Surgery
Conditions
Keywords
abdominal surgery, pelvic surgery, Opportunistic Salpingectomy, ovarian cancer prevention, 24-006, Memorial Sloan Kettering Cancer Center
Brief summary
The purpose of this study is to find out how many participants are interested in a surgical preventive procedure after watching an educational video. Before and after watching the video, participants will complete questionnaires in the clinic.
Interventions
BEHAVIORALEducational Module
Part 1 consists of an education module with premodule and postmodule assessment questionnaires.
PROCEDURESalpingectomy
Part 2 consists of incorporating opportunistic salpingectomy /OS into non-gynecologic surgery
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Part I * Age ≥45 years * Scheduled visit with a nongynecologic surgeon * Female or assigned female at birth Part II * Age ≥45 years * At least one in situ fallopian tube * No desire or plan to have children in the future * Average risk of developing ovarian cancer ° Note: Average risk patients are defined as patients with no known genetic risk factor for developing ovarian cancer. Patients who, after obtaining family history, are suspected to have a hereditary ovarian cancer syndrome but have not yet been tested, will be referred for genetic evaluation. * Planned nongynecologic, intraabdominal, or pelvic surgery * Deemed to be a suitable candidate by gynecologic surgeon and primary nongynecologic surgeon (for example, on the basis of surgical history and current malignancy status) * Approved and signed informed consent
Exclusion criteria
Part I * Not fluent in English or Spanish ° If there is a non-english or non-spanish speaking participant who is a strong candidate and meets all other criteria for Part 2, they are able to go directly onto Part 2 without completing Part 1. (Please see additional details in section 4.1 and 7.0.) * Known inherited ovarian cancer susceptibility Part II * Personal history of a gynecologic malignancy * Carrier of a hereditary breast or ovarian cancer variant (e.g., BRCA1, BRCA2, BRIP1, PALB2, RAD51C, RAD51D, MLH1, MSH2, MSH6, PMS2) * Suspicious ovarian, fallopian tube, or uterine lesion on preoperative imaging * Previous bilateral salpingectomy or bilateral salpingo-oophorectomy * Presence of ESSURE, or other tubal-implanted birth control at the time of surgery * Current pregnancy * Emergent procedure or emergency procedure that has to be completed within 24 hours where clinical consent occurs in the inpatient setting or where the patient's immediate well-being is in danger or condition may be life threatening * Primary surgeon anticipates that OS will add significant time (\>30-40min) to the planned procedure. * Inability to access the pelvis (ex., patient prone/lateral position) during the planned procedure. * Known history of pelvic fibrosis or significant adhesions. * Procedures with palliative intent only
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Opportunistic Salpingectomy/OS after completion of educational module | up to 2 years | Evaluate the acceptance of Opportunistic Salpingectomy/OS among nongynecologic surgical patients after completion of an educational module |
Countries
United States
Contacts
CONTACTKara Long Roche, MD
CONTACTMartin Weiser, MD
PRINCIPAL_INVESTIGATORKara Long Roche, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed