Trauma SplenicNCT03648307
Long Term Effect of Splenectomy on Metabolism
An observational study of Trauma Splenic, run by Imam Hossein General Hospital.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Trauma Splenic
- What is being tested?
- Blood sample
- How many people
- 154 participants
- Where
- No sites listed yet
- Study dates
- Jul 2008to Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- trauma splenectomy or bowel resection due to obstruction between July 2008 and July 2013
Who cannot join
- 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
Show all 9Show fewer
- 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)
About this study
Official title: 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.
Read the 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:
- 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).
- Conditions
- Trauma Splenic
- Being tested
- Blood sample
- Keywords
- Splenectomy, metabolism, diabetes, stem cells, trauma surgery
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleDiagnostic test
Also called BMI and blood pressure measurement
Blood sample for Hb A1C and lipid profile, blood pressure and BMI
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Blood sample | |
| 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. Receives: Diagnostic Test: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose tolerance
Glucose tolerance was assessed by measuring the Hb A1C of the patients in both groups.
Measured: July 2008- July 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study startJul 2008
- Primary completionJul 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma SplenicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imam Hossein General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Parnian Jabbari, Imam Hossein General Hospital
- Investigators
- Behzad Nemati Honar, professor, Study director, Imam Hosein General HospitalSahar Saeedi, MD, Principal investigator, Imam Hosein General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648307
- Sponsor's protocol ID
- ImamHGH
- Status last verified
- Aug 2018
- First submitted
- 18 Aug 2018
- Last updated
- 27 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Details of patients identities and data obtained from measurements will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effect of Splenectomy on Metabolism, a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT03648307
- Acronym / sponsor ID
- ImamHGH
- Conditions
- Trauma Splenic
- Keywords
- Splenectomy, metabolism, diabetes, stem cells, trauma surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Imam Hossein General HospitalUniversity, hospital or other
- Study start
- Jul 2008 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 27 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trauma splenectomized | – | Diagnostic Test: Blood samplePatients 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. |
| Bowel resection | – | Diagnostic Test: Blood samplePatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- trauma splenectomy or bowel resection due to obstruction between July 2008 and July 2013
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleAlso: BMI and blood pressure measurementBlood sample for Hb A1C and lipid profile, blood pressure and BMI | Diagnostic test | Bowel resection, Trauma splenectomized |
Primary outcome
Glucose tolerance
Time frame: July 2008- July 2013
Glucose tolerance was assessed by measuring the Hb A1C of the patients in both groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
- Individual participant dataSharing planned: No. Details of patients identities and data obtained from measurements will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Behzad Nemati Honar, professor study director
Imam Hosein General Hospital
Sahar Saeedi, MD principal investigator
Imam Hosein General Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma Splenic, run by Imam Hossein General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose tolerance (time frame: July 2008- July 2013). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2018.