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Adhesion Prevention in ASBO Surgery Using 4DryField® PH

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07078981
Acronym
ADHERE
Enrollment
189
Registered
2025-07-22
Start date
2025-07-15
Completion date
2027-07-15
Last updated
2025-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Surgery Complications, Adhesive Small Bowel Obstruction, Bowel Obstruction, Postoperative Abdominal Adhesions

Keywords

adhesion, obstruction, acute abdomen, emergency surgery, 4DryField, adhesiolysis, antiadhesion barrier, ASBO, abdominal surgery, peritoneal adhesion

Brief summary

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.

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.

Interventions

None listed

Sponsors

PlantTec Medical GmbH
CollaboratorUNKNOWN
Alessio Giordano
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Recurrence rate of adhesive small bowel obstruction (ASBO) within 12 months12 months post-surgeryPercentage 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.

Secondary

MeasureTime frameDescription
Postoperative complications within 90 days90 days post-surgeryIncidence and type of postoperative complications occurring within 90 days after surgery, classified according to Clavien-Dindo classification.

Contacts

Primary Contactcarlo bergamini, MD, General Surgeon
drcarlobergamini@gmail.com+393476360711

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026