Long Term Effect of Splenectomy on Metabolism

August 23, 2018 updated by: Parnian Jabbari, Imam Hossein General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

154

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • 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.
Blood sample for Hb A1C and lipid profile, blood pressure and BMI
Other Names:
  • BMI and blood pressure measurement

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Behzad Nemati Honar, professor, Imam Hosein General Hospital
  • Principal Investigator: Sahar Saeedi, MD, Imam Hosein General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2008

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

August 18, 2018

First Submitted That Met QC Criteria

August 23, 2018

First Posted (Actual)

August 27, 2018

Study Record Updates

Last Update Posted (Actual)

August 27, 2018

Last Update Submitted That Met QC Criteria

August 23, 2018

Last Verified

August 1, 2018

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)?

NO

IPD Plan Description

Details of patients identities and data obtained from measurements will not be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Trauma Splenic

Clinical Trials on Blood sample

3
Subscribe