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| Name | Class |
|---|---|
| PlantTec Medical GmbH | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications within 90 days | Incidence and type of postoperative complications occurring within 90 days after surgery, classified according to Clavien-Dindo classification. | 90 days post-surgery |
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Inclusion Criteria:
Age ≥ 18 years
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| carlo bergamini, MD, General Surgeon | Contact | +393476360711 | drcarlobergamini@gmail.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31093531 | Result | Ahmad M, Crescenti F. Significant Adhesion Reduction with 4DryField PH after Release of Adhesive Small Bowel Obstruction. Surg J (N Y). 2019 May 10;5(1):e28-e34. doi: 10.1055/s-0039-1687857. eCollection 2019 Jan. | |
| 29030779 | Result | Lorentzen L, Oines MN, Oma E, Jensen KK, Jorgensen LN. Recurrence After Operative Treatment of Adhesive Small-Bowel Obstruction. J Gastrointest Surg. 2018 Feb;22(2):329-334. doi: 10.1007/s11605-017-3604-x. Epub 2017 Oct 13. |
| Label | URL |
|---|---|
| Related Info | View source |
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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.
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| ID | Term |
|---|---|
| D007415 | Intestinal Obstruction |
| D000267 | Tissue Adhesions |
| D001733 | Bites and Stings |
| D000006 | Abdomen, Acute |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D002921 | Cicatrix |
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| 21775773 | Result | Awonuga AO, Fletcher NM, Saed GM, Diamond MP. Postoperative adhesion development following cesarean and open intra-abdominal gynecological operations: a review. Reprod Sci. 2011 Dec;18(12):1166-85. doi: 10.1177/1933719111414206. Epub 2011 Jul 20. |
| D005355 |
| Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |
| D015746 | Abdominal Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |