Assessment of SEAL-G for Emergency patients requiring an anastomosis: The AGE audit of current practice.

Andrei Chitul; Eloise Lawrence; Paul Barach; Bijendra Patel; Hector Guadalajara; Damian Garcia-Olmo; Yrina Ghrabigi; Marisa Raquel Portela de Lima; Alec Engledow; Pasquale Giordano; Kate Hancorn; Marina Yiasemidou

doi:10.12688/f1000research.177281.1

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Study Protocol

Assessment of SEAL-G for Emergency patients requiring an anastomosis: The AGE audit of current practice.

[version 1; peer review: awaiting peer review]

Andrei Chitul¹, Eloise Lawrence¹, Paul Barach^2,3, [...] Bijendra Patel³, Hector Guadalajara⁴, Damian Garcia-Olmo⁴, Yrina Ghrabigi⁵, Marisa Raquel Portela de Lima¹, Alec Engledow¹, Pasquale Giordano¹, Kate Hancorn¹, Marina Yiasemidou ⁶

Andrei Chitul¹, Eloise Lawrence¹, [...] Paul Barach^2,3, Bijendra Patel³, Hector Guadalajara⁴, Damian Garcia-Olmo⁴, Yrina Ghrabigi⁵, Marisa Raquel Portela de Lima¹, Alec Engledow¹, Pasquale Giordano¹, Kate Hancorn¹, Marina Yiasemidou ⁶

PUBLISHED 15 Jun 2026

Author details Author details

¹ Colorectal Surgery, The Royal London Hospital, London, England, UK
² Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, USA
³ Queen Mary University of London Whitechapel Medical and Dental Library, London, England, UK
⁴ Surgery, Universidad Autonoma de Madrid Facultad de Medicina, Madrid, Community of Madrid, Spain
⁵ Imperial College London Division of Surgery, London, England, UK
⁶ Hull York Medical School, University of Hull Faculty of Health Sciences, Hull, England, UK

Andrei Chitul
Roles: Data Curation, Formal Analysis, Investigation, Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing

Eloise Lawrence
Roles: Data Curation, Formal Analysis, Investigation, Project Administration, Writing – Original Draft Preparation

Paul Barach
Roles: Conceptualization, Investigation, Project Administration, Supervision, Validation, Writing – Review & Editing

Bijendra Patel
Roles: Conceptualization, Project Administration, Supervision, Writing – Review & Editing

Hector Guadalajara
Roles: Conceptualization, Formal Analysis, Investigation, Methodology, Project Administration

Damian Garcia-Olmo
Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology

Yrina Ghrabigi
Roles: Data Curation, Investigation, Methodology

Marisa Raquel Portela de Lima
Roles: Data Curation, Investigation

Alec Engledow
Roles: Investigation, Methodology, Project Administration, Supervision, Writing – Review & Editing

Pasquale Giordano
Roles: Conceptualization, Investigation, Methodology, Project Administration, Supervision, Writing – Review & Editing

Kate Hancorn
Roles: Investigation, Methodology, Project Administration, Supervision, Writing – Review & Editing

Marina Yiasemidou
Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Software, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS AWAITING PEER REVIEW

Abstract

Background

Emergency abdominal surgery is associated with high morbidity and mortality, with anastomotic leak (AL) remaining a major postoperative complication. AL occurs in approximately 10% of emergency gastrointestinal (GI) anastomoses, increasing mortality threefold and often leading to reoperation, stoma formation, and prolonged hospitalisation. SEAL-G is a novel, fully synthetic, in-situ forming alginate hydrogel designed to reinforce GI anastomoses. It adheres mechanically without heat generation, provides flexibility compatible with bowel tissue, and is absorbed over several months. Pre-clinical data show SEAL-G potentially reduces severe leaks which in a clinical environment would warrant return to theatre. However, its efficacy in true life clinical settings and emergency GI surgery remains unstudied.

