SurgeryPhase 1/2NCT02493894
The Effect of Bowel Preparation on Perioperative Bleeding
A Phase 1/2 study testing PEG and Cefazolin in people with Surgery, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
Now a days, due to the change in lifestyle, the extended lifespan and the increase in the rate of the road accidents, the need for surgical operation of spinal instrumentation has been increased. And these surgeries are the most crucial part of neurological surgery wards. Read more about this study
- Who is it for?
- Ages 33 to 82 years
- Conditions the study is for
- Surgery
- What is being tested?
- PEG and Cefazolin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteIran
- Study dates
- Jul 2014to Jun 2015
- Phase
- Phase 1/2
- 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 33 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who suffer from lumbar spine degenerative disease and need spine fusion surgery.
Who cannot join
- History of Trauma,
- History of Malignancy,
- previous spinal surgery,
- History of coagulation disorder,
- active infectious disease,
- gastrointestinal problems,
- severe movement disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: By Reza Abbasi and Isfahan University of Medical Sciences
Now a days, due to the change in lifestyle, the extended lifespan and the increase in the rate of the road accidents, the need for surgical operation of spinal instrumentation has been increased. And these surgeries are the most crucial part of neurological surgery wards. The everyday improvements in the quality of equipment used and advancements in surgical methods lead to best performance of these procedures and finally the higher quality of patients' lives. The procedures of Laminectomy and pedicular screw instrumentation lead to pain relief and better performance and developments in the quality of patients' lives.
In addition to the above mentioned improvements, you must consider the fact that these activities are still accompanied by complications during and after surgical operation.
Read more
Nerve root injury, Thecal sac tearing, injury to the spinal cord and the inappropriate sagittal balance are the most significant side effects during spinal surgery.
One of the most important complications during and after these surgeries is perioperative bleeding that causes problems both for the patients and the surgeon.
Read the detailed description
The individuals evaluated in this study were those who have been admitted and undergone spiral surgery (Fusion and Instrumentation) with pedicular screw because of spinal column instability and canal stenosis.
This study has been started and performed since Feb.2013 to June 2015 at the neurosurgery ward of Al.zahra hospital of Isfahan.
The candidates chosen for the study were those who undergone the surgery procedure due to degenerative change of Lumbar spinal canal.
The necessity of operation for each patient is diagnosed based on clinical finding, Imaging data and guidelines according to neurosurgery reference sources.(Richards Winn,Youmans Neurological Survey, Sixth Edition, Vol 3,Ch.303) During this prospective study, patients are randomly divided into two groups of Case and Control. The individuals attended these two groups are matched regarding age, sex and general medical condition. The age ranges in this study are 33 to 82 years old.
Other than general surgery consent taken from both groups, patients in Case group are informed about the procedure of the program and probable side effects.
Primarily, patients' weight, height, BMI, and Hemoglobin are recorded. In Case group, patients firstly get liquid diet for 24 hours. After that they get PEG solution (80gr/1Litr) each 8 hours for 24 hours. After 48 hours, bowel is mechanically prepared for the procedure. Cefazolin 1 gram every 6hours for 2 days was taken in both groups.
In both Case and Control groups, the time of surgery and the volume of bleeding (in CC) are precisely recorded by surgery and anesthesiology team. The need for blood transfusion during surgery is based on preoperation hemoglobin and the volume of bleeding during surgery and is calculated according to anesthesiology and surgical standards using the following formula:
( )/Hb ×0.6 BW kg×10022 Immediately at the end of surgery, the exact rate of bleeding during operation ( in CC), the length of operation and the length of the operation and the estimated transfusion rate are recorded.
Also, after surgery the volume of bleeding in homovac drain in time intervals of 24 to 48-hour are recorded.
Also the patients' levels of Hb in 24 to 48-hour intervals are calculated. After improving general medical conditions of the patients and their walking abilities, they are ambulated and finally are discharged from hospital.
- Conditions
- Surgery
- Being tested
- PEG, placebo, Cefazolin
- Keywords
- Bowel preparation, perioperative bleeding, lumbar fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEGDrug
Also called PEG solution
PEG solution (80gr/1Litr) each 8 hours for 24 hours
placeboDrug
Also called sham
placebo each 8 hours for 24 hours
CefazolinDrug
Also called Kefzol
cefazolin 1gram, every 6hours for 2 days
| Study group | Role | What they receive |
|---|---|---|
| PEG & Cefazolin | Experimental | patients firstly get liquid diet for 24 hours. After that they get PEG solution (80gr/1Litr) each 8 hours for 24 hours. After 48 hours, cefazolin 1gram, every 6hours for 2 days Receives: Drug: PEG; Drug: Cefazolin |
| placebo & cefazolin | Sham comparator | placebo for PEG and cefazolin 1gram, every 6hours for 2 days Receives: Drug: placebo; Drug: Cefazolin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The volume of bleeding was measured in milliliter
Measured: up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startJul 2014
- Primary completionMay 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abbasi, Isfahan University of Medical Sciences
- Investigators
- Reza Abbasi, MD, Principal investigator, Alzahra University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493894
- Sponsor's protocol ID
- Abbasi1
- Status last verified
- Jul 2015
- First submitted
- 18 Jun 2015
- Last updated
- 10 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhang F, Wang K, Li FN, Huang X, Li Q, Chen Z, Tang YB, Shen HX, Song QX. Effectiveness of tranexamic acid in reducing blood loss in spinal surgery: a meta-analysis. BMC Musculoskelet Disord. 2014 Dec 22;15:448. doi: 10.1186/1471-2474-15-448.
