Preventing Ovarian Cancer Through Opportunistic Salpingectomy at the Time of Laparoscopic Cholecystectomy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age35+
SponsorUniversity of British Columbia

About this trial

This study aims to evaluate the feasibility, safety, and cost-effectiveness of opportunistic salpingectomy (OS-the removal of the fallopian tubes) at the time of laparoscopic cholecystectomy (the removal of the gallbladder) to prevent ovarian cancer. Ovarian cancer is the fifth leading cause of cancer-related mortality in females in Canada. OS can prevent the most common and lethal type of ovarian cancer, high-grade serous carcinoma (HGSC). OS during gynecologic surgery (hysterectomy or instead of tubal ligation) is safe and effective. However, rates of hysterectomies and tubal sterilization are decreasing. This research team aims to extend the prevention of ovarian cancer by expanding to offer OS during other surgeries in the abdomen, when patients are already undergoing a surgical procedure. This study will examine: 1) the feasibility of OS at the time of laparoscopic cholecystectomy; 2) the safety of OS at the time of laparoscopic cholecystectomy; 3) any health services consequences of offering OBS during laparoscopic cholecystectomy.

The hypothesis is that OS at the time of laparoscopic cholecystectomy is a feasible, safe, and cost-effective primary prevention strategy for ovarian cancer. It is also hypothesized that there will be 10-20 minutes of additional operating room time for completing OS, and that integrating the identified partners and knowledge users, as well as adding relevant knowledge users as the project progresses, will affect the rapid mobilization of our findings.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals with fallopian tubes who are undergoing lap chole and have more than 24 hours from surgeon consult to surgery, regardless of menopausal status

Age of 35 years and older

Patient must be able to give oral and written informed consent

Premenopausal patients will be included but will be counseled regarding their fertility

Disqualifiers

Less than 24 hours available from surgeon consult to surgery

Individuals with a desire for a future pregnancy

Previously had a salpingectomy or salpingo-oophorectomy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bilateral salpingectomy

    Procedure/Surgery

    Removal of both fallopian tubes.

  • Laparoscopic cholecystectomy

    Procedure/Surgery

    Removing the gallbladder as indicated by the attending surgeon

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: Opportunistic salpingectomyExperimental treatment 2 interventions
Group B: Laparoscopic cholecystectomy onlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility: consent to opportunistic salpingectomy

The percentage of patients who consented to opportunistic bilateral salpingectomy and went on to successfully have both fallopian tubes removed during their laparoscopic cholecystectomy

Time frame
During the surgical intervention (~2 hours for surgical intervention)
2

Safety: Length of stay

Number of days hospitalized from admission time to discharge time

Time frame
Within 30 days after surgery
3

Safety: 30- day hospital readmission rate

Indicated by any return to hospital with an inpatient stay in the 30 days following discharge from the surgery

Time frame
Within 30 days following discharge from the surgery
4

Safety: Blood transfusion rate

Indicates whether a blood transfusion was required or any other hemostatic agents were used, as measured by any procedure in which whole blood or blood parts are put into a patient's bloodstream through a vein

Time frame
During surgery up to 30 days post-surgery

Secondary outcomes

Other outcomes

Sponsors and contacts

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University of British Columbia

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Canadian Cancer Society (CCS)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: