Hydronephrosis After Anterior Lumbar Interbody Fusion (ALIF)

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.

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Key information

Conditions

Hydronephrosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen's Medical Centre

Nottingham, NG7 2UH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound

Radiation

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Nottingham University Hospitals NHS Trust

Other

Registry information

Acronym: HAALIF

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Nov 29, 2016
Registry last updated: Nov 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed