Evidence map›Paper›PMID 41125251›Full record

ArticleAnnals of coloproctology2025

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 and 1 more

Registry-linked trialAbstract read
In one paragraph

Article in Annals of coloproctology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04532515 (Seal-G and Seal-G MIST Study for Reinforcement and Protection of Colonic Anastomoses in Subjects Undergoing Colonic Resection), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04532515 nacompletednot on this map

Seal-G and Seal-G MIST Study for Reinforcement and Protection of Colonic Anastomoses in Subjects Undergoing Colonic Resection

TypeinterventionalSponsorAdvanced Medical Solutions Ltd.Ran2021 to 2023Enrolled160ConditionsColon Cancer, Gastrointestinal CancerArmsSeal-G Surgical Sealant, Seal-G MIST System
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Moshe KamarSurgical Department, Wolfson Medical Center, Holon, Israel.
Fahim KananiSurgical Department, Wolfson Medical Center, Holon, Israel.
Antonio SpinelliDepartment of General Surgery and Colorectal Unit, IRCCS Humanitas Research Hospital, Milan, Italy.
David JayneDepartment of General Surgery and Colorectal Unit, St James's Hospital, Leeds, UK.
Lior SegevColorectal Unit, Surgical Department, Sheba Tel Ha-Shomer Medical Center, Ramat Gan, Israel.
Matt TuttonDepartment of General Surgery and Colorectal Unit, Colchester General Hospital, Colchester, UK.
Isacco MontroniColorectal Surgery Unit, Ospedale S. Maria delle Croci, Ravenna, Italy.
Hagit TulchinskyColorectal Unit, Surgical Department, Ichilov Medical Center, Tel Aviv, Israel.
Mordechai ShimonovSurgical Department, Wolfson Medical Center, Holon, Israel.
Ron LavySurgical Department, Shamir Medical Center, Beer Yackov, Israel.
Oded ZmoraSurgical Department, Shamir Medical Center, Beer Yackov, Israel.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis 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.

methodsThis 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.

resultsThe 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).

conclusionAlginate-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.

Indexed as

Anastomotic leakColorectal surgeryPatient safetyTissue adhesivesWound healing

Identifiers

PMID41125251
PMCPMC12569779

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.