Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000081617
Ethics application status
Approved
Date submitted
31/07/2005
Date registered
5/08/2005
Date last updated
5/04/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
HATS trial
Scientific title
Hand-assisted thoracoscopic surgery versus Limited thoracotomy: Randomised controlled trial comparing early post-operative quality of life after diagnostic lung biopsy and radical metastasectomy
Secondary ID [1] 291626 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
HATS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
1. Undiagnosed pulmonary nodules not accessible by VATS.
 158 0
2. Pulmonary metastases suitable for wedge resection. 159 0
Condition category
Condition code
Cancer 177 177 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Access to the lung using thoracoscope and trans-diaphragmatic palpation via small subcostal incision. Compared with smallest practical thoracotomy incision to acheive same lung resection.
Intervention code [1] 79 0
Treatment: Surgery
Comparator / control treatment
Limited thoracotomy
Control group
Active

Outcomes
Primary outcome [1] 214 0
Quality of life scores (SF-12v2)
Timepoint [1] 214 0
14 and 42 days post surgery
Secondary outcome [1] 490 0
Pain scores
Timepoint [1] 490 0
In 24 hours after epidural removal.
Secondary outcome [2] 491 0
Ipsilateral lung recurrence of pulmonary metastases.
Timepoint [2] 491 0
2 years
Secondary outcome [3] 492 0
Respiratory function.
Timepoint [3] 492 0
6 months
Secondary outcome [4] 493 0
Diaphragm function.
Timepoint [4] 493 0
6 months
Secondary outcome [5] 494 0
Wound complications.
Timepoint [5] 494 0
30 days

Eligibility
Key inclusion criteria
Consenting adult requiring either diagnosis of lung nodule or clearance of pulmonary metastases from sarcoma, colorectal or renal carcinoma, melanoma or germ cell tumour. Must be amenable to wedge resection. Must have PET scan to exclude extra-thoracic disease and confirm primary site control.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Independently held codes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated. Stratified for indication.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2001
Actual
23/10/2001
Date of last participant enrolment
Anticipated
Actual
4/05/2005
Date of last data collection
Anticipated
Actual
3/05/2010
Sample size
Target
60
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 233 0
University
Name [1] 233 0
University grant
Country [1] 233 0
Australia
Primary sponsor type
Individual
Name
Gavin M Wright
Address
Cardiothoracic Research Office
St Vincent's Hospital
41 Victoria Parade
Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 173 0
Individual
Name [1] 173 0
Joseph M Paiva
Address [1] 173 0
Cardiothoracic Research Office
St Vincent's Hospital
41 Victoria Parade
Fitzroy VIC 3065
Country [1] 173 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1031 0
St Vincent's Hospital, Melbourne
Ethics committee address [1] 1031 0
Ethics committee country [1] 1031 0
Australia
Date submitted for ethics approval [1] 1031 0
Approval date [1] 1031 0
01/10/2001
Ethics approval number [1] 1031 0
Ethics committee name [2] 1032 0
St Vincent's and Mercy Private Hospital
Ethics committee address [2] 1032 0
Ethics committee country [2] 1032 0
Australia
Date submitted for ethics approval [2] 1032 0
Approval date [2] 1032 0
Ethics approval number [2] 1032 0

Summary
Brief summary
To determine whether a new form of minimally invasive ("keyhole") surgery results in less pain and suffering than traditional surgery of the lung via thoracotomy.
Trial website
Trial related presentations / publications
1. Paiva JM, Wright GM. Hand assisted thoracoscopic surgery causes less postoperative pain than limited thoracotomy after cessation of epidural analgesia. Heart Lung Circ 2004; 13: 374-8.
2. Wright GM, Clarke CP, Paiva J. How to do it: Hand Assisted Thoracoscopic Surgery. Ann Thorac Surg 2003; 75: 1665-7.
3. Wright GM, Long H, Hand-assist VATS: minimum invasion, maximum return, ANZ J Surg 2001; 71 (s1): A17
4. Dear RF, Kelly PJ, Wright GM, Stalley P, McCaughan BC, Tattersall MHN. Pulmonary metastasectomy for bone and soft tissue sarcoma in Australia: 114 patients from 1978 to 2008. Asia Pac J Clin Oncol 2012; 10.1111/j.1743-7563.2012.01521.x
Public notes

Contacts
Principal investigator
Name 35815 0
A/Prof Gavin M Wright
Address 35815 0
Cardiothoracic Research Office
St Vincent's Hospital
41 Victoria Parade
Fitzroy VIC 3065
Country 35815 0
Australia
Phone 35815 0
+61 3 9419 2477
Fax 35815 0
Email 35815 0
Gavin.Wright@svha.org.au
Contact person for public queries
Name 9268 0
Gavin M Wright
Address 9268 0
St Vincents's Hospital Melbourne
5th Floor
55 Victoria Parade
Fitzroy VIC 3065
Country 9268 0
Australia
Phone 9268 0
+61 3 94192477
Fax 9268 0
+61 3 94171694
Email 9268 0
gavin.wright@svha.org.au
Contact person for scientific queries
Name 196 0
Gavin M Wright
Address 196 0
St Vincents's Hospital Melbourne
5th Floor
55 Victoria Parade
Fitzroy VIC 3065
Country 196 0
Australia
Phone 196 0
+61 3 94192477
Fax 196 0
+61 3 94171694
Email 196 0
gavin.wright@svha.org.au

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
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Documents added automatically
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