a Study to Evaluate Adhesion Risk in Fertility Patients' Status Post Laparoscopic Myomectomy.

Withdrawn before enrolling · Not applicable

Conditions studied: Uterine Fibroids, Infertility

In brief

Premenopausal Women ages 18-42 will undergo a laparoscopic myomectomy. Prior to the myomectomy, adhesions will be assessed using a modified AFS scoring technique. All investigators will provide usual and customary care to research subjects during the first look laparoscopy. This includes the use of all standard practice anti-adhesive agents and heparinized irrigation fluids.V-Loc 180 suture will be utilized in all patients. All patients will then be evaluated by means of a second look laparoscopy (SLL) 6-12 weeks after the initial surgery and reevaluated via modified American Fertility Society scoring techniques. An independent reviewer will also score adhesions utilize a video recording made from the second look laparoscopic surgery. Patients will be contacted both 1 and 4 weeks post -op and assessed for complications. It is the expectation that patients will show no greater post-operative adhesion formation and a \<1% complication rate. Time and ease of suturing will also be evaluated. It is expected that the V-Loc suturing technique will show significantly reduced suturing time, be easier to use, and will be associated with minimal adhesions.

Key facts

Study ID

NCT01971060

Run by

The Advanced Gynecologic Surgery Institute

People needed

0

Starts

2013-08-01

Expected to finish

2014-10-01

Last updated by the study team

2017-01-25

Who can join

Age: 18 and older, up to 42. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Premenopausal female ages 18-42 At least one fibroid 3 cm or greater requiring at least one uterine incision Preparing to undergo Laparoscopic myomectomy

You may not qualify if…

• Post-menopausal or Pregnant
• Endometriosis involving the uterus
• Adhesions to the uterus found at the time of initial laparoscopy
• History of /Current cancer , except basal cell
• Surgery Contraindications, including cardiac or other major system issue
• Greater than 5 fibroids
• The patient has ever been treated with uterine artery embolization of the myoma or magnetic resonance imaging (MRI) or other guided ultrasonification of myoma(s).
• The patient has any medical condition that might interfere with the safety of surgery and the second look laparoscopy, such as active intra-abdominal infection or abscess
• BMI > 34

Where it is running

• The Advanced gynecologic Surgery Institute — Naperville, Illinois, United States

Full record on ClinicalTrials.gov

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