Opportunistic Salpingectomy During Bariatric Surgery for Ovarian Cancer Prevention

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorSt. Joseph's Healthcare Hamilton

About this trial

Ovarian cancer is a deadly disease that is hard to detect early and difficult to treat. Research shows that most ovarian cancers actually start in the fallopian tubes, not the ovaries. Removing the fallopian tubes (a procedure called salpingectomy) can lower the risk of ovarian cancer by about 80%. This procedure has no added risk to the patient, but does lead to sterilization and thus it is only offered to individuals who have completed child-bearing. Adding salpingectomy to another surgery that a patient is undergoing is called opportunistic salpingectomy and is already standard of practice in many gynecologic surgeries, such as hysterectomy. However, it is not yet commonly offered during weight-loss (bariatric) surgery, even though many patients having this surgery could benefit. This study will test whether it is practical and safe to offer fallopian tube removal during bariatric surgery at three hospitals in Canada. Patients who are eligible and interested will be invited to have their fallopian tubes removed at the same time as their planned weight-loss surgery. The research team will track whether the procedure can be completed successfully, whether there are any added complications, and how much extra time or resources are needed. The goal is to help make this cancer-prevention option available to more people.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals with fallopian tubes (no prior salpingectomy/salpingo-oophorectomy) who are undergoing an elective MBS and have completed child-bearing

Disqualifiers

unable to provide informed consent

Trial design

Design model

Single group

Treatments tested in this trial

  • Opportunistic salpingectomy at time of bariatric surgery

    Procedure/Surgery

    Opportunistic salpingectomy (fallopian tube removal) at time of planned elective bariatric surgery

Treatment groups

66 Participants
are divided into 1 treatment group
Group A: Opportunistic salpingectomy at bariatric surgeryExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants that successfully undergo opportunistic salpingectomy at time of their bariatric surgery

Time frame
From study commencement for 6 months

Secondary outcomes

1

Length of hospital stay

Safety outcome measure

Time frame
Length in days from admission to discharge from hospital, assessed up to 100 days
2

30-day hospital readmission rate

Safety outcome measure. As indicated by any return to hospital with an inpatient stay in the 30 days following discharge from their surgery.

Time frame
From procedure end to 30 days postoperatively
3

Blood transfusion

Safety outcome measure. As measured by any whole blood or blood parts administered to a patient's bloodstream

Time frame
From procedure start to 30 days postoperatively
4

Surgical site infection

Safety outcome measure. Defined as any infection that develops at the site of the surgical incision within 30 days that requires treatment.

Time frame
From procedure end to 30 days postoperatively

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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