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

Phase 2

Completed

• Conditions: Intraperitoneal Adhesions
• Interventions: Biological: Anti-Adhesion Product

• Registration Number: NCT00512356
• Lead Sponsor: Baxter Healthcare Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-12
• Primary Completion: 2003-02-25
• Study Completion: 2003-04
• Study First Submitted: 2007-08-06
• Study First Submitted QC: 2007-08-06
• Study First Posted: 2007-08-07
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-03
• Last Update Posted: 2017-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Investigational product group	Anti-Adhesion Product	Anti-Adhesion Product was applied to the rectal stump and the incision line. Like in the control group, surgical measures to prevent adhesions were also taken, e.g. using minimum traumatizing surgical technique, using powder-free gloves.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of subjects with no adhesions
Extent and severity of adhesions around the rectal stump
Extent and severity of adhesions at the incision line
Incidence, extent and severity of adhesions at sites other than the rectal stump and incision line
Time to reach and free the rectal stump
Safety (laboratory evaluation, recording of adverse experiences)

Trial Locations

Locations (7)

Klinika Chirurgii Ogolnej Onkologicznej i Klatiki Piersiowej CSK WAM; 🇵🇱 Warsaw, Poland

Copenhagen University Hospital, Rigshospitalet Department of Gastroenterologic Surgery; 🇩🇰 Copenhagen, Denmark

Söder Sjukhuset, Department of Surgery; 🇸🇪 Stockholm, Sweden

Göteborg University, Department of Surgery, Colorectal Unit; 🇸🇪 Gothenburg, Sweden

Odense University Hospital, Surgical Gastroenterology Department; 🇩🇰 Odense, Denmark

Uddevalla Sjukhus, Kirurg Kliniken; 🇸🇪 Uddevalla, Sweden

Im. Marii Sklodowskiej-Curie, Centrum Onkologii-Instytut; 🇵🇱 Warsaw, Poland