- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02872493
Small Bowel Length and Bariatric Surgery Outcomes
Observational Study of the Effect of Small Intestine Length on Bariatric Surgical Patient Outcomes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients undergoing laparoscopic bariatric surgery, either vertical sleeve gastrectomy or Roux-en-Y gastric bypass
- Able to give informed consent
Exclusion Criteria:
- Prior small intestine resection.
- Inability to safely obtain total small intestinal length measurements in the operating room.
- Any small bowel tethering due to intestinal adhesions identified in the operating room.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
RYGB
Roux-en-Y Gastric Bypass - these are patients that undergo a Roux-en-Y gastric bypass operation for their bariatric operation.
|
The total length of the small bowel with be measured at the time of the bariatric surgical operation.
|
VSG
Vertical Sleeve Gastrectomy - these are patients that undergo a vertical sleeve gastrectomy operation for their bariatric operation.
|
The total length of the small bowel with be measured at the time of the bariatric surgical operation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Weight
Time Frame: Up to 10 years postoperatively as measured for routine clinical care
|
Body weight will be measured preoperatively (within 30 days of the operation) as the baseline body weight, then postoperatively up to ten years from the time of initial surgery. Measurements will be made per routine clinical care and not solely for research purposes. Exact time points before and after surgery that body weight will be measured, except for the day of surgery, will differ between patients in the study. Change in body weight over time will be measured annually, adjusted for baseline body weight at the time of surgery. Regression will be used to test for a significant interaction of "total bowel length" and "body weight" over time in the patient cohorts (RYGB vs. VSG) - this is our primary outcome measurement. We are examining whether there is a significant interaction between any change in body weight over time and the small bowel length in the patient cohorts. |
Up to 10 years postoperatively as measured for routine clinical care
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vitamin A
Time Frame: Up to 10 years postoperatively
|
Other pre-specified outcomes will be analyzed annually, adjusted for baseline measurements.
Similar to the primary endpoint, data will be analyzed as continuous variables and tested for an interaction between total bowel length and the nutritional variable of interest.
These other nutritional outcomes will vary depending on the clinical course of the individual patients in this observational study.
Thus, time points that patients will have these variables measured will not be exactly the same across patients and will depend on the clinical care of the individual patient.
|
Up to 10 years postoperatively
|
Vitamin D
Time Frame: Up to 10 years postoperatively
|
Other pre-specified outcomes will be analyzed annually, adjusted for baseline measurements.
Similar to the primary endpoint, data will be analyzed as continuous variables and tested for an interaction between total bowel length and the nutritional variable of interest.
These other nutritional outcomes will vary depending on the clinical course of the individual patients in this observational study.
Thus, time points that patients will have these variables measured will not be exactly the same across patients and will depend on the clinical care of the individual patient.
|
Up to 10 years postoperatively
|
Vitamin E
Time Frame: Up to 10 years postoperatively
|
Other pre-specified outcomes will be analyzed annually, adjusted for baseline measurements.
Similar to the primary endpoint, data will be analyzed as continuous variables and tested for an interaction between total bowel length and the nutritional variable of interest.
These other nutritional outcomes will vary depending on the clinical course of the individual patients in this observational study.
Thus, time points that patients will have these variables measured will not be exactly the same across patients and will depend on the clinical care of the individual patient.
|
Up to 10 years postoperatively
|
Vitamin B1
Time Frame: Up to 10 years postoperatively
|
Other pre-specified outcomes will be analyzed annually, adjusted for baseline measurements.
Similar to the primary endpoint, data will be analyzed as continuous variables and tested for an interaction between total bowel length and the nutritional variable of interest.
These other nutritional outcomes will vary depending on the clinical course of the individual patients in this observational study.
Thus, time points that patients will have these variables measured will not be exactly the same across patients and will depend on the clinical care of the individual patient.
|
Up to 10 years postoperatively
|
Vitamin B2
Time Frame: Up to 10 years postoperatively
|
Other pre-specified outcomes will be analyzed annually, adjusted for baseline measurements.
Similar to the primary endpoint, data will be analyzed as continuous variables and tested for an interaction between total bowel length and the nutritional variable of interest.
These other nutritional outcomes will vary depending on the clinical course of the individual patients in this observational study.
Thus, time points that patients will have these variables measured will not be exactly the same across patients and will depend on the clinical care of the individual patient.
|
Up to 10 years postoperatively
|
Vitamin B6
Time Frame: Up to 10 years postoperatively
|
Other pre-specified outcomes will be analyzed annually, adjusted for baseline measurements.
Similar to the primary endpoint, data will be analyzed as continuous variables and tested for an interaction between total bowel length and the nutritional variable of interest.
These other nutritional outcomes will vary depending on the clinical course of the individual patients in this observational study.
Thus, time points that patients will have these variables measured will not be exactly the same across patients and will depend on the clinical care of the individual patient.
|
Up to 10 years postoperatively
|
Vitamin B12
Time Frame: Up to 10 years postoperatively
|
Other pre-specified outcomes will be analyzed annually, adjusted for baseline measurements.
Similar to the primary endpoint, data will be analyzed as continuous variables and tested for an interaction between total bowel length and the nutritional variable of interest.
These other nutritional outcomes will vary depending on the clinical course of the individual patients in this observational study.
Thus, time points that patients will have these variables measured will not be exactly the same across patients and will depend on the clinical care of the individual patient.
|
Up to 10 years postoperatively
|
Iron
Time Frame: Up to 10 years postoperatively
|
Other pre-specified outcomes will be analyzed annually, adjusted for baseline measurements.
Similar to the primary endpoint, data will be analyzed as continuous variables and tested for an interaction between total bowel length and the nutritional variable of interest.
These other nutritional outcomes will vary depending on the clinical course of the individual patients in this observational study.
Thus, time points that patients will have these variables measured will not be exactly the same across patients and will depend on the clinical care of the individual patient.
|
Up to 10 years postoperatively
|
Parathyroid Hormone
Time Frame: Up to 10 years postoperatively
|
Other pre-specified outcomes will be analyzed annually, adjusted for baseline measurements.
Similar to the primary endpoint, data will be analyzed as continuous variables and tested for an interaction between total bowel length and the nutritional variable of interest.
These other nutritional outcomes will vary depending on the clinical course of the individual patients in this observational study.
Thus, time points that patients will have these variables measured will not be exactly the same across patients and will depend on the clinical care of the individual patient.
|
Up to 10 years postoperatively
|
Total Iron Binding Capacity
Time Frame: Up to 10 years postoperatively
|
Other pre-specified outcomes will be analyzed annually, adjusted for baseline measurements.
Similar to the primary endpoint, data will be analyzed as continuous variables and tested for an interaction between total bowel length and the nutritional variable of interest.
These other nutritional outcomes will vary depending on the clinical course of the individual patients in this observational study.
Thus, time points that patients will have these variables measured will not be exactly the same across patients and will depend on the clinical care of the individual patient.
|
Up to 10 years postoperatively
|
Ferritin
Time Frame: Up to 10 years postoperatively
|
Other pre-specified outcomes will be analyzed annually, adjusted for baseline measurements.
Similar to the primary endpoint, data will be analyzed as continuous variables and tested for an interaction between total bowel length and the nutritional variable of interest.
These other nutritional outcomes will vary depending on the clinical course of the individual patients in this observational study.
Thus, time points that patients will have these variables measured will not be exactly the same across patients and will depend on the clinical care of the individual patient.
|
Up to 10 years postoperatively
|
Collaborators and Investigators
Investigators
- Principal Investigator: Wayne J English, MD, Vanderbilt University Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
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
- 160971
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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