Adhesive Small Bowel ObstructionADHERENCT07078981
Adhesion Prevention in ASBO Surgery Using 4DryField® PH
An observational study of Adhesive Small Bowel Obstruction and Postoperative Abdominal Adhesions, run by Alessio Giordano.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adhesive Small Bowel Obstruction, Postoperative Abdominal Adhesions, Bowel Obstruction
- How many people
- 189 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2025to 15 Jul 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Presence of peritonitis
- Intra-abdominal active malignancy
- Pregnancy or breastfeeding
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessing Determinants of Headway in Evaluating Risk of Adhesion: the ADHERE Study
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.
Read the detailed description
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.
- 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
- Medical subject headings
- Intestinal Obstruction, Tissue Adhesions, Bites and Stings, Abdomen, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months post-surgery
Secondary outcomes (1)
Postoperative complications within 90 days
Incidence and type of postoperative complications occurring within 90 days after surgery, classified according to Clavien-Dindo classification.
Measured: 90 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start15 Jul 2025 (estimated)
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Adhesive Small Bowel ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 189 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Alessio Giordano
- Sponsor type
- University, hospital or other
- Collaborators
- PlantTec Medical GmbH
- Responsible party
- Sponsor-investigator, Alessio Giordano, Azienda Sanitaria di Firenze
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07078981
- Sponsor's protocol ID
- ADHERE2025
- Acronym
- ADHERE
- Status last verified
- Jul 2025
- First submitted
- 14 Jul 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 31093531Lorentzen 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.
PubMed 29030779Awonuga 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.
PubMed 21775773
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Determinants of Headway in Evaluating Risk of Adhesion: the ADHERE Study
- ClinicalTrials.gov ID
- NCT07078981
- Acronym / sponsor ID
- ADHERE / ADHERE2025
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 189 participants (estimated)
- Lead sponsor
- Alessio GiordanoUniversity, hospital or other
- Collaborators
- PlantTec Medical GmbH
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Presence of peritonitis
- Intra-abdominal active malignancy
- Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recurrence rate of adhesive small bowel obstruction (ASBO) within 12 months
Time frame: 12 months post-surgery
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.
1 secondary outcome
Postoperative complications within 90 days
Time frame: 90 days post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Results publication: PubMed 31093531Ahmad 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.
- Results publication: PubMed 29030779Lorentzen 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.
- Results publication: PubMed 21775773Awonuga 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Adhesive Small Bowel Obstruction and Postoperative Abdominal Adhesions, run by Alessio Giordano.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact carlo bergamini, MD, General Surgeon (+393476360711, drcarlobergamini@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate of adhesive small bowel obstruction (ASBO) within 12 months (time frame: 12 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07078981, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.