Myoma
Conditions
Keywords
adhesions, gynecologic surgery, laparoscopy, laparotomy, polyethylene glycol, hydrogel, Adhesions following gynecologic surgery to remove myomas
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.
Interventions
OTHERAdhibit Adhesion Prevention Gel
A resorbable hydrogel, which adheres to itself and the tissues it contacts, is approved for use in sealing vascular reconstructions. The hydrogel is formed when two synthetic derivatized polyethylene glycol (PEG) polymers are mixed together and applied to tissue. Using a gas-assisted delivery device, the hydrogel is sprayed over all myomectomy suture lines and all surgically treated areas during the myomectomy surgery. The hydrogel is totally resorbed within 30 days post-application.
OTHERStandard of Care Comparator
standard of care for post-operative adhesion prevention included irrigation of tissues and lavage of all fluids with Ringers Lactate solution following surgery and 300 to 500mL of solultion left in the pelvic cavity immediately prior to wound closure
Sponsors
Angiotech Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| modified American Fertility Society (mAFS) score at the posterior uterus | 6-8 weeks following primary myomectomy surgery |
Secondary
| Measure | Time frame |
|---|---|
| adhesion extent and tenacity scores at the posterior uterus | 6-8 weeks following primary myomectomy surgery |
Countries
Canada, Germany, Netherlands Antilles
Outcome results
None listed