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Completed

NCT Number: NCT03553849

Utilization of Very Low Calorie Diet in Obese General Surgery Patients

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.

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Key information

Conditions

Morbid Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Christiana Care Health System

Newark, Delaware, 19713, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Very Low Calorie Diet

Dietary Supplement

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Christiana Care Health Services

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 12, 2018
Registry last updated
Jan 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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