A Controlled Randomized Multicenter Study to Assess the Safety and Performance of Adhibit™ Adhesion Prevention Gel in Myomectomy Surgery
18 Years
N/A
Female
Myoma
Trial Information
A Controlled Randomized Multicenter Study to Assess the Safety and Performance of Adhibit™ Adhesion Prevention Gel in Myomectomy Surgery
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Outcome Measure:
modified American Fertility Society (mAFS) score at the posterior uterus
Outcome Time Frame:
6-8 weeks following primary myomectomy surgery
Principal Investigator
Liselotte METTLE, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Univ. Clinics of Schleswig-Holstein
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
ADH-02-1
NCT ID:
NCT00562471
Start Date:
July 2003
Completion Date:
January 2005
Related Keywords:
- Myoma
- adhesions
- gynecologic surgery
- laparoscopy
- laparotomy
- polyethylene glycol
- hydrogel
- Adhesions following gynecologic surgery to remove myomas
- Tissue Adhesions
- Myoma
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