Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05300711 |
| Other study ID # |
H22-003399 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 20, 2022 |
| Est. completion date |
March 2026 |
Study information
| Verified date |
February 2024 |
| Source |
University of British Columbia |
| Contact |
Gillian Hanley, PhD |
| Phone |
778-888-5822 |
| Email |
Gillian.Hanley[@]vch.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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 colorectal surgery to
prevent ovarian cancer. Ovarian cancer is the fifth 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 pelvis where fallopian tubes
are accessible, beginning with colorectal surgery. This study will examine: 1) the
feasibility of OS at the time of colorectal surgery; 2) the safety of OS at the time of
colorectal surgery; 3) the cost-effectiveness of OS at the time of colorectal surgery.
The hypothesis is that OS will be well accepted by individuals with fallopian tubes
undergoing colorectal surgery, and that the vast majority (around 90 percent) of attempts to
remove both fallopian tubes will be successful. It is expected that there will be 10-20
minutes additional operating room time for completing OS and that there will be no increased
risk of complications when OS is included in a colorectal surgery. The researchers also
hypothesize that OS at the time of colorectal surgery will be cost-effective because of the
reduced number of ovarian cancer cases and associated treatment costs.
Description:
Research design:
120 eligible participants will be enrolled and consented to undergo OS at the time of
colorectal surgery. As a control group, 120 participants undergoing colorectal surgery
without OS will be included. When eligible participants decline OS, they will be approached
to participate as a control, and once 120 participants have consented to OS, participants
will be enrolled as controls until there are 120 patients in the control group.
Methods and analysis:
The research coordinator will contact participants to consent them to undergo OS or to
participate as a control participant at a preoperative visit prior to their colorectal
surgery. The research coordinator will walk them through the informed consent form and answer
any questions about the study. This will occur either at St Paul's Hospital, or over the
phone or via telehealth video conference.
Information will be collected regarding all participants who were approached to consent for
OS. For those who agree to participate in the study, a short questionnaire will be applied to
collect some additional information that would not be available in the chart. Those who
decline OS will be asked about their reasons for not participating to better understand the
patient perspective, inform future research and develop lay communication materials around
OS. The percentage of participants who consented to OS will be calculated, as well as those
who successfully had both fallopian tubes removed during their colorectal surgery.
To calculate how much additional operating room (OR) time is required when OS is performed
concurrently with colorectal surgery, the research coordinator will attend the OR and record
the amount of time taken for both fallopian tubes to be removed or for the attempt to be
abandoned (in rare cases where both tubes are not removed).
To assess the safety of providing OS at the time of colorectal surgery, postoperative
complications will be addressed, including duration of hospital stay and 30-day hospital
readmission rate, blood transfusion and surgical site infection. All participants will
receive standard post-operative care. All data on perioperative complications are available
in the participant's medical chart. The research coordinator will access this information for
the research team. Perioperative complications will be graded according to the Clavien-Dindo
classification of surgical complications, which uses a grading approach. Grade 1 represents
any deviation from the normal postoperative course that does not require the need for
additional treatment beyond the use of antiemetics, antipyretics, analgesics, diuretics,
electrolytes and physiotherapy. Grade 2 represents complications that require pharmacologic
treatment beyond what is included for grade 1 complications and includes blood transfusions.
Grade 3 includes complications that require surgical, endoscopic, or radiological
intervention, Grade 4 includes life threatening complications requiring admission to
intensive care and Grade 5 is death of the patient.
To determine the cost effectiveness of OS at the time of colorectal surgery, the data
generated regarding additional OR time and any additional complications will be used to
conduct Markov Monte Carlo simulation models. Monte Carlo simulations will estimate the
number of people who will be diagnosed with HGSC in the future after OS compared to those not
having this procedure, based on the effectiveness data generated from OS at the time of
hysterectomy and tubal ligation. Direct and indirect health care costs will be derived from
previously existing sources, including patient cost estimators from the Canadian Institute
for Health Information that includes provincial cost estimates for colorectal surgeries by
province. Lifetime risks of HGSC will be modeled from the Canadian Cancer Statistics.
Competing mortality risks that are age and sex dependent will be derived from Canadian Life
Tables. The researchers will use published costs for treatment of HGSC and compare the direct
HGSC-related costs (costs associated with either prevention or treatment of HGSC) across the
groups.
Reporting for adverse events:
All potential side effects related to study interventions will be recorded. Adverse events
will be monitored on an ongoing basis by the research coordinator, and frequencies will be
reported to investigators bimonthly.
Any Clavien-Dindo complication of 3, 4, or 5 (more serious) will be immediately reviewed. The
rate of Clavien-Dindo grade 1 and 2 complications will be reviewed at interim analyses, which
will be conducted when 1/3 of participants have been recruited and again when 2/3rd have been
recruited.
If the study shows that adverse events, serious or not, are occurring at a higher rate for
people undergoing OS compared to baseline expected rates the study may be stopped early. If
unanticipated adverse events are discovered, the study may be stopped early. In either case,
there would be no further recruitment.
In the case of study stoppage, all colorectal surgeons at St Paul hospital will be
immediately notified in writing. The research coordinator will no longer recruit and consent
patients at St Paul's hospital.
