Efficacy and safety of novel alginate-based sealants (SEAL-G and SEAL-G MIST) in reducing anastomotic leakage following colorectal anastomosis: a prospective multicenter study.

Kamar, M.; Kanani, F.; Spinelli, A.; Jayne, D.; Segev, L.; Tutton, M.; Montroni, I.; Tulchinsky, H.; Shimonov, M.; Lavy, R.; Zmora, O.

Efficacy and safety of novel alginate-based sealants (SEAL-G and SEAL-G MIST) in reducing anastomotic leakage following colorectal anastomosis: a prospective multicenter study.

All Authors

Kamar, M.

Kanani, F.

Spinelli, A.

Jayne, D.

Segev, L.

Tutton, M.

Montroni, I.

Tulchinsky, H.

Shimonov, M.

Lavy, R.

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LTHT Author

Jayne, David

LTHT Department

Abdominal Medicine & Surgery
General Surgery

Publication Date

2025

Item Type

Journal Article

Abstract

PURPOSE: This study aimed to evaluate the efficacy, usability, and safety of the novel alginate-based sealants SEAL-G and SEAL-G MIST in reducing anastomotic leakage after colorectal resection. METHODS: This prospective, multicenter study enrolled 160 patients undergoing elective colonic resection with primary anastomosis at 8 centers. SEAL-G was applied in open procedures (n=33), and SEAL-G MIST was used for minimally invasive procedures (n=127), with both sealants applied circumferentially to the anastomotic site. The primary endpoints included the rate of anastomotic coverage and the incidence of leakage within 30 days, classified according to the International Study Group of Rectal Cancer (ISGRC) criteria. RESULTS: The overall anastomotic leak rate was 3.1% (5 of 160), with only 1 patient (0.6%) experiencing a grade C leak that required reoperation. Four patients (2.5%) developed grade A or B leaks, all of which were managed conservatively. Complete circumferential sealant coverage was achieved in 93.1% of cases. The overall leak rates were 6.1 percent and 2.4 percent, respectively. However, statistical analysis did not show a significant difference. Mean hospital stay was significantly shorter after laparoscopic surgery compared to open surgery (5.1+/-2.8 days vs. 8.4+/-5.5 days, P<0.001). CONCLUSION: Alginate-based sealants show promise in reducing the severity of anastomotic leaks and in supporting anastomotic healing, demonstrating high technical success and low complication rates. Trial registration: ClinicalTrials.gov iden-tifier: NCT04532515.