondary	Effect on blood glucose levels	Difference in pre operative and perioperative blood glucose levels	2 weeks
Secondary	Effect on insulin administration	Difference in pre operative and perioperative insulin administration, in units	2 weeks
Secondary	Effect on operative times	Comparative operative times, in minutes, between control and intervention	Day of surgery
Secondary	Effect on operative blood loss	Comparative operative blood loss, in milliliters, between control and intervention	Day of surgery
Secondary	Effect on surgeon perceived difficulty	Comparative surgeon perceived difficulty between control and intervention utilizing a surgeon and procedure specific survey	Day of surgery