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

NCT01971060 | Withdrawn DMC

• 1 other identifier: VLocmyo
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Uterine Fibroids; Infertility

Keywords

uterine fibroids; barbed suture; infertility; adhesions

Outcome Measures

Primary Outcomes (1)

• 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-Loc™ 180 during laparoscopic myomectomy.

  1 year

Secondary Outcomes (1)

• 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.

  1 year

Study Arms (1)

V-Loc suture

EXPERIMENTAL

Laparoscopic surgery utilizing V-Loc suture

Device: surgery utilizing V-Loc suture

Interventions

surgery utilizing V-Loc suture DEVICE

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.

Also known as: Covidien, V-Loc

V-Loc suture

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• The Advanced Gynecologic Surgery Institute: lead
• Medtronic - MITG: collaborator

Study Sites (1)

The Advanced gynecologic Surgery Institute

Naperville, Illinois, 60540, United States

Location

MeSH Terms

Conditions

Leiomyoma; Infertility; Tissue Adhesions

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Genital Diseases; Urogenital Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Charles E Miller, MD

  Advanced GSI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: October 28, 2013
• Study Start: August 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: January 25, 2017

Record last verified: 2017-01

Locations

US (1)