Hydronephrosis After Anterior Lumbar Interbody Fusion (ALIF) (HAALIF)
Primary Purpose
Hydronephrosis
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Hydronephrosis focused on measuring Hydronephrosis, Anterior Lumbar Interbody Fusion
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Queen's Medical Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ultrasound
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02976870
First Posted
October 5, 2012
Last Updated
November 28, 2016
Sponsor
Nottingham University Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT02976870
Brief Title
Hydronephrosis After Anterior Lumbar Interbody Fusion (ALIF)
Acronym
HAALIF
Official Title
Hydronephrosis After Anterior Lumbar Interbody Fusion (ALIF)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nottingham University Hospitals NHS Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hydronephrosis
Keywords
Hydronephrosis, Anterior Lumbar Interbody Fusion
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Ultrasound
Intervention Description
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.
Primary Outcome Measure Information:
Title
Identification of hydronephrosis on ultrasound scan
Description
Each participant will have an ultrasound scan of their kidney. After this ultrasound scan participant will have no further involvement in the study.
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bronek Boszczyk, PD. Dr.med.
Organizational Affiliation
The Centre for Spinal Studies and Surgery, Queen's Medical Centre, Nottingham, NG7 2UH.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen's Medical Centre
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Hydronephrosis After Anterior Lumbar Interbody Fusion (ALIF)
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