HydronephrosisHAALIFNCT02976870
Hydronephrosis After Anterior Lumbar Interbody Fusion (ALIF)
A study testing Ultrasound in people with Hydronephrosis, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Anterior lumbar spinal surgery involves making an incision through the abdomen of the patient in order to access the spine. During this process, several internal structures are pushed aside in order to gain access. One of these structures is the ureter, whose function is to drain urine from the kidney to the bladder. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hydronephrosis
- What is being tested?
- Ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2012to Aug 2013
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years of age
- Has the mental capacity to provide informed consent for participation within the study
- Patients who have had anterior lumbar spinal surgery at least 12 months ago and no longer than 5 years ago
Who cannot join
- Unable to understand written or verbal information regarding the study
- Multiple abdominal surgeries prior to spinal surgery
- Previous renal complication such as renal strictures or hydronephrosis/use of stents
- Pregnancy
- Structural anomalies
Trial locations and contacts
1 site in 1 country.
About this study
Anterior lumbar spinal surgery involves making an incision through the abdomen of the patient in order to access the spine. During this process, several internal structures are pushed aside in order to gain access. One of these structures is the ureter, whose function is to drain urine from the kidney to the bladder. One potential complication that can arise from this is dilation of the kidney - known as hydronephrosis. The aim of this study is to identify whether hydronephrosis after Anterior Lumbar Interbody Fusion (ALIF) is complication, in order to bring this to the attention of health care professionals when considering this kind of surgery.
Read the detailed description
A total of 40 patients who have had ALIF surgery will be invited to have an ultrasound scan of their kidney on the side where the operation was performed (where the scar is). Should hydronephrosis of this kidney be detected, the investigators will go on to scan the second kidney. Should hydronephrosis be detected the patient will be given a letter to take to their General Practitioner (GP) advising them to be referred to a Urologist.
- Conditions
- Hydronephrosis
- Being tested
- Ultrasound
- Keywords
- Hydronephrosis, Anterior Lumbar Interbody Fusion
- Medical subject headings
- Hydronephrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundRadiation
Single ultrasound scan of kidney on side of body where ALIF was performed. If hydronephrosis of this kidney is detected, the second kidney will also be scanned.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Experimental | Single ultrasound scan of kidney on side of body where ALIF was performed. If hydronephrosis of this kidney is detected, the second kidney will also be scanned. Receives: Radiation: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of hydronephrosis on ultrasound scan
Each participant will have an ultrasound scan of their kidney. After this ultrasound scan participant will have no further involvement in the study.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startNov 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydronephrosisStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bronek Boszczyk, PD. Dr.med., Principal investigator, The Centre for Spinal Studies and Surgery, Queen's Medical Centre, Nottingham, NG7 2UH.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976870
- Sponsor's protocol ID
- 12SP006
- Acronym
- HAALIF
- Status last verified
- Nov 2016
- First submitted
- 5 Oct 2012
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydronephrosis After Anterior Lumbar Interbody Fusion (ALIF)
- ClinicalTrials.gov ID
- NCT02976870
- Acronym / sponsor ID
- HAALIF / 12SP006
- Conditions
- Hydronephrosis
- Keywords
- Hydronephrosis, Anterior Lumbar Interbody Fusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 29 Nov 2016 (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.
Anterior lumbar spinal surgery involves making an incision through the abdomen of the patient in order to access the spine. During this process, several internal structures are pushed aside in order to gain access. One of these structures is the ureter, whose function is to drain urine from the kidney to the bladder. One potential complication that can arise from this is dilation of the kidney - known as hydronephrosis. The aim of this study is to identify whether hydronephrosis after Anterior Lumbar Interbody Fusion (ALIF) is complication, in order to bring this to the attention of health care professionals when considering this kind of surgery.
Detailed description
A total of 40 patients who have had ALIF surgery will be invited to have an ultrasound scan of their kidney on the side where the operation was performed (where the scar is). Should hydronephrosis of this kidney be detected, the investigators will go on to scan the second kidney. Should hydronephrosis be detected the patient will be given a letter to take to their General Practitioner (GP) advising them to be referred to a Urologist.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Experimental | Radiation: UltrasoundSingle ultrasound scan of kidney on side of body where ALIF was performed. If hydronephrosis of this kidney is detected, the second kidney will also be scanned. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years of age
- Has the mental capacity to provide informed consent for participation within the study
- Patients who have had anterior lumbar spinal surgery at least 12 months ago and no longer than 5 years ago
Key exclusion criteria (5 listed)
- Unable to understand written or verbal information regarding the study
- Multiple abdominal surgeries prior to spinal surgery
- Previous renal complication such as renal strictures or hydronephrosis/use of stents
- Pregnancy
- Structural anomalies
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 |
|---|---|---|
| UltrasoundSingle ultrasound scan of kidney on side of body where ALIF was performed. If hydronephrosis of this kidney is detected, the second kidney will also be scanned. | Radiation | Ultrasound |
Primary outcome
Identification of hydronephrosis on ultrasound scan
Time frame: 12 month
Each participant will have an ultrasound scan of their kidney. After this ultrasound scan participant will have no further involvement in the study.
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 29 Nov 2016.
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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.
Bronek Boszczyk, PD. Dr.med. principal investigator
The Centre for Spinal Studies and Surgery, Queen's Medical Centre, Nottingham, NG7 2UH.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Hydronephrosis, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
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 3 inclusion and 5 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 29 Nov 2016. 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 United Kingdom. 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. 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?
Identification of hydronephrosis on ultrasound scan (time frame: 12 month). 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 29 Nov 2016.