Safety and Efficacy Study of a Hydrogel, Applied Following Removal of Myomas During Gynecologic Surgery, Administered for the Prevention/Reduction of Postoperative Adhesion Formation

Phase 1

Completed

• Conditions: Myoma

• Registration Number: NCT00562471
• Lead Sponsor: Angiotech Pharmaceuticals

Brief Summary

The purpose of this study was to determine whether the adhesion prevention gel was safe to use, and was effective for the prevention/reduction of adhesion formation that typically occurs following gynecological surgery to remove myomas

Detailed Description

Postoperative adhesions are a common medical complication of gynecologic and pelvic surgeries, and are frequently associated with chronic or recurrent pelvic pain, intestinal obstruction and infertility. This randomized, controlled, multicenter, clinical study was designed to evaluate the safety and performance of Adhibit™ Adhesion Prevention Gel versus the standard of care for the reduction of postoperative adhesions in subjects undergoing myomectomy via laparotomy or laparoscopy. Subjects were scheduled to return within 6-8 weeks after the initial surgical procedure. At that time, a second-look laparoscopy was performed for postoperative adhesion assessment. Adhesions were graded using a modified American Fertility Society (mAFS) scoring method.

Study Timeline

• Study Start: 2003-07
• Study Completion: 2005-01
• Status Verified: 2007-11
• Study First Submitted: 2007-11-20
• Study First Submitted QC: 2007-11-21
• Last Update Submitted: 2007-11-21
• Study First Posted: 2007-11-22
• Last Update Posted: 2007-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

Inclusion Criteria

Preoperatively, subjects must have had:

• Been scheduled for myomectomy via laparotomy or laparoscopy.
• Agreed to a second-look laparoscopic procedure to assess and lyse any adhesions formed at 6 to 8 weeks following myomectomy.
• Been >=18 years of age.
• Provided voluntary written informed consent.
• Been willing to comply with all aspects of the treatment and evaluation schedule.

Intra-operatively, subjects must have had:

• Had at least one 2 cm incision length on posterior uterine surface, which may include the fundal surface.

Exclusion Criteria

Preoperatively, subjects must not have had:

• Been pregnant.
• Had a pelvic malignancy.
• Had acute pelvic inflammatory disease.
• Had an immune compromised condition.
• Been a participant in another clinical research study which the investigator believed could interfere with the purpose of this study.
• Been given corticosteroids intra-operatively or during the course of the postoperative study follow up.

Intra-operatively, subjects must not have had:

• Had a pelvic malignancy.
• Had a pelvic or abdominal infection.
• Had acute pelvic inflammatory disease.
• Received any adhesion prevention adjuvants or barriers, or peritoneal instillates containing corticosteroids, NSAIDs, or Dextran.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
modified American Fertility Society (mAFS) score at the posterior uterus	6-8 weeks following primary myomectomy surgery

Secondary Outcome Measures

Name	Time	Method
adhesion extent and tenacity scores at the posterior uterus	6-8 weeks following primary myomectomy surgery

Trial Locations

Locations (6)

St. Joseph's Health Centre; 🇨🇦 Toronto, Ontario, Canada

Klinik für Minimal Invasive Chirurgie; 🇩🇪 Berlin, Germany

Universitätsklinikum Giessen; 🇩🇪 Giessen, Germany

Univ. Clinics of Schleswig-Holstein; 🇩🇪 Kiel, Germany

Bethesda Krankenhaus Wupperta; 🇩🇪 Wuppertal, Germany

St. Elizabeth Hospital; 🇳🇱 Curaçao, Netherlands Antilles