Clinical trial NCT00512356: Efficacy and Safety Study of Anti-Adhesion Product in the Prevention of Intraperitoneal Adhesions
Official title: Study to Evaluate the Efficacy and Safety of Anti-Adhesion Product in the Prevention of Intraperitoneal Adhesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Intraperitoneal Adhesions
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2007-08-07
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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 Solution, Seprafilm® Membrane) during the first surgery
* Subjects with major fecal contamination needing an abdominal lavage during the first surgery

Primary outcomes:
measure: Incidence of adhesions around the rectal stump and/or incision line
Secondary outcomes:
measure: Number of subjects with no adhesions
measure: Extent and severity of adhesions around the rectal stump
measure: Extent and severity of adhesions at the incision line
measure: Incidence, extent and severity of adhesions at sites other than the rectal stump and incision line
measure: Time to reach and free the rectal stump
measure: Safety (laboratory evaluation, recording of adverse experiences)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital, Rigshospitalet Department of Gastroenterologic Surgery
city: Odense
country: Denmark
facility: Odense University Hospital, Surgical Gastroenterology Department
city: Warsaw
country: Poland
facility: Klinika Chirurgii Ogolnej Onkologicznej i Klatiki Piersiowej CSK WAM
city: Warsaw
country: Poland
facility: Im. Marii Sklodowskiej-Curie, Centrum Onkologii-Instytut
city: Gothenburg
country: Sweden
facility: Göteborg University, Department of Surgery, Colorectal Unit
city: Stockholm
country: Sweden
facility: Söder Sjukhuset, Department of Surgery
city: Uddevalla
country: Sweden
facility: Uddevalla Sjukhus, Kirurg Kliniken
Study officials:
affiliation: Baxter Healthcare Corporation
name: Baxter BioScience Investigator, MD
role: PRINCIPAL_INVESTIGATOR
References: