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

NCT01971060 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-01-25

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

surgery utilizing V-Loc suture

V-Loc suture will be utilized in the repair of the uterus following removal of fibroid tumors. a second look laparoscopy will be done on all subjects to evaluate scar tissue formation.

Sponsors & Collaborators

  • Medtronic - MITG

    collaborator INDUSTRY

  • The Advanced Gynecologic Surgery Institute

    lead OTHER

Principal Investigators

  • Charles E Miller, MD · Advanced GSI

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01971060 on ClinicalTrials.gov