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CompletedNCT02976870HAALIFUpdated Nov 29, 2016

Hydronephrosis After Anterior Lumbar Interbody Fusion (ALIF)

An interventional study of Ultrasound in Hydronephrosis, sponsored by Nottingham University Hospitals NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-29.

Sponsored by Nottingham University Hospitals NHS Trust · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
39
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Hydronephrosis

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Keywords

  • Hydronephrosis
  • Anterior Lumbar Interbody Fusion
03

In context

Hydronephrosis

55 studies on the registry are indexed under Hydronephrosis; 9 are open to participants now.

This study's enrollment of 39 is below the median of 100 across 23 interventional studies indexed under Hydronephrosis.

Browse Hydronephrosis studies →

Lead sponsor

Nottingham University Hospitals NHS Trust is the lead sponsor of 107 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Over 18 years of age
  • Has the mental capacity to provide 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
39 participants (actual)

Study arms

  • Experimental
    Ultrasound

    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.

    Radiation: Ultrasound

Interventions

  • RadiationUltrasound

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 month

07

Study locations

1 site
  • Queen's Medical Centre
    Nottingham, NG7 2UH, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02976870
Responsible party
Sponsor
First posted
Nov 29, 2016
Start date
Nov 2012
Primary completion
Aug 2013
Completion
Aug 2013
Last update
Nov 29, 2016

Study contacts

Bronek Boszczyk, PD. Dr.med.
principal investigator · The Centre for Spinal Studies and Surgery, Queen's Medical Centre, Nottingham, NG7 2UH.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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