Aims

This study aims to (1) assess clinical outcomes following SEAL-G use in emergency GI anastomoses, (2) compare outcomes with matched controls without SEAL-G, and (3) evaluate surgeons’ perspectives on SEAL-G and other anastomotic leak preventive measures and its influence on decision-making regarding anastomosis versus stoma formation.

Methods

A multicentre, non-interventional, observational audit will be conducted across NHS and other hospitals where SEAL-G is available. Eligible patients (>16 years) undergoing emergency GI anastomosis will be included. Patients who underwent the anastomosis with the reinforcement of SEAL-G sealant will be compared with current or historical controls. Data on demographics, peri-operative variables, and post-operative outcomes—particularly AL rates—will be collected and compared with historical or contemporaneous controls using propensity matching. Additionally, a mixed-methods qualitative evaluation (surveys, interviews, focus groups, and ethnographic observation) will explore surgeons’ experiences, perceived safety, usability, and decision-making influences. A target of 160 patients will allow robust assessment across a heterogeneous emergency surgical population.

Keywords

emergency surgery, anastomotic leak, SEAL-G, gastrointestinal anastomosis, hydrogel sealant, tissue adhesive

Corresponding author: Marina Yiasemidou

Competing interests: No competing interests were disclosed.

Grant information: The author(s) declared that no grants were involved in supporting this work.

Copyright: © 2026 Chitul A et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Chitul A, Lawrence E, Barach P et al. Assessment of SEAL-G for Emergency patients requiring an anastomosis: The AGE audit of current practice. [version 1; peer review: awaiting peer review]. F1000Research 2026, 15:930 (https://doi.org/10.12688/f1000research.177281.1) First published: 15 Jun 2026, 15:930 (https://doi.org/10.12688/f1000research.177281.1) Latest published: 15 Jun 2026, 15:930 (https://doi.org/10.12688/f1000research.177281.1)

Background

Emergency abdominal surgery is a major contributor to surgical morbidity and mortality.^1–4 These procedures are often performed in deconditioned patients with physiological derangements,⁵ intra-abdominal contamination, or sepsis,⁶ which increases the complexity of intra-operative decision-making and the risk of post-operative complications. Additionally, many patients undergoing emergency surgery have pre-existing comorbidities that hinder peri-operative optimisation, to improve outcomes and reduce complications and recovery.⁷

Anastomotic leak (AL) remains one of the most severe and potentially life-threatening complications in gastrointestinal surgery, particularly in the emergency setting, where the incidence of AL is approximately 10%.^8–13 The occurrence of an AL is associated with a three-fold increase in mortality, a six-fold increase in the need for reoperation, and a significant impact on long-term quality of life due to complications such as stoma formation and prolonged hospitalisation. Comorbidities,⁸ inotrope use^14–16 and nutritional depletion⁸ are associated with increased risks of AL. Additionally, emergency surgery itself is an independent risk factor for AL.⁸

Surgeons often face the dilemma of whether to construct an anastomosis or perform a stoma. This decision is influenced by patient-related factors (hemodynamic instability, comorbidities, immunosuppression), intraoperative findings (degree of contamination, tissue quality), and institutional norms or resource availability.¹⁷ The fear of anastomotic failure can lead to a more conservative surgical approach, contributing to the high rate of potentially unnecessary stoma formation, with significant implications for patient outcomes and healthcare resources.^18–20

Various assessment tools have therefore been utilised to aid decision-making, alongside methods to enhance anastomotic integrity.²¹ One such approach involves the use of tissue adhesives used in addition to sutures or staples, providing a reinforcing layer of security to the anastomosis.²² In cases of equipoise, this may enable the creation of a safer anastomosis, potentially sparing the patient from the complications of a stoma and the need for a subsequent reversal surgery.

