Clinical trial NCT03553849: 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
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Keywords: Very low calorie diet
General surgery
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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:

  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.

Primary outcomes:
measure: Reduction in Post Operative Complications
timeFrame: 30-days post operatively
Secondary outcomes:
measure: Feasibility of the Study
timeFrame: 2 weeks
measure: Effect on Perioperative BMI
timeFrame: 2 weeks
measure: Effect on blood glucose levels
timeFrame: 2 weeks
measure: Effect on insulin administration
timeFrame: 2 weeks
measure: Effect on operative times
timeFrame: Day of surgery
measure: Effect on operative blood loss
timeFrame: Day of surgery
measure: Effect on surgeon perceived difficulty
timeFrame: Day of surgery
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Health System
state: Delaware
Study officials:
affiliation: Christiana Care Health Services
name: Caitlin A Halbert, DO, MS
role: PRINCIPAL_INVESTIGATOR
References: