Clinical trial NCT03648307: Long Term Effect of Splenectomy on Metabolism
Official title: Long-term Effect of Splenectomy on Metabolism, a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma Splenic
Keywords: Splenectomy
metabolism
diabetes
stem cells
trauma surgery
Lead sponsor: Imam Hossein General Hospital
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 154
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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).

Eligibility 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)

Primary outcomes:
measure: Glucose tolerance
timeFrame: July 2008- July 2013
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Imam Hosein General Hospital
name: Behzad Nemati Honar, professor
role: STUDY_DIRECTOR
affiliation: Imam Hosein General Hospital
name: Sahar Saeedi, MD
role: PRINCIPAL_INVESTIGATOR
References: