Annals of Coloproctology

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Complications

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: Moshe Kamar, Fahim Kanani, Antonio Spinelli, David Jayne, Lior Segev, Matt Tutton, Isacco Montroni, Hagit Tulchinsky, Mordechai Shimonov, Ron Lavy, Oded Zmora; Ann Coloproctol. 2025;41(5):424-433. Published online October 23, 2025; DOI: https://doi.org/10.3393/ac.2025.00297.0042

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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 identifier: NCT04532515

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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
Fahim Kanani, Antonino Spinelli, Mordechai Shimonov, Husam Zbede, Nouha Hinnawi, Ron Lavy, Oded Zmora, Moshe Kamar
Journal of Clinical Medicine.2026; 15(4): 1448. CrossRef

Predisposing factors for high output stoma in patients with a diverting loop ileostomy after colorectal surgeries: Dan Assaf, David Hazzan, Almog Ben-Yaacov, Shachar Laks, Douglas Zippel, Lior Segev; Ann Coloproctol. 2023;39(2):168-174. Published online August 6, 2021; DOI: https://doi.org/10.3393/ac.2021.00241.0034

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6 Web of Science
10 Citations

Abstract PDF

Purpose
One of the most common ileostomy-related complications is high output stoma (HOS) which causes significant fluids and electrolytes disturbances. We aimed to analyze the incidence, severity, and risk factors for readmission for HOS.
Methods
We reviewed all patients who underwent loop ileostomy closure in a single institution between 2010 and 2020. Patients that were readmitted for dehydration due to HOS during the time interval between the creation and the closure of the stoma were identified and divided into a study (HOS) group. The remaining patients constructed the control group.
Results
A total of 307 patients were included in this study, out of which, 41 patients were readmitted 73 times (23.7% readmission rate) for the HOS group, and the remaining 266 patients constructed the control group. Multivariate analysis identified; advanced American Society of Anesthesiologists (ASA) physical status (PS) classification, elevated baseline creatinine, and open surgery as risk factors for HOS. Renal function worsened among the entire cohort between the construction of the stoma to its closure (mean creatinine of 0.82 vs. 0.96, P<0.0001).
Conclusion
Loop ileostomy formation is associated with a substantial readmission rate for dehydration as a result of HOS, and increasing the risk for renal impairment during the duration of the diversion. We identified advanced ASA PS classification, open surgery, and elevated baseline creatinine as predictors for HOS.

Citations

Citations to this article as recorded by

High output stoma after surgery for rectal cancer - a risk factor for low anterior resection syndrome?
Xuena Zhang, Qingyu Meng, Jianna Du, Zhongtao Tian, Yinju Li, Bin Yu, Wenbo Niu
BMC Gastroenterology.2025;[Epub] CrossRef
Atrial Flutter With Intraventricular Conduction Delay, Hypotension, and Bradycardia in the Setting of High-Output Ileostomy With Renal Failure, Hyperkalemia, and Metabolic Acidosis: A Case Report With Brief Literature Review
Edinen Asuka, Barbara Odac, Andrew Ndakotsu, Anastasia Postoev
Cureus.2025;[Epub] CrossRef
Preoperative High Agatston Score in Aorta Leads to Postoperative High-Output Ileostomy
Yusuke Kono, Manabu Yamamoto, Chiharu Yasui, Ryo Ishiguro, Takuki Yagyu, Kyoichi Kihara, Tomoyuki Matsunaga, Shuichi Takano, Naruo Tokuyasu, Teruhisa Sakamoto, Yoshiyuki Fujiwara
Journal of Surgical Research.2025; 314: 139. CrossRef
A review of chyme reinfusion: new tech solutions for age old problems
Chen Liu, Sameer Bhat, Ian Bissett, Gregory O'Grady
Journal of the Royal Society of New Zealand.2024; 54(2): 161. CrossRef
Knowledge, attitudes, practices and associated factors regarding high output stoma of ileostomy among colorectal surgical nurses: a multicentre cross-sectional study
Qing Zhang, Jianan Sun, Dongxue Wang, Quan Wang, Haiyan Hu
Supportive Care in Cancer.2024;[Epub] CrossRef
Morphological predictors of water-electrolyte disorders in patients with preventive ileostomy after rectal resection for cancer
A.I. Maksimkin, Z.A. Bagatelia, V.M. Kulushev, E.N. Gordienko, M.S. Lebedko, S.S. Anikina, E.P. Shin
Pirogov Russian Journal of Surgery.2024; (4): 16. CrossRef
The Frequency of Stoma-Related Readmissions After Emergency and Elective Ileostomy Formation: The Leicester Experience
Ting-Wei Wu, Wen Yuan Chung, Hui En Jewel Ng, Ashley Yap, Konstantinos Baronos, Deepak Paul, Christopher P Neal, David Bowrey
Cureus.2024;[Epub] CrossRef
Predictors of High-output Stoma in Diverting Ileostomy for Rectal Cancer Surgery
Hiroaki Uehara, Hitoshi Kameyama, Toshiyuki Yamazaki, Akira Iwaya, Yuya Enoki
Nippon Daicho Komonbyo Gakkai Zasshi.2023; 76(3): 286. CrossRef
Morpho-functional aspects of various parts of the intestine and risk factors associated with the preventive ileostomy (review)
A. I. Maksimkin, Z. A. Bagatelia, E. N. Gordienko, E. B. Emelyanova, D. M. Sakaeva
Koloproktologia.2023; 22(4): 147. CrossRef
Obstructive and secretory complications of diverting ileostomy
Shingo Tsujinaka, Hideyuki Suzuki, Tomoya Miura, Yoshihiro Sato, Chikashi Shibata
World Journal of Gastroenterology.2022; 28(47): 6732. CrossRef

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