An interventional study of Very low calorie diet in Morbid Obesity, sponsored by Christiana Care Health Services. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-28.
Sponsored by Christiana Care Health Services · Not applicable, Interventional, and Prevention
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.
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.
922 studies on the registry are indexed under Obesity, Morbid; 172 are open to participants now.
This study's enrollment of 58 is close to the median of 60 across 590 interventional studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →Christiana Care Health Services is the lead sponsor of 94 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Patients will be excluded from the study if they have any of the following:
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 control group will continue a regular diet until the day before surgery.
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.
Reduction in Post Operative Complications
Pulmonary, cardiac and surgical complications using data collected from inpatient and outpatient charting
Time frame: 30-days post operatively
Feasibility of the Study
Patient satisfaction and compliance based on patient surveys administered prior to discharge from the hospital
Time frame: 2 weeks
Effect on Perioperative BMI
Difference in pre operative and perioperative BMI, in kg/m\^2
Time frame: 2 weeks
Effect on blood glucose levels
Difference in pre operative and perioperative blood glucose levels
Time frame: 2 weeks
Effect on insulin administration
Difference in pre operative and perioperative insulin administration, in units
Time frame: 2 weeks
Effect on operative times
Comparative operative times, in minutes, between control and intervention
Time frame: Day of surgery
Effect on operative blood loss
Comparative operative blood loss, in milliliters, between control and intervention
Time frame: Day of surgery
Effect on surgeon perceived difficulty
Comparative surgeon perceived difficulty between control and intervention utilizing a surgeon and procedure specific survey
Time frame: Day of surgery
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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