A Pilot and Feasibility Study to Evaluate Small and Large Bite Fascial Closure Techniques.

Introduction: Few randomized controlled studies have been conducted comparing a small to large fascial bite technique, yet recommendations have been made to standardize small bite closures. However, large scale randomized controlled trials require considerable effort and may benefit from a pilot study.

Methods: This multi-center randomized controlled pilot study of adult patients undergoing median laparotomy incision investigated the feasibility of studying the outcomes between small and large surgical closure techniques.

Results: Fifty of 100 planned patients consented, 32 patients completed surgery, and 19 patients completed the one-year ultrasound. Enrollment was 2.7 versus 8 patients per month pre/post addition of a study coordinator. Clinical results are summarized for feasibility demonstration purposes, but not analyzed for hypothesis testing. The total cost of the pilot study was $19,152.50 and took 22 months from first surgery to final one-year ultrasound.

Conclusions: This feasibility assessment demonstrated the complexity of planning a large-scale randomized trial evaluating small and large bite surgical closure technique. To expand this pilot study to a full scaled sample size study would require dedicated personnel and large grant funding.