Long Term Effect of Splenectomy on Metabolism

Trauma Splenic Clinical Trial

Official title:

Long-term Effect of Splenectomy on Metabolism, a Retrospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03648307
• Other study ID #: ImamHGH
• Status: Completed
• Start date: July 2008
• Est. completion date: August 2018

Study information

• Verified date: August 2018
• Source: Imam Hossein General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: August 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Trauma Splenic

Intervention

Diagnostic Test:
• Blood sample
Blood sample for Hb A1C and lipid profile, blood pressure and BMI

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Imam Hossein General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose tolerance	Glucose tolerance was assessed by measuring the Hb A1C of the patients in both groups.	July 2008- July 2013