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.
Undergoing surgical treatment for adhesive small bowel obstruction (ASBO)
Ability and willingness to provide informed consent
Willingness to adhere to follow-up visits
Presence of peritonitis
Intra-abdominal active malignancy
Pregnancy or breastfeeding
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.
Cohort
Prospective
Not listed
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.
Postoperative complications within 90 days
Incidence and type of postoperative complications occurring within 90 days after surgery, classified according to Clavien-Dindo classification.
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Alessio Giordano
Lead sponsor
Azienda Sanitaria di Firenze
Sponsor institution
PlantTec Medical GmbH
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
