Safety and Efficacy Study of a Hydrogel, Applied Following Removal of Myomas During Gynecologic S… (NCT00562471) | Clinical Trial Compass
CompletedPhase 1/2
Safety and Efficacy Study of a Hydrogel, Applied Following Removal of Myomas During Gynecologic Surgery, Administered for the Prevention/Reduction of Postoperative Adhesion Formation
Canada, Germany76 participantsStarted 2003-07
Plain-language 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
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
modified American Fertility Society (mAFS) score at the posterior uterus
Timeframe: 6-8 weeks following primary myomectomy surgery