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Long Term Effect of Splenectomy on Metabolism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03648307
Recruitment Status : Completed
First Posted : August 27, 2018
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Parnian Jabbari, Imam Hossein General Hospital

Brief Summary:
Metabolic status of patients who had gone through trauma splenectomy between July 2008 and July 2013 were compared to patients who had gone through bowel resection due to obstruction in the same period of time. all patients were followed up for 5-10 years.

Condition or disease Intervention/treatment
Trauma Splenic Diagnostic Test: Blood sample

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).

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Study Type : Observational
Actual Enrollment : 154 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Long-term Effect of Splenectomy on Metabolism, a Retrospective Cohort Study
Actual Study Start Date : July 2008
Actual Primary Completion Date : July 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


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.
Diagnostic Test: Blood sample
Blood sample for Hb A1C and lipid profile, blood pressure and BMI
Other Name: BMI and blood pressure measurement

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.
Diagnostic Test: Blood sample
Blood sample for Hb A1C and lipid profile, blood pressure and BMI
Other Name: BMI and blood pressure measurement




Primary Outcome Measures :
  1. Glucose tolerance [ Time Frame: July 2008- July 2013 ]
    Glucose tolerance was assessed by measuring the Hb A1C of the patients in both groups.


Biospecimen Retention:   Samples Without DNA
Blood samples for lipid profile and Hb A1C


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who had gone through bowel resection due to obstruction or trauma splenectomy in Imam Hosein General Hospital between July 2008 and July 2013
Criteria

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)

Information from the National Library of Medicine

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): NCT03648307


Sponsors and Collaborators
Imam Hossein General Hospital
Investigators
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Study Director: Behzad Nemati Honar, professor Imam Hosein General Hospital
Principal Investigator: Sahar Saeedi, MD Imam Hosein General Hospital
  Study Documents (Full-Text)

Documents provided by Parnian Jabbari, Imam Hossein General Hospital:
Study Protocol  [PDF] August 21, 2018


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Responsible Party: Parnian Jabbari, Researcher at Imam Hossein General Hospital, Medical Doctor, Imam Hossein General Hospital
ClinicalTrials.gov Identifier: NCT03648307    
Other Study ID Numbers: ImamHGH
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Details of patients identities and data obtained from measurements will not be shared with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Parnian Jabbari, Imam Hossein General Hospital:
Splenectomy
metabolism
diabetes
stem cells
trauma surgery