Laparoscopic Hysterectomy
Conditions
Keywords
Hysterectomy, Laparoscopic hysterectomy, minimally invasive hysterectomy
Brief summary
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.
Detailed description
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.
Interventions
DEVICEZip-stitch(R)
Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy
DEVICEReference suture
Standard suture for vaginal cuff closure during laparoscopic hysterectomy
Sponsors
ZSX Medical LLC
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1\. Provision of signed and dated Informed Consent Form 2. Stated willingness to comply with all study procedures, including participation in follow-up visits and telephonic follow-up 3. Female 18 years and older 5. Indicated for Laparoscopic Hysterectomy (includes Total Laparoscopic Hysterectomy, Laparoscopic Assisted Vaginal Hysterectomy, or robotic assisted vaginal hysterectomy)
Exclusion criteria
1. History of Human Immunodeficiency Virus (HIV) 2. History of Hepatitis C 3. History of diabetes that, in the opinion of the investigator, may delay healing 4. Current use of systemic corticosteroids 5. Active infection of genitals, vagina, cervix, uterus or urinary tract 6. Active bacteremia, sepsis or other active systemic infection 7. Presence of Sexually Transmitted Infection (STI) 8. Evidence of pelvic inflammatory disease (PID) 9. Known clotting defects or bleeding disorders 10. Hemoglobin \< 8 g/dL 11. Metastatic disease 12. On anticoagulant therapy 13. Participation in another interventional trial 14. Pregnancy 15. Abnormal Papanicolaou test (PAP) results that have not been fully evaluated, or in the opinion of the investigator may indicate abnormal vaginal cuff healing 16. Co-morbidities that, in the opinion of the investigator, may indicate risk of abnormal vaginal cuff healing 17. Intra-operative: Bowel injury during laparoscopic hysterectomy procedure prior to attempted cuff closure 18. Intra-operative: Bladder injury during laparoscopic hysterectomy procedure prior to attempted cuff closure 19. Intra-operative: Cases in which surgeon cannot identify adequate tissue along the cuff to apply suture laparoscopically 20. Intra-operative: Cases requiring conversion to laparotomy prior to study intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal Cuff Dehiscence Rate | This will be evaluated through six-weeks post-operative. | 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. |
| Number of Participants With Implant Passing Through Six Weeks | This will be evaluated through six weeks post operative. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful Vaginal Cuff Closure | Performed intra-operatively and at one week, six weeks, and six months after surgery | 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). |
| Number of Participants With Healed Vaginal Cuffs | Performed at one week, six weeks, and six months after surgery | 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. |
| Comparison of Number of Participants With Implant Passing - Test to Reference | Evaluated at six weeks and six months post-operative | Percentage of subjects experiencing implant passing will be compared between test and reference groups. |
| Percentage of Participants With Implant Passing Events Determined to Impact Patient Safety | Evaluated through six-month follow-up | 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. |
| Comparison of Incidence of Adverse Events - Test to Reference | Evaluated through six-month follow-up | Adverse events and serious adverse events will be tabulated for both the test and reference groups. |
| Comparison of Change in Dyspareunia | Evaluated through twelve-month follow-up | 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". |
| Comparison of Change in Pain | Six-months post-operative and again at 12 months post-operative | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPaul Gilman, MD
Main Line Health
Participant flow
Recruitment details
This study was designed as a staged study. After completion of the first stage of 23 subjects, the study was stopped in preparation for a subsequent study.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 49 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 64 Inches |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 0 Participants |
| Weight | 181 Pounds |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 10 |
| other Total, other adverse events | 4 / 13 | 4 / 10 |
| serious Total, serious adverse events | 1 / 13 | 0 / 10 |
Outcome results
None listed