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

This study is currently recruiting participants.
Verified July 2013 by The Advanced Gynecologic Surgery Institute
Sponsor:
Collaborator:
Covidien
Information provided by (Responsible Party):
Charles E Miller MD, The Advanced Gynecologic Surgery Institute
ClinicalTrials.gov Identifier:
NCT01971060
First received: September 24, 2013
Last updated: October 26, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Uterine Fibroids
Infertility
Device: surgery utilizing V-Loc suture

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Case Study to Evaluate Adhesion Risk in Fertility Patients' Post Laparoscopic Myomectomy Utilizing Vloc Suture.

Resource links provided by NLM:


Further study details as provided by The Advanced Gynecologic Surgery Institute:

Primary Outcome Measures:
  • 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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The primary objective of this study is to evaluate post operative adhesion formation after using V-Loc™ 180 during laparoscopic myomectomy.


Secondary Outcome Measures:
  • 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. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    The time required to close the incision as well as the ease of use to the surgeon will be measured .


Estimated Enrollment: 10
Study Start Date: August 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: V-Loc suture
Laparoscopic surgery utilizing V-Loc suture
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.
Other Names:
  • Covidien
  • V-Loc

Detailed Description:

This is a post-market, controlled, single-center study to evaluate V-Loc suture. 10 subjects will be included in this study. Premenopausal women ages 18-42 will undergo a laparoscopic myomectomy. Adhesion scoring will be done prior to the myomectomy using a modified American Fertility Society scoring technique. V-loc 180 suture will be utilized in all patients for closure of all uterine defects. All patients will then be evaluated by means of a second look laparoscopy (SLL) 6-12 weeks after the initial surgery and evaluated via modified American Fertility Society scoring techniques.

An independent reviewer will also score adhesions utilizing video recordings made from the second look laparoscopic surgery , using the same scoring techniques employed by the PI..

Patients will undergo routine preoperative blood tests in accordance with the Primary Investigators' usual standard of practice. All patients who meet the inclusion criteria will be considered. Patients will be consented prior to entry into the operating room. Surgical time will be measured from start of procedure, start of myomectomy, and start and finish time of each individual uterine closure. 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

. Physicians will be surveyed on ease of use and any problems that occur with V-Loc suture.

All patients will be treated with post-operative antibiotics per the Primary Investigator's usual standard of care. Patients will be contacted both one and 4 weeks post surgery and evaluated for complications using a phone survey for pain and bowel functioning. The patient will also have a standard post operative exam with the physician 4-6 weeks post-operatively. A second look laparoscopy will be performed 6-12 weeks following the initial myomectomy. Adhesions will be evaluated using a modified American Fertility Society evaluation tool. Any adhesions seen at the time of SLL will be treated using the physician's preferred method of adhesiolysis. A recording will be obtained of the second look laparoscopy and will be reviewed and scored by an independent reviewer as to the level of adhesions seen .

  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01971060

Contacts
Contact: Mary Johnston, RN/BSN 630-364-1112 mjohnston@charlesemillermd.org
Contact: Lisa Maki 630-364-1119 lmaki@charlesemillermd.org

Locations
United States, Illinois
The Advanced gynecologic Surgery Institute Recruiting
Naperville, Illinois, United States, 60540
Contact: Mary Johnston, RN/BSN    630-364-1112    mjohnston@charlesemillermd.org   
Contact: Lisa Maki    630-364-1119    lmaki@charlesemillermd.org   
Principal Investigator: Charles E Miller, MD         
Sub-Investigator: Aarathi Cholkeri, MD         
Sponsors and Collaborators
The Advanced Gynecologic Surgery Institute
Covidien
Investigators
Principal Investigator: Charles E Miller, MD Advanced GSI
  More Information

No publications provided

Responsible Party: Charles E Miller MD, President, The Advanced Gynecologic Surgery Institute
ClinicalTrials.gov Identifier: NCT01971060     History of Changes
Other Study ID Numbers: VLocmyo
Study First Received: September 24, 2013
Last Updated: October 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by The Advanced Gynecologic Surgery Institute:
uterine fibroids
barbed suture
infertility
adhesions

Additional relevant MeSH terms:
Tissue Adhesions
Infertility
Leiomyoma
Myofibroma
Cicatrix
Fibrosis
Pathologic Processes
Genital Diseases, Male
Genital Diseases, Female
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on April 17, 2014