- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03553849
Utilization of Very Low Calorie Diet in Obese General Surgery Patients
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Delaware
-
Newark, Delaware, United States, 19713
- Christiana Care Health System
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction in Post Operative Complications
Time Frame: 30-days post operatively
|
Pulmonary, cardiac and surgical complications using data collected from inpatient and outpatient charting
|
30-days post operatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of the Study
Time Frame: 2 weeks
|
Patient satisfaction and compliance based on patient surveys administered prior to discharge from the hospital
|
2 weeks
|
Effect on Perioperative BMI
Time Frame: 2 weeks
|
Difference in pre operative and perioperative BMI, in kg/m^2
|
2 weeks
|
Effect on blood glucose levels
Time Frame: 2 weeks
|
Difference in pre operative and perioperative blood glucose levels
|
2 weeks
|
Effect on insulin administration
Time Frame: 2 weeks
|
Difference in pre operative and perioperative insulin administration, in units
|
2 weeks
|
Effect on operative times
Time Frame: Day of surgery
|
Comparative operative times, in minutes, between control and intervention
|
Day of surgery
|
Effect on operative blood loss
Time Frame: Day of surgery
|
Comparative operative blood loss, in milliliters, between control and intervention
|
Day of surgery
|
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
|
Day of surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Caitlin A Halbert, DO, MS, Christiana Care Health Services
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DDD603893 / 077069243
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Morbid Obesity
-
ClinTrio Ltd.UnknownMorbid Obesity Requiring Bariatric SurgeryBelgium, Germany, Portugal, Austria, Netherlands, Poland, Saudi Arabia
-
Centre Hospitalier Universitaire de NiceCompletedMorbid Obesity D009765France
-
Shanghai Jiao Tong University School of MedicineUnknown
-
Hospices Civils de LyonCentre de Recherche en Nutrition Humaine Rhone-Alpe; Institut National de Recherche... and other collaboratorsRecruiting
-
Endolumik, IncWest Virginia UniversityNot yet recruitingMorbid ObesityUnited States
-
Rijnstate HospitalRecruiting
-
Laval UniversityCentre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie...Recruiting
-
University of WashingtonUnited States Department of DefenseWithdrawn
-
Helsinki University Central HospitalActive, not recruiting
-
IHU StrasbourgWithdrawnMorbid Obesity
Clinical Trials on Very low calorie diet
-
Hartford HospitalNot yet recruiting
-
Indiana UniversityCompleted
-
University of Kansas Medical CenterCompletedObstructive Sleep ApneaUnited States
-
Norwegian University of Science and TechnologyMonash University; Portuguese Research CouncilCompleted
-
Special Hospital for Extended Treatment of Duga...Institute for Medical Research and Occupational Health; University of ZagrebCompletedObesity | Weight Loss | DNA DamageCroatia
-
Special Hospital for Extended Treatment of Duga...Institute for Medical Research and Occupational Health; University of ZagrebCompletedObesity | Weight Loss | DNA DamageCroatia
-
The University of The West IndiesUnknownDiabetes Mellitus Type 2 in ObeseBarbados
-
The Hospital of VestfoldUniversity of Oslo; AstraZenecaActive, not recruiting
-
Mahidol UniversityEnrolling by invitation
-
Istituto Ortopedico RizzoliRecruitingKnee Osteoarthritis | FibromyalgiaItaly