CompletedPhase 2

Efficacy and Safety Study of Anti-Adhesion Product in the Prevention of Intraperitoneal Adhesions

Denmark, Poland, Sweden46 participantsStarted 2000-12

Plain-language summary

The objective of this study was to evaluate the efficacy of the Anti-Adhesion Product (AAP) in preventing or reducing post-operative adhesion formation and re-formation in a subject population having abdominal surgery and being left with a rectal stump and a temporary stoma from a first procedure and scheduled for a laparoscopy/ laparotomy as a second procedure in the normal treatment of the subjects' disease. In both study groups, surgical measures to prevent adhesions were taken, e.g. using minimum traumatizing surgical technique, using powder-free gloves. In the investigational product group, AAP was applied to the rectal stump and the incision line while no specific additional treatment was applied in the control group. The surgeon assessed preexisting adhesions during the first surgery. Newly developed and re-formed adhesions were evaluated during the second surgery by a surgeon or assistant who did not know the result of randomization. The safety of the study drug was also monitored.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Written informed consent obtained from the subject or the subject's legally authorized representative prior to study entry * Male or female subjects \> 18 years of age * Subjects undergoing abdominal surgery with the possibility that a rectal stump would remain due to one or more of the following reasons: inflammatory bowel diseases, neoplasm, colon diverticulitis, colonic obstruction, colon polyposis, peritoneal trauma, fistula, incontinence, or other reasons * Subjects for whom a second abdominal surgery is planned within approximately eight months of the first surgical procedure. Exclusion Criteria: Pre operative: * Pregnancy and lactation period * Subjects concurrently participating in another clinical trial with a drug or a device * Subjects who have participated in a clinical trial with a drug or a device within 30 days prior to this study * Subjects who have had abdominal/pelvic surgery within six months prior to this study * Subjects who have received or will receive (approximately within the next eight months) abdominal/pelvic irradiation Intra operative: * Subjects with peritonitis * Subjects with gastrointestinal metastatic cancer, or cancer growing per continuitatem into surrounding tissues * Subjects treated with hemostatic agents (e.g. fibrin sealant, collagen, oxidized cellulose) during the first surgery * Subjects treated with adhesion prevention agents other than the Anti-Adhesion Product (AAP) (e.g. Intergel® Adhesion Prevention S…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of adhesions around the rectal stump and/or incision line

Trial details

NCT IDNCT00512356

SponsorBaxter Healthcare Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2003-02-25

View on ClinicalTrials.gov More Intraperitoneal Adhesions trials