Hydronephrosis After Anterior Lumbar Interbody Fusion (ALIF)

Not Applicable

Completed

• Conditions: Hydronephrosis
• Interventions: Radiation: Ultrasound

• Registration Number: NCT02976870
• Lead Sponsor: Nottingham University Hospitals NHS Trust

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.

Study Timeline

• Study First Submitted: 2012-10-05
• Study Start: 2012-11
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2016-11
• Study First Submitted QC: 2016-11-28
• Last Update Submitted: 2016-11-28
• Study First Posted: 2016-11-29
• Last Update Posted: 2016-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultrasound	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.

Primary Outcome Measures

Name	Time	Method
Identification of hydronephrosis on ultrasound scan	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.

Trial Locations

Locations (1)

Queen's Medical Centre; 🇬🇧 Nottingham, United Kingdom