Adhesive Peritoneal BandNCT06859307
Intra-Abdominal Instillation Of Fresh Frozen Plasma Versus Corticosteroids In Prevention Of Recurrent Attacks Of Adhesive Intestinal Obstruction: A 2 Years' Experience Clinical Study
A study testing intra-abdominal instillation of corticosteroids and intra-abdominal instillation of fresh frozen plasma in people with Adhesive Peritoneal Band, run by Zagazig University at 2 sites in Egypt.
Trial summary
Adhesive Intestinal obstruction is an inevitable complication of abdominal surgery with significant morbidity associated with poor quality of life and predispose to repeated hospitalization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adhesive Peritoneal Band
- What is being tested?
- intra-abdominal instillation of corticosteroids and intra-abdominal instillation of fresh frozen plasma
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Mar 2025to 1 Mar 2027
- Phase
- Interventional
- 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
Who may be able to join
- Patients with attacks of adhesive intestinal obstruction
Who cannot join
- Associated abdominal malignancy, patients with adhesive IO who respond to conservative treatment.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of Medicine
Zagazig, Sharqia Province, 44519
Zagazig University Hospitals
Zagazig, zagazig, 44519
About this study
Adhesive Intestinal obstruction is an inevitable complication of abdominal surgery with significant morbidity associated with poor quality of life and predispose to repeated hospitalization. Most of them (73% - 90%) can be managed conservatively.Despite advances in surgery, 15to 30% require surgical intervention primarily or due to failure of conservative management. Because of the nature of the disease recurrence has been estimated to be 30%.Many attempts to prevent formation of postoperative adhesions have been tried. In this trial, we will study the effect of corticosteroids and FFP in prevention of adhesive small bowel obstruction recurrence for follow up of 2 years duration.
- Conditions
- Adhesive Peritoneal Band
- Being tested
- intra-abdominal instillation of corticosteroids, intra-abdominal instillation of fresh frozen plasma
- Keywords
- adhesions, corticosteroids, fresh frozen plasma
- Medical subject headings
- Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-abdominal instillation of corticosteroidsProcedure or surgery
after adhesiolysis, peritoneal lavage with diluted corticosteroids will be instillated intra-abdominally
intra-abdominal instillation of fresh frozen plasmaProcedure or surgery
after adhesiolysis, peritoneal lavage with diluted FFP will be instillated intra-abdominally
| Study group | Role | What they receive |
|---|---|---|
| group I: adhesive intestinal obstruction | Active comparator | Not described Receives: Procedure: intra-abdominal instillation of corticosteroids |
| group II: adhesive intestinal obstruction | Active comparator | Not described Receives: Procedure: intra-abdominal instillation of fresh frozen plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
intestinal obstruction
intestinal obstruction is detected if the patient had constipation and vomiting with ultrasound showing dilated bowel and to and fro movement and the plain erect shows multiple air fluid levels
Measured: from 1 day to 2 years post operative
bowel injury
bowel injury will be detected if intestinal contents present in the drain or wound
Measured: from 1 day to 2 years post operative
wound infection
wound infection is detected if there is pus in the drain or wound
Measured: from 1 day to 2 weeks post-operative
Secondary outcomes (2)
age
age will be recorded in years
Measured: from 2 to 3 days before surgery
sex
The sex of the patient will be recorded (male or female)
Measured: from 2 to 3 days before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start1 Mar 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive Peritoneal BandStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Reham Zakaria Mohamed Ahmed, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859307
- Sponsor's protocol ID
- #1109\25-Feb-2025
- Status last verified
- Feb 2025
- First submitted
- 27 Feb 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: data will be available on demand by contacting the principle investigator
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-Abdominal Instillation Of Fresh Frozen Plasma Versus Corticosteroids In Prevention Of Recurrent Attacks Of Adhesive Intestinal Obstruction: A 2 Years' Experience Clinical Study
- ClinicalTrials.gov ID
- NCT06859307
- Acronym / sponsor ID
- #1109\25-Feb-2025
- Conditions
- Adhesive Peritoneal Band
- Keywords
- adhesions, corticosteroids, fresh frozen plasma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 5 Mar 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.
Adhesive Intestinal obstruction is an inevitable complication of abdominal surgery with significant morbidity associated with poor quality of life and predispose to repeated hospitalization. Most of them (73% - 90%) can be managed conservatively.Despite advances in surgery, 15to 30% require surgical intervention primarily or due to failure of conservative management. Because of the nature of the disease recurrence has been estimated to be 30%.Many attempts to prevent formation of postoperative adhesions have been tried. In this trial, we will study the effect of corticosteroids and FFP in prevention of adhesive small bowel obstruction recurrence for follow up of 2 years duration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group I: adhesive intestinal obstruction | Active comparator | Procedure: intra-abdominal instillation of corticosteroids |
| group II: adhesive intestinal obstruction | Active comparator | Procedure: intra-abdominal instillation of fresh frozen plasma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with attacks of adhesive intestinal obstruction
Key exclusion criteria (1 listed)
- Associated abdominal malignancy, patients with adhesive IO who respond to conservative treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intra-abdominal instillation of corticosteroidsafter adhesiolysis, peritoneal lavage with diluted corticosteroids will be instillated intra-abdominally | Procedure or surgery | group I: adhesive intestinal obstruction |
| intra-abdominal instillation of fresh frozen plasmaafter adhesiolysis, peritoneal lavage with diluted FFP will be instillated intra-abdominally | Procedure or surgery | group II: adhesive intestinal obstruction |
Primary outcome
intestinal obstruction
Time frame: from 1 day to 2 years post operative
intestinal obstruction is detected if the patient had constipation and vomiting with ultrasound showing dilated bowel and to and fro movement and the plain erect shows multiple air fluid levels
bowel injury
Time frame: from 1 day to 2 years post operative
bowel injury will be detected if intestinal contents present in the drain or wound
wound infection
Time frame: from 1 day to 2 weeks post-operative
wound infection is detected if there is pus in the drain or wound
2 secondary outcomes
age
Time frame: from 2 to 3 days before surgery
sex
Time frame: from 2 to 3 days before 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 14 Aug 2025.
- Individual participant dataSharing planned: Undecided. data will be available on demand by contacting the principle investigator
Related trials for Adhesive Peritoneal Band
Not yet recruitingObservational study
Adhesion Prevention in ASBO Surgery Using 4DryField® PH
Adhesive Small Bowel Obstruction, Postoperative Abdominal Adhesions
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intra-abdominal instillation of corticosteroids and intra-abdominal instillation of fresh frozen plasma in people with Adhesive Peritoneal Band, run by Zagazig University at 2 sites in Egypt.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intestinal obstruction (time frame: from 1 day to 2 years post operative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2025.