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.
Nepean Hospital
20 participants
Jul 1, 2007
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
Plain Language Summary
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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 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)
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ACTRN12608000430336