Clinical trial NCT00562471: Safety and Efficacy Study of a Hydrogel, Applied Following Removal of Myomas During Gynecologic Surgery, Administered for the Prevention/Reduction of Postoperative Adhesion Formation
Official title: A Controlled Randomized Multicenter Study to Assess the Safety and Performance of Adhibit™ Adhesion Prevention Gel in Myomectomy Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Myoma
Keywords: adhesions
gynecologic surgery
laparoscopy
laparotomy
polyethylene glycol
hydrogel
Adhesions following gynecologic surgery to remove myomas
Lead sponsor: Angiotech Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-11-22
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: modified American Fertility Society (mAFS) score at the posterior uterus
timeFrame: 6-8 weeks following primary myomectomy surgery
Secondary outcomes:
measure: adhesion extent and tenacity scores at the posterior uterus
timeFrame: 6-8 weeks following primary myomectomy surgery
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Joseph's Health Centre
state: Ontario
city: Berlin
country: Germany
facility: Klinik für Minimal Invasive Chirurgie
city: Giessen
country: Germany
facility: Universitätsklinikum Giessen
city: Kiel
country: Germany
facility: Univ. Clinics of Schleswig-Holstein
city: Wuppertal
country: Germany
facility: Bethesda Krankenhaus Wupperta
city: Curaçao
country: Netherlands Antilles
facility: St. Elizabeth Hospital
Study officials:
affiliation: Univ. Clinics of Schleswig-Holstein
name: Liselotte METTLE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mettler L, Hucke J, Bojahr B, Tinneberg HR, Leyland N, Avelar R. A safety and efficacy study of a resorbable hydrogel for reduction of post-operative adhesions following myomectomy. Hum Reprod. 2008 May;23(5):1093-100. doi: 10.1093/humrep/den080. Epub 2008 Mar 17.