Adhesion Prevention in ASBO Surgery Using 4DryField® PH (ADHERE)

July 14, 2025 updated by: Alessio Giordano

Assessing Determinants of Headway in Evaluating Risk of Adhesion: the ADHERE Study

Post-surgical adhesions occur in up to 90% of abdominal surgeries, often leading to complications like adhesive small bowel obstruction (ASBO) and chronic pain. They result from imbalanced healing processes influenced by growth factors, fibroblast activity, and genetic predispositions. While surgery can relieve ASBO, it frequently causes new adhesions, with recurrence rates up to 40%. Anti-adhesion barriers, such as the starch-based 4DryField® PH, form a temporary gel barrier to support healing. Though promising, its role in preventing ASBO recurrence is not well studied. This study evaluates whether intra-operative use of 4DryField® PH reduces ASBO recurrence over 12 months and compares perioperative outcomes in treated vs. untreated patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Post-surgical adhesions are a common complication of abdominal surgery, with an occurrence rate of approximately 79-90%, leading to significant morbidity such as adhesive small bowel obstruction (ASBO) and chronic pain (1,2). These adhesions result from increased extracellular matrix production, reduced fibrinolytic activity, and the influence of growth factors like TGF-beta and VEGF, along with fibroblast proliferation(1). Genetic predispositions-affecting pathways such as TGF-β, VEGF, PAI-1, MMPs, and various pro-inflammatory cytokines-may increase the risk of adhesion formation(2-5).

Surgical management of ASBO resolves acute symptoms but often exacerbates the underlying issue by inducing further peritoneal trauma. Recurrence rates remain high-reported in up to 40% of patients-and complications from repeated adhesiolysis include increased operative time, bowel injury, and postoperative morbidity(6).

Various strategies have been explored in different surgical fields to prevent adhesion formation, including the use of physical antiadhesion barriers(7-9). Among these, 4DryField® PH, a plant-derived starch powder, has been shown to be safe and effective in clinical and experimental studies(8,10). When hydrated with saline, the powder forms a biocompatible gel that acts as a temporary barrier to physically separate traumatized serosal surfaces and allow for proper mesothelial regeneration.

Although the use of 4DryField® PH has been studied in different settings, there is limited prospective evidence evaluating its role in preventing recurrence of ASBO.

The present study aims to fill this gap by assessing whether intraoperative application of 4DryField® PH during surgery for ASBO reduces the recurrence rate during a 12-month follow-up, and by comparing perioperative outcomes between treated and untreated patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
189

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients undergoing surgery for adhesive small bowel obstruction (ASBO), including those with or without application of an antiadhesion agent, in real-world clinical settings.

Description

Inclusion Criteria:

Age ≥ 18 years

  • Undergoing surgical treatment for adhesive small bowel obstruction (ASBO)
  • Ability and willingness to provide informed consent
  • Willingness to adhere to follow-up visits

Exclusion Criteria:

  • Presence of peritonitis
  • Intra-abdominal active malignancy
  • Pregnancy or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Antiadhesion Group
Patients undergoing surgery for ASBO who receive intraoperative 4DryField® PH application.
No Antiadhesion Group
Patients undergoing surgery for ASBO without use of any antiadhesion agent.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recurrence rate of adhesive small bowel obstruction (ASBO) within 12 months
Time Frame: 12 months post-surgery
Percentage of patients who experience a recurrence of adhesive small bowel obstruction (ASBO), based on clinical symptoms and imaging findings, during the 12-month follow-up period. Recurrence is defined by standardized clinical criteria (e.g. intermittent pain, nausea, vomiting, bowel obstruction symptoms) with or without radiological confirmation.
12 months post-surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative complications within 90 days
Time Frame: 90 days post-surgery
Incidence and type of postoperative complications occurring within 90 days after surgery, classified according to Clavien-Dindo classification.
90 days post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alessio Giordano

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
PlantTec Medical GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ADHERE2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual participant data (IPD) will be shared. Data collected in this study will be used solely for the purposes described in the protocol and will not be made available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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