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 (V-LOC barbed suture).
This is a prospective, blinded, randomized, controlled study to assess the safety and efficacy of the Zip-stitch™ System in maintaining vaginal cuff closure following laparoscopic 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, six weeks, and six months. There will be an additional unblinded follow-up by telephone at 12 months post operatively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
2
The assigned intervention is used to close the cuff following colpotomy.
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
Primary Efficacy Endpoint - Number of Participants With Implant Passing
Frequency of implant passing following laparoscopic vaginal cuff closure within six weeks
Time frame: Six-weeks post-operative
Primary Safety Endpoint - Number of Participants With Vaginal Cuff Dehiscence
Frequency of Vaginal Cuff Dehiscence following laparoscopic vaginal cuff closure.
Time frame: Six-weeks post-operative
Number of Participants With Successful Vaginal Cuff Closure
Binary, visual surgeon cuff closure evaluation
Time frame: Performed at one week, six weeks, and six months after surgery; reported here at six weeks
Number of Participants With Vaginal Cuff Healing
Binary, visual surgeon cuff healing evaluation
Time frame: Performed at one week, six weeks, and six months after surgery; reported here at six weeks
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 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 after one week, six week, six month, and twelve month follow-up
Comparison of Incidence of Adverse Events - Test to Reference
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Adverse events and serious adverse events will be tabulated for both the test and reference groups.
Time frame: Evaluated after one week, six week, six month, and twelve month follow-up; reported here for all time
Number of Participants With Non-increase in Dyspareunia at Follow-up
Non-increase in reported individual subject dyspareunia from baseline to follow-up will be compared (test versus reference group) using the relevant sexual discomfort module of the Female Sexual Function Index (FSFI). The FSFI is a validated metric of female sexual function, where lower scores indicate poor sexual function. Non-increase in sexual discomfort will be compared between test and control groups.
Time frame: Six-months post-operative and again at 12 months post-operative
Number of Participants With Non-increase in Pain at Follow-up
Non-increase in reported individual subject pain from baseline to follow-up will be compared (test versus reference group) using an 11-point Numerical Rating Scale, where 0 indicates no pain, and 10 indicates maximum possible pain.
Time frame: Six-months post-operative and again at 12 months post-operative; count is number of subjects with non-increase