# Long-Term Safety and Efficacy of Alginate-Based Serosal Reinforcement (SEAL-G/SEAL-G MIST) Following Colorectal Anastomosis: A Multicenter, Comparative and Retrospective Cohort Study

## TL;DR

This study shows that using alginate-based sealants during colorectal surgery is safe and effective over 2–4 years, with no long-term complications and fewer early leaks.

## Contribution

The study provides long-term safety evidence for alginate-based sealants in colorectal anastomosis, extending prior short-term findings.

## Key findings

- Long-term complications at 1 year were 1.27% in the treatment group vs. 2.33% in the control group.
- No stenosis, stricture, or new complications occurred in the treatment group over 1–4 years.
- The 30-day anastomotic leak rate was 1.27% in the treatment group vs. 5.68% in the control group.

## Abstract

Background: Anastomotic leakage (AL) remains a major complication following colorectal surgery (3–19% incidence, 6–39% mortality). SEAL-G/SEAL-G MIST are alginate-based sealants for anastomotic reinforcement. While short-term safety and efficacy feasibility have been established in a previous study, this study reports long-term results. Methods: A multicenter, retrospective and comparative study at three centers (Israel, Italy). Retrospective Treatment group: 79 patients from the original study treated with SEAL-G/SEAL-G MIST during elective colon cancer resection (2021–2023). Retrospective Control group: 86 comparative patients with standard technique. Primary endpoint: Incidence of long-term complications (adhesions, stenosis, stricture, obstruction) at 1 year. Secondary endpoints: Complications at 1–4 years and 30-day AL rate. Non-inferiority assessed via Farrington–Manning method (margin 0.10). Results: Mean follow-up: 3.3 ± 0.63 years (treatment) vs. 3.4 ± 1.10 years (control). Groups were comparable for demographics and surgical characteristics. Long-term complications at 1 year: 1.27% (1/79) vs. 2.33% (2/86); 90% CI for difference: −0.067 to 0.046, p = 0.0048 (non-inferiority confirmed). No stenosis or stricture occurred in either group. No additional complications emerged at 1–4 years in the treatment group. Thirty-day AL rate: 1.27% (1/79) vs. 5.68% (5/88); all subclinical leaks (Grade B, n = 4) occurred in controls. Conclusions: Serosal reinforcement with alginate-based sealants does not introduce device-related long-term complications following colorectal anastomosis. The favorable short-term safety profile extends to 2–4 years. These findings support the safety of alginate-based sealants as anastomotic adjuncts, consistent with the paradigm of leak containment and severity reduction.