Commercially available adhesives and sealants have historically been evaluated for use as adjuncts to standard anastomosis techniques, including fibrin and cyanoacrylate technologies, however none has been significantly adopted. Fibrin sealants are widely used as effective haemostatic agents but have not demonstrated requisite durability of sealing or mechanical reinforcement to provide lasting protection to anastomoses.²³

Cyanoacrylate (CA) adhesives provides high tensile strength reinforcement although requires precise application to tissue. Some formulations generate heat during polymerisation which could damage friable tissues, therefore not suitable for use in the emergency setting particularly if there is concern of tissue viability. Cyanoacrylate is associated in pre-clinical anastomotic models with increases in stricture, foreign body reaction and inflammatory response. Additionally low cyanoacrylate flexibility is mismatched to bowel tissue which could affect healing process.²⁴

SEAL-G is a novel, fully synthetic, in-situ forming hydrogel developed by Advanced Medical Solutions for the reinforcement of gastrointestinal anastomoses. The alginate sealants are applied extraluminally over the completed anastomosis, provide strong sealant properties and fully cure without temperature increase. The novel alginate formulation is highly flexible and uniquely adheres to tissue through mechanical interaction, thereby avoiding downsides of chemical and biological mechanisms. In porcine models, SEAL-G has demonstrated a statistically significant reduction in leak rates and increased burst pressure. It is absorbed over three to four months in vivo. SEAL-G therefore provides effective protection of the anastomosis during the healing phase.

SEAL-G has CE-marking and MHRA approval for clinical use in the UK. Early elective clinical data suggests SEAL-G is safe, easy to use, and well tolerated. Despite promising results in elective settings, SEAL-G has not yet been studied in emergency gastrointestinal surgery.

Aims

Aim 1: Determine the clinical outcomes of the use of SEAL-G sealants on gastrointestinal anastomosis in patients who underwent emergency surgery. The primary outcome will be anastomotic leak. Severity and need for return to theatre will also be recorded.

Aim 2: Compare the clinical outcomes of patients who underwent gastrointestinal (GI) anastomosis during emergency surgery with SEAL-G sealants to matched controls who underwent the same procedure without SEAL-G alginate sealants.

Aim 3: Assess the views of surgeons about the use of SEAL-G in emergency surgery and the impact on surgical decision making to perform a stoma or an anastomosis.

Ethics and consent:

Informed written consent is obtained from each patient for the use of the anastomotic sealant as standard practice.

Objectives

Objective 1: Assess the clinical outcomes of the use of SEAL-G in emergency patients who have had a GI anastomosis. The primary outcome will be anastomotic leak.

Objective 2: Evaluate how the clinical outcomes of the use of SEAL-G in emergency patients who have had a GI anastomosis compare to appropriately matched current or historical controls.

Objective 3: Assess whether the potential for usage of the SEAL-G adhesive and or other methods for prevention of anastomotic leak, has impacted on the decision of the surgeon to form or not form an anastomosis.

Methodology

Study design

This is a non-interventional, observational audit of practice which will aim to assess the clinical outcomes and the impacts on decision making of the usage of SEAL-G adhesive sealant on GI anastomosis in patients requiring emergency surgery.

SEAL-G is available for use in the NHS and other healthcare systems worldwide, with CE-marking and MHRA approval for clinical use. The appropriate training of both the medical staff and the scrub nurses was provided prior to usage by Advanced Medical Solutions. A representative of Advanced Medical Solutions will be present to support the implementation process for the initial cases of each surgeon and continued support is provided as per request of the surgeon or theatre team.

Adult patients undergoing any form of anastomosis as an emergency or urgent procedure will be included in this study. This includes patients receiving both an anastomosis and a defunctioning stoma. Data will be collected prospectively and retrospectively, as concurrent or historical controls will be used to compare outcomes between cases where SEAL-G was applied and those where it was not. The sealant is available for use in both open and laparoscopic procedures.

When possible (prospective data collection) the cases for which the sealant was not adequately or successfully applied will also be recorded and reasons for this will be sought by open question interviews with the primary surgeon.

