Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001194954
Ethics application status
Not yet submitted
Date submitted
14/11/2011
Date registered
18/11/2011
Date last updated
18/11/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Sleep and circadian rhythm disruption in patients undergoing laparoscopic donor nephrectomy
Scientific title
Sleep and circadian rhythm disruption in patients undergoing laparoscopic donor nephrectomy
Secondary ID [1] 273384 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep disturbance post kidney donation surgery. 279159 0
Disturbance in the circadian clock post kidney donation surgery. 279184 0
Condition category
Condition code
Other 279348 279348 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
Surgery 279383 279383 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational Study

6-sulphatoxymelatonin (aMT6s), a marker of the circadian clock, will be assayed in urine samples over 24 hours prior to surgery, on the first post operative day and after seven days at home. The alterations in the phase and amplitude of the melatonin profile will be investigated.

Actigraphic monitoring of sleep wake cycles and light levels will be conducted seven days prior to surgery, throughout the hospital stay and for four weeks post operatively.

Patients will be asked to complete sleep diaries and mood questionnaires throughout the study period to measure changes in sleep parameters (total sleep, sleep fragmentation and sleep timing) and changes in mood.
Intervention code [1] 283714 0
Not applicable
Comparator / control treatment
Baseline data will be collected from patients, hence they are essentially their own controls.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 285946 0
To investigate the effects of hospitalisation, anaesthesia and surgery resulting in significant post-operative sleep and circadian disruption in otherwise healthy fit kidney donor patients. These effects will be investigated via actigraphic monitoring of sleep wake cycles and light levels and 6-sulphatoxymelatonin (aMT6s), a marker of the circadian clock, will be assayed in urine samples.
Timepoint [1] 285946 0
At baseline (pre-operatively at home), on first post-operative day (in hospital) and 4 and 12 week follow ups (post-operatively at home).
Secondary outcome [1] 294825 0
To investigate the extent of mood reduction and fatigue in these patients correlates with the extent of post-operative sleep and circadian disruption. Patients will be asked to keep sleep diaries, pain assessment visual analogue scales and questionnaires on sleeping habits (Munich Chronotype Questionnaire and Horne-Ostberg Questionnaire) and a mood questionnaire (Beck Depression Scales).
Timepoint [1] 294825 0
At baseline (pre-operatively at home), on first post-operative day (in hospital) and 4 and 12 week follow ups (post-operatively at home).

Eligibility
Key inclusion criteria
Patients must:

be scheduled for laparoscopic donor nephrectomy surgery at Wellington Hospital.

provide written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients will be excluded if:
they do not meet the inclusion criteria.
they are already enrolled in another concurrent clinical trial.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/01/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 3948 0
New Zealand
State/province [1] 3948 0
Wellington

Funding & Sponsors
Funding source category [1] 284196 0
Hospital
Name [1] 284196 0
Wellington Hospital / Capital & Coast District Health Board
Country [1] 284196 0
New Zealand
Funding source category [2] 284197 0
University
Name [2] 284197 0
The University of Auckland.
Country [2] 284197 0
New Zealand
Primary sponsor type
Individual
Name
Dr Andrew Kennedy-Smith
Address
Private Bag 7902
Wellington South
6242
Country
New Zealand
Secondary sponsor category [1] 269157 0
Individual
Name [1] 269157 0
Dr Guy Warman
Address [1] 269157 0
Department of Anaesthesiology
University of Auckland
Private Bag 92019
Auckland 1142
Country [1] 269157 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286163 0
Ethics committee address [1] 286163 0
Ethics committee country [1] 286163 0
Date submitted for ethics approval [1] 286163 0
01/12/2011
Approval date [1] 286163 0
Ethics approval number [1] 286163 0

Summary
Brief summary
There is currently a shortage of kidneys for donation in New Zealand. Any measures that can improve the process of patients giving live donation of kidneys will help meet this shortage. Kidney donor patients pre-operatively are fit and well. Studies have shown that a laparoscopic (keyhole) approach to nephrectomy aids in a quick recovery. Despite this, in the follow up of these patients it appears that a fatigue factor may persist post surgery. This may be due to sleep disturbance from the operation, anaesthetic and hospital stay. Surgery and anaesthesia are known to cause sleep disturbances and fatigue, in part due to a disturbance in the circadian clock which controls sleep. In this study we will recruit 20 healthy patients scheduled to undergo laproscopic donor nephrectomy surgery and monitor sleep and activity (using actiwatches), circadian rhythms (using urine samples)and fatigue and mood (using questionnaires) at four separate time points both before and after surgery. Data from these patients will provide a clear understanding of the extent of sleep disruption and mood reduction which is attributable to hospitalisation and surgery. Subsequent follow up studies will include interventions to try and address any significant disruptions identified here in order to reduce the impact of kidney donation on the donors.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33386 0
Address 33386 0
Country 33386 0
Phone 33386 0
Fax 33386 0
Email 33386 0
Contact person for public queries
Name 16633 0
Kerry-Lee De Villiers
Address 16633 0
Department of Anaesthesiology
University of Auckland
Private Bag 92019
Auckland 1142
Country 16633 0
New Zealand
Phone 16633 0
+64 9 3737599 ext 89302
Fax 16633 0
+64 9 3737970
Email 16633 0
[email protected]
Contact person for scientific queries
Name 7561 0
Dr Andrew Kennedy-Smith
Address 7561 0
Urology Department
Wellington Hospital
Private Bag 7902
Wellington South
6242
Country 7561 0
New Zealand
Phone 7561 0
+64 4 3855999
Fax 7561 0
Email 7561 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.