Adhesion Prevention in ASBO Surgery Using 4DryField® PH

NCT07078981 | Not Yet Recruiting DMC

• 1 other identifier: ADHERE2025
• Study Type: observational
• Target: 189
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Postoperative complications within 90 days

  90 days post-surgery

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• Presence of peritonitis
• Intra-abdominal active malignancy
• Pregnancy or breastfeeding

Sponsors & Collaborators

• Alessio Giordano: lead
• PlantTec Medical GmbH: collaborator

Related Publications (3)

• 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.

  PMID: 31093531 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.

  PMID: 29030779 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.

  PMID: 21775773 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Intestinal Obstruction; Tissue Adhesions; Bites and Stings; Abdomen, Acute

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Abdominal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Signs and Symptoms, Digestive

Central Study Contacts

carlo bergamini, MD, General Surgeon

CONTACT

+393476360711; drcarlobergamini@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, General Surgeon

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: July 22, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): July 15, 2027
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share