Inclusion criteria

• Patients over the age of 16
• Undergoing emergency surgery as per CEPOD classification²⁵
• Undergoing primary anastomosis (with or without a defunctioning stoma)
• Intraoperative decision to apply SEAL-G

Exclusion criteria

• Patients under the age of 16
• Patients who did not have a GI anastomosis
• Positive leak test/negative ICG assessment requiring anastomosis takedown and/or re-anastomosis.
• Intraoperative use of sealant, adhesive or any buttressing material to an anastomosis, other than the SEAL-G/SEAL-G MIST

Key measurements

The following data will be collected for each case. Patient details will be anonymised and collected on a secure server. The below data will also be collected for emergency cases that underwent a GI anastomosis without the use of SEAL-G. This will be done either prospectively or retrospectively to allow for the identification of appropriate controls for the propensity score matching.

(i) Patient demographics:
- - Hospital number
- - Gender
- - Age
- - ASA
- - Clinical Frailty Score
(ii) Pre-operative information:
- Date and time of admission
- Date and time of operation
- Indication for operation
- Emergency Surgery Score (NELA, P-POSSUM)
- Pre-operative inotropic use
- Highest CRP within 48 hours of operation
- Malnutrition Universal Screening Tool²⁶
- Number of days prior to operation that patient was nil by mouth
- Number of days prior to operation that patient was on normal diet
(iii) Peri-op information:
- Type of operation/s (e.g. small bowel resection, colectomy)
- Mode of operation (e.g. open, laparoscopic, laparoscopic converted to open)
- Procedure additional to resection of bowel (e.g. resection of solid organ)
- Degree of contamination (no contamination, localised abscess, purulent peritonitis in more than one quadrant of the abdomen, faeculent peritonitis in more than one quadrants of the abdomen)
- Anatomical components of anastomosis (small bowel to small bowel, small bowel to colon, colon to colon, colon to rectum, small bowel to rectum, stomach to small bowel, other please specify)
- Type of anastomosis (hand sewn, stapled anastomosis – if stapled fully or enterotomies hand sawn, staple line reinforced/staple line buried, other please specify)
- Level of anastomosis (if small bowel distance from DJ flexure, if colocolonic which parts of colon, if rectum involved level of anastomosis from anal verge)
- Defunctioning stoma (if yes type – ileostomy/colostomy)
- Use of ICG, flexible sigmoidoscopy for visualisation of anastomosis, leak test
- Intraoperative use of two or more units of RBCs
- Intraoperative use of inotropes
- Successful application of adhesive (has the surgeon applied appropriately all around the anastomosis)
- Length of surgery
(iv) Post-operative information:
- Date of discharge
- HDU/ICU admission
- LOS in HDU/ICU
- 30-day complication Clavien Dindo Classification
- 90-day complication Clavien Dindo classification
- Anastomotic leak – Modified International Study group for rectal cancer classification²⁷:
- o Grade A anastomotic leak: results in no change in patients’ care
- o Grade B leakage: requires intervention but manageable without return to theatre
- o Grade C anastomotic leak which requires return to theatre
- Time of AL <3 days or > 3 days
- Prolonged inotropic use (>48 hrs)
- Prolonged intubation (>48 hrs)
- Time to oral intake – if no oral intake time to enteric feed
- Parenteral feeding

Assessing the opinion of surgeons on SEAL-G

In alignment with Aims 1 and 2, we will conduct ‘intensive implementation modules’ while surgeons implement the SEAL-G sealant over one-month periods. Using an iterative, mixed methods approach of structured questionnaires, in-depth interviews, and focus group discussions with participating surgeons, we will explore implementation and perceptions of the SEAL-G sealant and whether the availability of SEAL-G influences the decision to perform an anastomosis versus stoma formation in emergency gastrointestinal surgery.

We will selectively recruit and enrol surgeons to participate in a qualitative evaluation of SEAL-G use in emergency gastrointestinal surgery. Decision-making in the emergency surgical setting is a complex, multifactorial process influenced by individual, team, institutional, and system-level factors. The application of SEAL-G as an adjunct to anastomotic reinforcement may require local adaptation due to contextual variability—including differences in clinical culture, operating room workflows, resource availability, and interprofessional collaboration. These factors may result in diverse real-world implementation ‘phenotypes’, necessitating a nuanced understanding of the intervention’s integration into practice. To achieve this, we will use a mixed-methods approach including surveys and interviews.

