The primary objective of this study is to evaluate the safety and efficacy of the Zip-stitch® Vaginal Cuff Closure System. This will be primarily done by measuring the frequency of implant passing following system use. Also assessed will be relevant safety and efficacy endpoints as compared to a two-to-one reference group.
This study is a prospective, blinded, randomized, controlled study to assess the safety and efficacy of the Zip stitch® System in maintaining vaginal cuff closure following minimally-invasive hysterectomy. Participating subjects will be randomized and evaluated for implant passing, successful cuff closure, healing, adverse events, dyspareunia, and pain. Blinded follow-up will involve in-person visits at one week and six weeks. There will be additional unblinded follow-up in person at six months post-operatively and by telephone at 12 months post operatively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
23
Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy
Standard suture for vaginal cuff closure during laparoscopic hysterectomy
Northwestern University
Chicago, Illinois, United States
Unified Women's Clinical Research
Winston-Salem, North Carolina, United States
Lankenau Hospital
Wynnewood, Pennsylvania, United States
Tidewater Clinical Research
Virginia Beach, Virginia, United States
Vaginal Cuff Dehiscence Rate
Safety: The primary safety endpoint in this study is frequency of vaginal cuff dehiscence. Vaginal cuff dehiscence is defined as rupture of the surgical wound requiring surgical re-intervention.
Time frame: This will be evaluated through six-weeks post-operative.
Number of Participants With Implant Passing Through Six Weeks
Efficacy: The primary efficacy endpoint for this study is frequency of implant passing following cuff closure. This endpoint is based upon the rate of spontaneous implant passing events. A single event may be pieces of one or more clips or sutures being spontaneously passed by the patient (i.e., not removed by medical staff). For the primary endpoint, only passing of clips will be counted, but for secondary endpoint, clips or sutures will be counted. When implant passing was reported, subjects were asked to collect and provide passed implants, and an in-person evaluation was performed. This involved a visual cuff closure and healing assessment.
Time frame: This will be evaluated through six weeks post operative.
Number of Participants With Successful Vaginal Cuff Closure
Cuff closure was assessed by a qualified independent blinded evaluator at zero, one, and six weeks, as well as at six months, according to a standardized protocol. Surgeon visual assessment graded vaginal cuffs as closed (Y) or not closed (N).
Time frame: Performed intra-operatively and at one week, six weeks, and six months after surgery
Number of Participants With Healed Vaginal Cuffs
Vaginal cuff healing was visually assessed by a blinded evaluator at one week, six weeks, and six months. Evaluator visual assessment graded vaginal cuffs as healed (Y) or not healed (N), or the evaluator indicated that it was not possible to determine.
Time frame: Performed at one week, six weeks, and six months after surgery
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Mon Health Medical Center
Morgantown, West Virginia, United States
Comparison of Number of Participants With Implant Passing - Test to Reference
Percentage of subjects experiencing implant passing will be compared between test and reference groups.
Time frame: Evaluated at six weeks and six months post-operative
Percentage of Participants With Implant Passing Events Determined to Impact Patient Safety
Each reported implant passing event will be evaluated for association with adverse events. Compared as a percentage of patients in the test vs. reference groups.
Time frame: Evaluated through six-month follow-up
Comparison of Incidence of Adverse Events - Test to Reference
Adverse events and serious adverse events will be tabulated for both the test and reference groups.
Time frame: Evaluated through six-month follow-up
Comparison of Change in Dyspareunia
Dyspareunia will be pre-operatively baselined and assessed at each follow-up timepoint, including any unexpected visits, using the sexual pain and discomfort domain (four questions) from the validated Female Sexual Function Index (FSFI). Individual success is defined as non-increase in dyspareunia from baseline to six months. Data analyzed "as treated".
Time frame: Evaluated through twelve-month follow-up
Comparison of Change in Pain
Patient pain will be pre-operatively baselined and assessed at each follow-up timepoint, including any unexpected visits, using a validated 11-point numerical rating scale (no pain: 0 - the most pain: 10). Individual success is defined as non-increase in pain between baseline and six months. Fisher's Exact Test will be used to compare this measure between Test and Reference groups.
Time frame: Six-months post-operative and again at 12 months post-operative