Utilization of Very Low Calorie Diet in Obese General Surgery Patients

• ClinicalTrials.gov Identifier: NCT03553849
• Recruitment Status: Completed
• First Posted: June 12, 2018
• Last Update Posted: January 28, 2021
• Sponsor: Christiana Care Health Services
• Information provided by (Responsible Party): Christiana Care Health Services

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	Not Applicable

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 (Clinical Trial)
• 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.
• 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: September 24, 2018
• Actual Primary Completion Date: December 31, 2020
• Actual Study Completion Date: December 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.

Outcome Measures

Primary Outcome Measures :

1. Reduction in Post Operative Complications [ Time Frame: 30-days post operatively ]
   Pulmonary, cardiac and surgical complications using data collected from inpatient and outpatient charting

Secondary Outcome Measures :

1. Feasibility of the Study [ Time Frame: 2 weeks ]
   Patient satisfaction and compliance based on patient surveys administered prior to discharge from the hospital
2. Effect on Perioperative BMI [ Time Frame: 2 weeks ]
   Difference in pre operative and perioperative BMI, in kg/m^2
3. Effect on blood glucose levels [ Time Frame: 2 weeks ]
   Difference in pre operative and perioperative blood glucose levels
4. Effect on insulin administration [ Time Frame: 2 weeks ]
   Difference in pre operative and perioperative insulin administration, in units
5. Effect on operative times [ Time Frame: Day of surgery ]
   Comparative operative times, in minutes, between control and intervention
6. Effect on operative blood loss [ Time Frame: Day of surgery ]
   Comparative operative blood loss, in milliliters, between control and intervention
7. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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:

  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.

Contacts and Locations

Locations

United States, Delaware

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

More Information

• Responsible Party: Christiana Care Health Services
• ClinicalTrials.gov Identifier: NCT03553849
• Other Study ID Numbers: DDD603893 / 077069243
• First Posted: June 12, 2018
• Last Update Posted: January 28, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Christiana Care Health Services:

Very low calorie diet; General surgery

Additional relevant MeSH terms:

Obesity, Morbid; Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight