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. 2023 May 11;23(1):121.
doi: 10.1186/s12893-023-02027-1.

Novel external reinforcement device for gastrointestinal anastomosis in an experimental study

Hiro Hasegawa  1   2 , Nobuyoshi Takeshita  1   2 , Woogi Hyon  3 , Suong-Hyu Hyon  3 , Masaaki Ito  4   5
Affiliations

Novel external reinforcement device for gastrointestinal anastomosis in an experimental study

Hiro Hasegawa et al. BMC Surg. .

Abstract

Background: Anastomotic leakage has been reported to occur when the load on the anastomotic site exceeds the resistance created by sutures, staples, and early scars. It may be possible to avoid anastomotic leakage by covering and reinforcing the anastomotic site with a biocompatible material. The aim of this study was to evaluate the safety and feasibility of a novel external reinforcement device for gastrointestinal anastomosis in an experimental model.

Methods: A single pig was used in this non-survival study, and end-to-end anastomoses were created in six small bowel loops by a single-stapling technique using a circular stapler. Three of the six anastomoses were covered with a novel external reinforcement device. Air was injected, a pressure test of each anastomosis was performed, and the bursting pressure was measured.

Results: Reinforcement of the anastomotic site with the device was successfully performed in all anastomoses. The bursting pressure was 76.1 ± 5.7 mmHg in the control group, and 126.8 ± 6.8 mmHg in the device group, respectively. The bursting pressure in the device group was significantly higher than that in the control group (p = 0.0006).

Conclusions: The novel external reinforcement device was safe and feasible for reinforcing the anastomoses in the experimental model.

Keywords: Anastomosis; Anastomotic leakage; Colorectal surgery; Reinforcement; Sealant.

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Conflict of interest statement

HH, NT, and MI received experimental animals and a novel external reinforcement device for gastrointestinal anastomosis from BMG Incorporated, Kyoto, Japan. National cancer center, WH and SHH have a patent of the novel external reinforcement device. WH and SHH are employees of BMG Incorporated, Kyoto, Japan. WH and SHH had no role in the analysis or interpretation of the data. Conflicts of interest are properly managed in accordance with the regulations of each institution.

Figures

Fig. 1
Fig. 1
Novel external reinforcement device. a The outer sheet consists of polyglycolic acid. b The inner sealant consists of LYDEX®
Fig. 2
Fig. 2
Reinforcement of the anastomosis using the device. White arrow indicates the anastomosis. The device is wrapped around the gastrointestinal tract. Saline is infiltrated from the outside to the gel LYDEX®. The device is adhered to the gastrointestinal tract
Fig. 3
Fig. 3
Bursting model. Black arrow head indicates the manometry catheter. Black arrow indicates a 10-Fr silicone tube. White arrow indicates the anastomosis
Fig. 4
Fig. 4
Perforation of the gastrointestinal tract. White arrow heads indicate the mesenteric emphysema. White arrow indicates the anastomosis covered with the device
Fig. 5
Fig. 5
Bursting pressure. Black arrow indicates the bursting pressure
Fig. 6
Fig. 6
Comparison of the average bursting pressure between the two groups
Fig. 7
Fig. 7
Histological findings (periodic acid-Schiff stain). Black arrow head indicates LYDEX®. a High ability to adhere to the porcine gastrointestinal tract. b Enlarged view of the red rectangle in a
See this image and copyright information in PMC

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