ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12608000430336

Ethics application status

Approved

Date submitted

22/06/2008

Date registered

29/08/2008

Date last updated

29/08/2008

Type of registration

Retrospectively registered

Titles & IDs

Public title

ACRP Study (Anterior Cervical Retraction Pressure Study)

Scientific title

A comparison of intra-operative retraction pressure during anterior cervical surgery between a novel retractor system and conventional retractor system – a pilot study.

Secondary ID [1]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

voice change

dysphagia

sore throat

Condition category

Condition code

Surgery

Other surgery

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

In this study the recruited candidates are prospectively randomized into two groups. In one group Casper retraction system will be used and in the other group Seex's retraction system will be used for anterior cervical surgical procedures. For each patients one procedure will be done with one retractor system. In all the patients an online pressure transducer (Tekscan pressure measurement system) will be applied to the rear side of the medial retractor blade on to the food pipe and pressure changes will be recorded electronically throughout the period of retraction.
The retractor system randomized for a particular patient will be used through out the period of retraction which is needed to complete the proposed procedure. Retraction period may vary between patients
proposed period of study is 18 months.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

The group with conventional retractor system

Control group

Active

Outcomes

Primary outcome [1]

The retraction pressure on wind pipe and food pipe in patients under going neck operations using the conventional Casper retraction system and Seex retractor system.

Timepoint [1]

Continuously throughout the period of retraction

Secondary outcome [1]

A self-assessment of sore throat, difficulty in swallowing and voice change by the participants using a chart of rating score.

Timepoint [1]

24 hrs, 1 week and 4weeks after operation

Eligibility

Key inclusion criteria

All the patients scheduled for spinal operations from the front of the neck in Nepean hospital, Kingswood, NSW

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

previous neck operations, radiation to the neck or those with history of tumors

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Randomization information is kept in serially numbered sealed opaque envelopes. Those envelopes are kept in the office of the Head of neurosurgery Nepean hospital. The recruited candidates are serially numbered as per the order in which they are coming to theater for operation. This serial number will be used for randomization purpose. Operation theater staff contacts the office of the Head of neurosurgery and finds out which retractor system is randomized for the serial number

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomization by using a randomization table created by an online computer program (www.graphpad.com/quickcalcs/randomN1.cfm)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/07/2007

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Ananthababu Pattavilakom

Address [1]

Dept of Neurosurgery, Nepean Hospital
Derby st
Kingswood
NSW 2751

Country [1]

Australia

Primary sponsor type

Hospital

Name

Nepean Hospital

Address

Derby st
Kingswood
NSW 2751

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Sydney West Area Health Service HREC, Nepean Campus

Ethics committee address [1]

Nepean Campus
Derby st
Kingswood
NSW 2751

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

25/06/2007

Ethics approval number [1]

HREC Project No. 07/007:

Summary

Brief summary

Operations of the spine, when performed from the front of the neck can cause problems like sore throat, difficulty in swallowing and voice change during postoperative period. Often these problems are temporary, but they are common. Most of the patients feel these symptoms are very uncomfortable. These symptoms are attributed to the retraction of structures like wind pipe and food pipe during the operation. The retraction causes pressure on to these structures and results in direct damage as well as damage due to reduced blood flow during the period of retraction. The more the pressure the more will be the damage and the worse will be the symptoms. Conventional retractor systems are designed to mount directly on to the soft tissues during the operation, causing direct transmission of retraction pressure on to them. A novel retractor system (Seex retractor system) has been introduced in to surgical practice. The new system is mounted/fixed directly on to the bones (vertebrae) during the procedure so that the amount of direct pressure transmission to wind pipe or food pipe is theoretically much less than the conventional retractors. Cadaver studies conducted by the researchers agree with that. In this pilot study the researchers prospectively measure the pressure variations on windpipe and food pipe in the two groups of patients under going neck operations with conventional retraction system and the new system. They will also assess sore throat, difficulty in swallowing and voice change in patients of both the groups during postoperative period using rating score chart. Data collected in this unblinded pilot study will be used to design a subsequent randomized controlled trial, if the new system appears to be a better one.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Ananthababu Pattavilakom

Address

Dept of Neurosurgery, Nepean Hospital
Derby st
Kingswood
NSW 2751

Country

Australia

Phone

(02) 47342000

Fax

[email protected]

Contact person for scientific queries

Name

Ananthababu Pattavilakom

Address

Dept of Neurosurgery, Nepean Hospital
Derby st
Kingswood
NSW 2751

Country

Australia

Phone

(02) 47342000

Fax

[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

Source	Title	Year of Publication	DOI
Embase	Results of a prospective randomized study comparing a novel retractor with a caspar retractor in anterior cervical surgery.	2011	https://dx.doi.org/10.1227/NEU.0b013e318219565f

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically