The results of the present study showed that the time for reconstruction using SLR was significantly shorter than that when SLR was not used. This is the first report to assess the clinical efficacy of SLR, which can reduce the time required for reconstruction after gastrectomy. Our results suggest the feasibility and effectiveness of SLR during laparoscopic gastrectomy.
Several factors associated with reduction time for reconstruction were considered. First, by attaching the SLR to conventional stapling devices, the tissue is crimped on the surface with a bioabsorbable reinforcing material, resulting in a high hemostatic effect on the dissected valgus deformity. In the present study, the incidence of hemostasis during anastomosis was significantly lower in the SLR group than that in the non-SLR group. In procedures using a conventional stapling device, it is often necessary to carefully stop bleeding from the stump of the intestine or stomach using soft coagulation; however, minor bleeding had almost completely disappeared when SLR was used.
Another useful point of using SLR is good handling of the stump of the intestine or stomach, which might contribute to the reduction in reconstruction time. Since the bioabsorbable material of the SLR continuously reinforces the staples pushed into the tissue, the cutoff end can be firmly grasped with laparoscopic forceps. To perform a gastroduodenostomy or esophagojejunostomy, the stump of each organ must be pulled in the appropriate direction and angled to obtain an accurate suture line. By grasping the staple surface reinforced by continuous SLR, the organs can be safely moved without damaging the tissue. The high hemostatic effect of SLR and the advantage of being able to grip the tissue gently may contribute to shortening the operation time.
In addition, SLR is used for duodenal transection during RY reconstruction; a flexible reinforcing material can effectively close the lumen without burying the stump, making it possible to close the duodenum safely and accurately. In a retrospective study of 965 patients with gastric cancer who underwent laparoscopic distal or total gastrectomy with RY reconstruction, it was reported that duodenal stump leakage occurred less frequently in the reinforcement than in the non-reinforcement group (0.67% vs. 5.71%, P < 0.001) [11]. On the other hand, the operative duration was extended by 33 min for laparoscopic distal gastrectomy and by 40 min for laparoscopic total gastrectomy in the reinforcement group compared to the non-reinforcement group [12]. SLR made from bioabsorbable materials could contribute to a reduction in duodenal stump leakage without prolonging the duration of surgery.
In the present study, no significant differences were observed in postoperative complications, including postoperative bleeding and anastomotic leakage. Previous studies have demonstrated that staple line treatment techniques, such as oversewing or SLR via roofing or buttressing, have been implemented to mitigate the risk of staple line complications [4, 13, 14]. Ojima et al. reported that no anastomosis-related complications such as anastomotic leakage, anastomotic stricture, and postoperative gastrointestinal bleeding were found in 24 consecutive patients with gastric cancer who underwent a reinforced stapling technique for reconstruction after laparoscopic distal gastrectomy [15]. Further studies with larger sample sizes are needed to further confirm the positive surgical outcomes in patients who received biomaterial reinforcement during laparoscopic gastrectomy for gastric cancer.
In a meta-analysis of randomized controlled trials for bariatric surgery, such as laparoscopic sleeve gastrectomy, suture oversewing seemed to be associated with a reduced risk of postoperative bleeding, staple line leak, and overall complications; however, no differences were found compared with bioabsorbable materials in the staple line [4]. The procedure for sleeve gastrectomy involves a mostly vertical stapled transection of the stomach and removal of the gastric fundus to create a tubular alimentary channel along the lesser curvature; reconstruction was not included. Elkomos et al. reported that the incidence of clinically significant postoperative pancreatic fistula was significantly lower in distal pancreatectomy (DP) with reinforced staplers than in DP with bare staplers [16]. Findings from previous studies and the results of the present study suggest that newly developed SLR made from bioabsorbable materials could reduce the risk of postoperative complications in comparison to no reinforcement.
This study has several limitations. First, it was conducted in a single institution with a relatively small number of subjects; thus, it could be affected by patient selection bias. Second, this was a retrospective single-arm observational study, and the fact that this was not a randomized controlled study could have led to selection bias. Therefore, the results of this study should be interpreted cautiously. A simple and reliable device for laparoscopic surgery is a promising application. Further studies with adequate statistical power and a larger number of patient subgroups are required to confirm the reliability and efficacy of this novel SLR for intracorporeal reconstruction during laparoscopic gastric cancer surgery.
In conclusion, the procedure using a stapler equipped with an SLR can reduce the time for reconstruction in laparoscopic gastrectomy for gastric cancer. During the transection of organs and reconstruction in laparoscopic gastrectomy for gastric cancer, the surgical procedure can be performed safely and accurately using SLR together with staplers. Further studies are required to confirm, update, and commercialize the product, taking the required costs into account, to confirm the universal utility of this device.