Utilization of Very Low Calorie Diet in Obese General Surgery Patients
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|ClinicalTrials.gov Identifier: NCT03553849|
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : July 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Morbid Obesity||Dietary Supplement: Very low calorie diet||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|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.|
|Official Title:||Utilization of Very Low Calorie Diet in Obese General Surgery Patients|
|Actual Study Start Date :||September 24, 2018|
|Estimated Primary Completion Date :||June 1, 2020|
|Estimated Study Completion Date :||August 1, 2020|
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.
- Reduction in Post Operative Complications [ Time Frame: 30-days post operatively ]Pulmonary, cardiac and surgical complications using data collected from inpatient and outpatient charting
- Feasibility of the Study [ Time Frame: 2 weeks ]Patient satisfaction and compliance based on patient surveys administered prior to discharge from the hospital
- Effect on Perioperative BMI [ Time Frame: 2 weeks ]Difference in pre operative and perioperative BMI, in kg/m^2
- Effect on blood glucose levels [ Time Frame: 2 weeks ]Difference in pre operative and perioperative blood glucose levels
- Effect on insulin administration [ Time Frame: 2 weeks ]Difference in pre operative and perioperative insulin administration, in units
- Effect on operative times [ Time Frame: Day of surgery ]Comparative operative times, in minutes, between control and intervention
- Effect on operative blood loss [ Time Frame: Day of surgery ]Comparative operative blood loss, in milliliters, between control and intervention
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553849
|Contact: Caitlin A Halbert, DO, MSfirstname.lastname@example.org|
|United States, Delaware|
|Christiana Care Health System||Recruiting|
|Newark, Delaware, United States, 19713|
|Contact: Caitlin A Halbert, DO, MS|
|Principal Investigator:||Caitlin A Halbert, DO, MS||Christiana Care Health Services|