- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03648307
Long Term Effect of Splenectomy on Metabolism
Long-term Effect of Splenectomy on Metabolism, a Retrospective Cohort Study
Study Overview
Detailed Description
A list was made of patients who had gone through trauma splenectomy or bowel resection due to bowel obstruction in our center between July 2008 and July 2013. Patients were divided into two groups: trauma splenectomy (exposed group) and bowel resection (unexposed group).
All patients were followed up for 5-10 years. Of the 243 splenectomized patients, 90 patients who met our study criteria were willing to participate. Of 152 patients with bowel resection, 64 were willing to participate. Records of patients at the time of surgery were retrieved from hospital archive of patients' records. Patients were invited to an office meeting for assessment of blood pressure, BMI and a general physical examination and history taking. An appointment was made for drawing blood samples for measurement of lipid profile, Hb A1C and fasting blood sugar.
Exclusion criteria:
1. Disturbed lipid profile at the time of surgery, 2. Disturbed blood glucose levels at the time of surgery, 3. History of high blood pressure prior to surgery, 4. Use of any hyperglycemogenic agent during the follow up period, 5. BMI>= 25 at the time of surgery, 6. History of diseases potentially affecting blood glucose, e.g. hyperthyroidism, Cushing syndrome, 7. Accidental pancreatic damage during surgery, 8. Resection of >10 cm of small bowel and 9. History of malignancy or radiotherapy (criteria 8 and 9 were specific to unexposed group).
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- trauma splenectomy or bowel resection due to obstruction between July 2008 and July 2013
Exclusion Criteria:
- disturbed lipid profile at the time of surgery
- disturbed blood glucose at the time of surgery
- history of high blood pressure at the time of surgery
- use of any hyperglcemogenic agent during the follow up
- BMI>= 25 at the time of surgery
- history of diseases that can affect blood glucose levels
- accidental pancreatic damage during surgery
- resection of > 10 cm of small bowel (for bowel resection group)
- history of malignancy or radiotherapy (for bowel resection group)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Trauma splenectomized
Patients who had gone through trauma splenectomy.
BMI, lipid profile, blood pressure and glucose tolerance of patients were assessed.
Hb A1C and lipid profile were assessed through blood sampling.
|
Blood sample for Hb A1C and lipid profile, blood pressure and BMI
Other Names:
|
Bowel resection
Patients who had gone through bowel resection due to obstruction.
BMI, lipid profile, blood pressure and glucose tolerance of patients were assessed.
Hb A1C and lipid profile were assessed through blood sampling.
|
Blood sample for Hb A1C and lipid profile, blood pressure and BMI
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose tolerance
Time Frame: July 2008- July 2013
|
Glucose tolerance was assessed by measuring the Hb A1C of the patients in both groups.
|
July 2008- July 2013
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Behzad Nemati Honar, professor, Imam Hosein General Hospital
- Principal Investigator: Sahar Saeedi, MD, Imam Hosein General Hospital
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
Other Study ID Numbers
- ImamHGH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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