An observational study in Adhesive Small Bowel Obstruction, Postoperative Abdominal Adhesions and Bowel Obstruction, sponsored by Alessio Giordano. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-22.
Sponsored by Alessio Giordano · Observational
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.
104 studies on the registry are indexed under Intestinal Obstruction; 15 are open to participants now.
This study's planned enrollment of 189 is above the median of 107 across 40 observational studies indexed under Intestinal Obstruction.
Browse Intestinal Obstruction studies →This is the only study on the registry with Alessio Giordano as lead sponsor.
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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.
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Age ≥ 18 years
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergoing surgery for ASBO who receive intraoperative 4DryField® PH application.
Patients undergoing surgery for ASBO without use of any antiadhesion agent.
Recurrence rate of adhesive small bowel obstruction (ASBO) within 12 months
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.
Time frame: 12 months post-surgery
Postoperative complications within 90 days
Incidence and type of postoperative complications occurring within 90 days after surgery, classified according to Clavien-Dindo classification.
Time frame: 90 days post-surgery
No study locations are listed for this record.
Plan to share: No — 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.
Start is estimated for Jul 2025; primary completion for Jul 2026, 12 months later.
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This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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