Surveys: We will develop a structured questionnaire to assess surgeon attitudes, willingness to adopt SEAL-G, and perceived barriers and facilitators to its use. Key domains will include perceptions of safety and efficacy, prior experience with tissue adhesives, acceptability within the emergency context, and impact on clinical decision-making.

Interviews: We will conduct interviews with 10 surgeons. Interviews are an important information source about how individuals think about AL and SEAL-G quality and efficacy. Interview confidentiality will encourage interviewees to speak openly about their values, beliefs, and conceptions that underpin and shape professional practice. Interview questions will focus on assessing the local adaptation and implementation of SEAL-G sealant, and the individualistic perceptions of the utility of each component. We will inquire specifically about barriers to change including the culture and work environment, and factors that are most important for surgeon decision making under emergency conditions.

Data analysis

Objective 1: Descriptive statistics will be used for the presentation of the clinical outcomes. The primary outcome will be 30-day AL. AL will be documented and classified as above.

Objective 2: Propensity score matching will be applied for comparisons of the results of the current cohort to the ones of current (prospective data collection) or historic controls (retrospective). Historical matched controls will be identified from hospital surgical databases. Propensity score matching will be used to match on:

• Age
• ASA grade
• Surgery performed
• Contamination degree
• Type of anastomosis
• Defunctioning stoma presence

Outcomes will be compared using appropriate statistical tests (chi-squared, t-tests, logistic regression), adjusted for matching variables.

Objective 3: Survey results will be analysed using mainly descriptive sttistics.

Qualitative data analysis: Interviews and focus groups will be digitally recorded and transcribed to ensure accuracy of data collection. Transcripts will be analysed using a computer-assisted qualitative data analysis software (MAXQDA). During analysis, categorical themes will be identified and applied to further transcripts. We will conduct a hybrid form of textual analysis analysed by two independent assessors which will combine deductive codes from the CFIR domains and constructs and inductive codes identified from the data as in our prior work. We will use a cross-case comparison to consider how the same mechanism was carried out in different hospital contexts.2 Rather than “generalizability” our goal with the qualitative research findings will be “transferability” which will be increased by providing details of the reasons and types of adaptations and the contextual factors of each NHS trust).

Standard descriptive statistics will be applied for analysis of questionnaire responses. The analytic strategy is informed by the task at hand as well as the desire to allow unanticipated themes to emerge from the data and to allow participants’ understandings to come to the fore, as in our prior work. We plan to adapt the conceptual framework for analysing textual data, proposed by Corbin and Strauss.²⁸ It includes categories of context, practices/processes, professional interactions, and consequences. The individual cells report the implication of the structure on our analysis of the data.

Results and Conclusion

This mixed-methods audit of practice offers preliminary insights into the safety, feasibility, and clinical utility of SEAL-G in GI anastomoses in the emergency setting. Through propensity score matching, this study aims to elucidate whether the use of SEAL-G influences postoperative outcomes, most notably, the incidence of AL, a potentially catastrophic complication. The qualitative data collection of this project will give an insight as to if having SEAL-G in a surgeon’s armoury will prevent the formation of stoma in cases of equipoise, whereby an anastomosis is safe to perform.

Impact

Preventing AL in high-risk emergency surgical patients remains a critical challenge, as these individuals frequently present with significant physiological compromise and comorbidities. We will assess the impact of adherence to best practice AL prevention process measures, and quality and safety culture. The availability of an adjunct like SEAL-G, which may provide an additional layer of protection against anastomotic failure, could represent a paradigm shift in managing these vulnerable patients. Furthermore, its use could help reduce the incidence of stoma formation, an outcome that carries long-term morbidity and impacts quality of life.

Publication and authorship policy

Collaborators who provide data within the department towards this study will be cited with collaborative authorship in any publications.

Data availability

Data availability is not applicable as this is a study protocol.

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