PubMed 25532706
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- By Reza Abbasi and Isfahan University of Medical Sciences
- ClinicalTrials.gov ID
- NCT02493894
- Acronym / sponsor ID
- Abbasi1
- Conditions
- Surgery
- Keywords
- Bowel preparation, perioperative bleeding, lumbar fusion
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 10 Jul 2015 (estimated)
- 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.
Now a days, due to the change in lifestyle, the extended lifespan and the increase in the rate of the road accidents, the need for surgical operation of spinal instrumentation has been increased. And these surgeries are the most crucial part of neurological surgery wards. The everyday improvements in the quality of equipment used and advancements in surgical methods lead to best performance of these procedures and finally the higher quality of patients' lives. The procedures of Laminectomy and pedicular screw instrumentation lead to pain relief and better performance and developments in the quality of patients' lives.
In addition to the above mentioned improvements, you must consider the fact that these activities are still accompanied by complications during and after surgical operation.
Nerve root injury, Thecal sac tearing, injury to the spinal cord and the inappropriate sagittal balance are the most significant side effects during spinal surgery.
One of the most important complications during and after these surgeries is perioperative bleeding that causes problems both for the patients and the surgeon.
Detailed description
The individuals evaluated in this study were those who have been admitted and undergone spiral surgery (Fusion and Instrumentation) with pedicular screw because of spinal column instability and canal stenosis.
This study has been started and performed since Feb.2013 to June 2015 at the neurosurgery ward of Al.zahra hospital of Isfahan.
The candidates chosen for the study were those who undergone the surgery procedure due to degenerative change of Lumbar spinal canal.
The necessity of operation for each patient is diagnosed based on clinical finding, Imaging data and guidelines according to neurosurgery reference sources.(Richards Winn,Youmans Neurological Survey, Sixth Edition, Vol 3,Ch.303) During this prospective study, patients are randomly divided into two groups of Case and Control. The individuals attended these two groups are matched regarding age, sex and general medical condition. The age ranges in this study are 33 to 82 years old.
Other than general surgery consent taken from both groups, patients in Case group are informed about the procedure of the program and probable side effects.
Primarily, patients' weight, height, BMI, and Hemoglobin are recorded. In Case group, patients firstly get liquid diet for 24 hours. After that they get PEG solution (80gr/1Litr) each 8 hours for 24 hours. After 48 hours, bowel is mechanically prepared for the procedure. Cefazolin 1 gram every 6hours for 2 days was taken in both groups.
In both Case and Control groups, the time of surgery and the volume of bleeding (in CC) are precisely recorded by surgery and anesthesiology team. The need for blood transfusion during surgery is based on preoperation hemoglobin and the volume of bleeding during surgery and is calculated according to anesthesiology and surgical standards using the following formula:
( )/Hb ×0.6 BW kg×10022 Immediately at the end of surgery, the exact rate of bleeding during operation ( in CC), the length of operation and the length of the operation and the estimated transfusion rate are recorded.
Also, after surgery the volume of bleeding in homovac drain in time intervals of 24 to 48-hour are recorded.
Also the patients' levels of Hb in 24 to 48-hour intervals are calculated. After improving general medical conditions of the patients and their walking abilities, they are ambulated and finally are discharged from hospital.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG & Cefazolin | Experimental | Drug: PEG, Drug: Cefazolinpatients firstly get liquid diet for 24 hours. After that they get PEG solution (80gr/1Litr) each 8 hours for 24 hours. After 48 hours, cefazolin 1gram, every 6hours for 2 days |
| placebo & cefazolin | Sham comparator | Drug: placebo, Drug: Cefazolinplacebo for PEG and cefazolin 1gram, every 6hours for 2 days |
Who may qualify
- Ages
- 33 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who suffer from lumbar spine degenerative disease and need spine fusion surgery.
Key exclusion criteria (7 listed)
- History of Trauma,
- History of Malignancy,
- previous spinal surgery,
- History of coagulation disorder,
- active infectious disease,
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 |
|---|---|---|
| PEGAlso: PEG solutionPEG solution (80gr/1Litr) each 8 hours for 24 hours | Drug | PEG & Cefazolin |
| placeboAlso: shamplacebo each 8 hours for 24 hours | Drug | placebo & cefazolin |
| CefazolinAlso: Kefzolcefazolin 1gram, every 6hours for 2 days | Drug | PEG & Cefazolin, placebo & cefazolin |
Primary outcome
The volume of bleeding was measured in milliliter
Time frame: up to 3 days
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 10 Jul 2015.
- Results publication: PubMed 25532706Zhang F, Wang K, Li FN, Huang X, Li Q, Chen Z, Tang YB, Shen HX, Song QX. Effectiveness of tranexamic acid in reducing blood loss in spinal surgery: a meta-analysis. BMC Musculoskelet Disord. 2014 Dec 22;15:448. doi: 10.1186/1471-2474-15-448.
- http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4326491/Link provided by the sponsor.
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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.
Reza Abbasi, MD principal investigator
Alzahra University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PEG and Cefazolin in people with Surgery, run by Isfahan University of Medical Sciences at 1 site in Iran.
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 7 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 10 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The volume of bleeding was measured in milliliter (time frame: up to 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02493894, which also lists 1 linked publication.
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 10 Jul 2015.