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

Area of Science:

• Surgical Innovation
• Clinical Trial Design
• Abdominal Surgery

Background:

• Limited randomized controlled trials exist comparing small to large fascial bite techniques.
• Standardization recommendations for small bite closures lack robust comparative data.
• Large-scale randomized controlled trials (RCTs) are resource-intensive and may benefit from pilot studies.

Purpose of the Study:

• To investigate the feasibility of a multi-center randomized controlled pilot study.
• To compare outcomes between small and large surgical closure techniques in median laparotomy incisions.
• To inform the design and resource allocation for a potential full-scale trial.

Main Methods:

• A multi-center randomized controlled pilot study was conducted.
• Adult patients undergoing median laparotomy incision were included.
• The study focused on assessing feasibility rather than hypothesis testing.

Main Results:

• Patient enrollment and completion rates were lower than planned.
• Adding a study coordinator significantly improved patient enrollment.
• The pilot study incurred costs of $19,152.50 over 22 months.

Conclusions:

• Planning a large-scale randomized trial on fascial bite techniques is complex.
• A full-scale study necessitates dedicated personnel and substantial grant funding.
• This pilot study provides crucial insights into the challenges of conducting large surgical RCTs.