Assessing Determinants of Headway in Evaluating Risk of Adhesion: the ADHERE Study
| Registry | NCT07078981, acronym ADHERE |
|---|---|
| Status | Not yet recruiting |
| Study type | Observational |
| Enrollment | 189 (Estimated) |
| Sponsor | Alessio Giordano (Other); collaborators: PlantTec Medical GmbH |
| Conditions | Adhesive Small Bowel Obstruction, Postoperative Abdominal Adhesions, Bowel Obstruction, Abdominal Surgery Complications |
| Dates | start 2025-07-15 (estimated), primary completion 2026-07-15 (estimated), completion 2027-07-15 (estimated), first posted 2025-07-22, last updated 2025-07-22 |
Related Papers Related Patents Related Grants Related Experts
All trials for Adhesive Small Bowel Obstruction All trials for Postoperative Abdominal Adhesions
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 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. |
Sex: All, ages: 18 Years to any
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