Evaluating an optimal gastric closure method for transgastric surgery

Abstract

Background: The transgastric approach is currently being studied as a potentially less invasive alternative to conventional laparoscopy for intra-abdominal surgery. A major obstacle to overcome is the closure of the transgastric incision in a rapid, reproducible, and safe manner. The effectiveness of various techniques for gastrotomy closure were compared by assessing leak pressures in an ex vivo porcine stomach model.

Methods: Whole stomachs from adult white pigs were suspended in a Plexiglas box to facilitate endoscopic technique. Standard gastrotomies were made by needle knife incision and dilation with a controlled radial expansion (CRE) balloon. The first arm used standard QuickClips; the second, a prototype device developed by LSI Solutions; the third, hand-sewn by a senior surgeon; the final, a control with open gastrotomy. Five stomachs were tested per study arm. After closure, each stomach was inflated by an automated pressure gauge. The pressures to achieve air leakage and liquid leakage were recorded.

Results: The unclosed controls demonstrated air leakage at a median pressure of 15 mmHg, representing baseline system resistance. The QuickClip closures leaked air at a median pressure of 33 mmHg. The prototype gastrotomy device yielded the highest median air leak pressure of 85 mmHg while dramatically diminishing time for incision and gastrotomy closure to approximately 5 min. The hand-sewn closures leaked air at a median pressure of 47 mmHg. Using Kruskal-Wallis statistical analysis, the comparisons were significant (p = 0.0019). Post hoc paired comparisons using MULTTEST procedure with both Bonferroni and bootstrap adjustments revealed that the difference between prototype and clips was significant; prototype versus hand-sewn was not. Liquid-leak pressures produced similar results.

Conclusions: The prototype device decreases procedure time and yields leak-resistant gastrotomy closures that are superior to clips and rival hand-sewn interrupted stitches.