Hydronephrosis After Anterior Lumbar Interbody Fusion (ALIF)

Hydronephrosis Clinical Trial

— HAALIF  

Official title:

Hydronephrosis After Anterior Lumbar Interbody Fusion (ALIF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02976870
• Other study ID #: 12SP006
• Status: Completed
• Phase: N/A
• First received: October 5, 2012
• Last updated: November 28, 2016
• Start date: November 2012
• Est. completion date: August 2013

Study information

• Verified date: November 2016
• Source: Nottingham University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hydronephrosis

Intervention

Radiation:
• 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.

Locations

Country	Name	City	State
United Kingdom	Queen's Medical Centre	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Nottingham University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 month	No