Infertility Clinical Trial
— VLocmyoOfficial title:
A Case Study to Evaluate Adhesion Risk in Fertility Patients' Post Laparoscopic Myomectomy Utilizing Vloc Suture.
Verified date | January 2017 |
Source | The Advanced Gynecologic Surgery Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 2014 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 42 Years |
Eligibility |
Inclusion Criteria: Premenopausal female ages 18-42 At least one fibroid 3 cm or greater requiring at least one uterine incision Preparing to undergo Laparoscopic myomectomy Exclusion Criteria: 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 |
Country | Name | City | State |
---|---|---|---|
United States | The Advanced gynecologic Surgery Institute | Naperville | Illinois |
Lead Sponsor | Collaborator |
---|---|
The Advanced Gynecologic Surgery Institute | Medtronic - MITG |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Following Laparoscopic myomectomy utilizing V-Loc 180 suture , Post operative adhesion formation will be measured by an independent reviewer at the time of second look laparoscopy utilizing a scoring tool. | The primary objective of this study is to evaluate post operative adhesion formation after using V-Locâ„¢ 180 during laparoscopic myomectomy. | 1 year | |
Secondary | The time required to close the incision as well as the ease of use to the surgeon will be measured utilizing a 1-5 ease of use scale. | The time required to close the incision as well as the ease of use to the surgeon will be measured . | 1 year |
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