Comparison of pressure resistance of double-rows and triple-rows circular stapler in rectal double stapling technique: In vitro study

Abstract

Background: Anastomotic leak after gastrointestinal anastomosis is a serious complication. Anastomotic failure depends on various parameters. The aim of our study was to evaluate the pressure resistance of a new device, EEA™ circular stapler with Tri-Staple™ technology 28 mm Medium/Thick (Triple-rows circular stapler; TCS) compared with EEA™ circular stapler with DST series™ technology 28 mm, 4.8 mm staples (double-rows circular stapler; DCS). Patients and methods: We performed 30 anastomoses (DSC: 15, TCS: 15) of DST with porcine colon model in vitro. We performed following 3 comparative experiences; Experiment 1: observation of staple shape with a colonoscopy, Experiment 2: comparison of the pressure resistance, Experiment 3: comparison of leakage points. Results: There was no hypoplasia of staples and the shapes were well-formed by colonoscopy. The leakage pressure of DCS was 19.6 ± 4.4 mm Hg (mean ± standard deviation) and that of TCS was 38.6 ± 10.2 mm Hg (mean ± standard deviation). There was a significantly difference between 2 groups (P < .001). 12 cases of DCS (80%) and 10 cases of TCS (66.7%) had leakages from Circular stapler point. 2 cases of DCS (13.3%) and 5 cases of TCS (33.3%) had leakages from Crossing points. Only 1 case of DCS had leakages from Dog ear point (6.7%). There was no significantly difference in leakage site between 2 groups (P = .195). Conclusions: TSC showed high pressure resistance during DST compared with that of DCS. It was suggested that TCS may contribute to the reduction of anastomotic leakage rate.

Evaluating Performance of Circular Staplers Using Comparative Test Methods for Evidence-Based Surgery

“…13,14 Clinical results correlate intraoperative and postoperative leaks such as recent meta-analysis that reported a significantly higher rate of postoperative anastomotic leak among patients with a positive intraoperative air leak test (ie, leak observed upon inflation). 15 Other studies report comparative differences in burst pressure between manufacturers in preclinical settings and parallel clinical investigations, with triple-row staplers having statistically higher burst pressures in ex vivo porcine tissue and lower postoperative leak rates than double-row staplers [10][11][12] ; these results support the contention that higher leak pressures in animals accurately models risk against postoperative anastomotic leak in patients. Nevertheless, gross measurement of this pressure may not provide the required sensitivity to accurately model patient risk.…”

“…In addition, many studies do not control or report post-mortem interval to testing or storage conditions, which may affect material properties of the tissue. 22,23 Furthermore, some published methods have tested with air until failure 10,11 while others have tested with fluid. 13,14…”

“…When performing leak testing, most studies leverage ex vivo porcine tissue, 10,11,13,14 which is limited in its ability to closely mimic live tissue properties. Ex vivo testing often poorly controls or under-reports critical parameters governing tissue properties and behavior such as regulation of smooth muscle contractility, temperature, and osmolarity.…”

“…In addition, many studies do not control or report post-mortem interval to testing or storage conditions, which may affect material properties of the tissue. 22,23 Furthermore, some published methods have tested with air until failure 10,11 while others have tested with fluid. 13,14 Clinical results correlate intraoperative and postoperative leaks such as recent meta-analysis that reported a significantly higher rate of postoperative anastomotic leak among patients with a positive intraoperative air leak test (ie, leak observed upon inflation).…”

“…7 Leak testing is often performed intraoperatively in clinical settings to assess patency of the anastomosis before completing the procedure. Preclinical leak testing has been performed historically to assess performance of innovative devices compared to the standard of care 8,9 as well as to compare iterative design changes to staplers within [10][11][12] and across manufacturers. 13,14 However, many parameters in these testing protocols are not standardized, creating difficulty in drawing comparisons across studies.…”