Long Term Effect of Splenectomy on Metabolism

Completed

• Conditions: Trauma Splenic
• Interventions: Diagnostic Test: Blood sample

• Registration Number: NCT03648307
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2008-07
• Primary Completion: 2018-07
• Status Verified: 2018-08
• Study Completion: 2018-08
• Study First Submitted: 2018-08-18
• Study First Submitted QC: 2018-08-23
• Last Update Submitted: 2018-08-23
• Study First Posted: 2018-08-27
• Last Update Posted: 2018-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bowel resection	Blood sample	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.
Trauma splenectomized	Blood sample	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.

Primary Outcome Measures

Name	Time	Method
Glucose tolerance	July 2008- July 2013	Glucose tolerance was assessed by measuring the Hb A1C of the patients in both groups.