RecruitingACTRN12608000430336

ACRP Study (Anterior Cervical Retraction Pressure Study)

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


Sponsor

Nepean Hospital

Enrollment

20 participants

Start Date

Jul 1, 2007

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is about a new type of surgical tool used during neck spine operations. When surgeons operate on the spine through the front of the neck, they need to move aside the windpipe and food pipe to reach the spine. This can sometimes cause a sore throat, trouble swallowing, or voice changes after surgery. A new retractor (a tool that holds tissue out of the way) attaches to the bones instead of the soft tissues, which may cause less pressure and fewer side effects. This pilot study measures the actual pressure on the windpipe and food pipe during surgery with the old and new tools, and tracks post-surgery symptoms. You may be eligible if: - You are scheduled for a spine operation through the front of the neck at Nepean Hospital in Kingswood, NSW - You are 18 years of age or older You may NOT be eligible if: - You have had a previous neck operation - You have had radiation treatment to the neck - You have a history of neck tumors Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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.


Locations(1)

Australia

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ACTRN12608000430336