Opportunistic Salpingectomy During Colorectal Surgery

Recruiting at 1 trial location

Overseen By Gillian Hanley, PhD

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: BRCA 1 or 2 mutation

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

240 Participants Needed

Trial Summary

What is the purpose of 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 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is opportunistic salpingectomy during colorectal surgery safe?

The research on laparoscopic colorectal surgery, which is a minimally invasive approach, suggests it is generally safe and offers benefits like reduced blood loss and shorter hospital stays. However, specific safety data for opportunistic salpingectomy during colorectal surgery is not provided in the available research. ^{1 2 3 4 5}

How is the treatment 'Opportunistic Salpingectomy During Colorectal Surgery' different from other treatments for colorectal surgery?

This treatment is unique because it involves the removal of fallopian tubes during colorectal surgery to potentially prevent ovarian cancer, which is not a standard part of colorectal surgery. This approach combines cancer prevention with another surgical procedure, offering a dual benefit. ^{6 7 8 9 10}

Research Team

Gillian Hanley, PhD

Principal Investigator

University of British Columbia

Heather Stuart, MD

Principal Investigator

University of British Columbia

Carl Brown, MD

Principal Investigator

St. Paul's Hospital

Eligibility Criteria

This trial is for people with intact fallopian tubes who are having certain types of colorectal surgery (like total colectomy or appendectomy) and have completed childbearing. It's not for those with BRCA 1 or 2 mutations.

Inclusion Criteria

My fallopian tubes are intact.

Individuals who finished with childbearing

I am having surgery for my colon or small bowel.

Exclusion Criteria

I have a BRCA 1 or 2 mutation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or virtual)

Preoperative Consent

Participants are consented to undergo OS or participate as a control at a preoperative visit

1 day

1 visit (in-person or virtual)

Surgical Intervention

Participants undergo colorectal surgery with or without opportunistic salpingectomy

1 day

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for surgical complications and adverse events

30 days

Ongoing monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Treatment Details

Interventions

• Bilateral Salpingectomy
• Colorectal Surgery

Trial Overview The study tests the addition of a procedure called opportunistic salpingectomy, which removes the fallopian tubes, to routine colorectal surgeries to see if it can prevent ovarian cancer without adding risks.

Participant Groups

Group I: Opportunistic salpingectomy Experimental Treatment 2 Interventions

The participating surgeons will attempt to perform bilateral salpingectomy in addition to the colorectal surgery.

Group II: Colorectal surgery only Active Control 1 Intervention

Participants will receive the standard of care, that is colorectal surgery.

Colorectal Surgery is already approved in Canada, United States, European Union for the following indications:

Approved in Canada as Opportunistic Salpingectomy for:

• Prevention of Ovarian Cancer
• Specifically High Grade Serous Carcinoma (HGSC)

Approved in United States as Opportunistic Salpingectomy for:

• Prevention of Ovarian Cancer
• Specifically High Grade Serous Carcinoma (HGSC)

Approved in European Union as Opportunistic Salpingectomy for:

• Prevention of Ovarian Cancer
• Specifically High Grade Serous Carcinoma (HGSC)

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Canadian Cancer Society (CCS)

Collaborator

Trials

84

Recruited

42,100+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Findings from Research

A study involving 143 patients showed that laparoscopic colorectal surgery is technically feasible and safe, with a conversion rate of 14.7% and an overall 30-day morbidity rate of 21.7%.

Despite longer operative times averaging 203 minutes, laparoscopic surgery resulted in a shorter mean postoperative stay of 5.6 days, supporting its benefits over traditional open surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From small acorns--developing a laparoscopic colorectal surgical service. Smith, JK., Acheson, AG., Simpson, JA., et al.[2018]

In a study of 54,237 colorectal surgery patients, 26% experienced postoperative adverse events, which significantly increased the likelihood of prolonged hospital stays and mortality.

Patients who suffered serious complications like cardiac arrest, septic shock, stroke, myocardial infarction, or renal failure had the highest risk of dying within 30 days after surgery, highlighting the importance of monitoring these conditions postoperatively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Which adverse events are associated with mortality and prolonged length of stay following colorectal surgery? Ricciardi, R., Roberts, PL., Read, TE., et al.[2021]

In a study of the first 100 elective laparoscopic colorectal surgeries over 2 years, the rate of major surgical complications significantly decreased from 20% in the first 50 cases to 0% in the subsequent 50 cases, indicating improved safety as surgeons gained experience.

The average operative time also improved, decreasing from 180 minutes to 160 minutes, and the average hospital stay reduced from 8.6 days to 7.2 days, demonstrating increased efficiency with experience in laparoscopic techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Learning curve in laparoscopic colorectal surgery: our first 100 patients. Avital, S., Hermon, H., Greenberg, R., et al.[2018]

Laparoscopic colectomy is generally safe and can be performed successfully in most cases, indicating its feasibility as a surgical option.

The patient-related benefits of laparoscopic colorectal surgery are comparable to those seen in other laparoscopic procedures, suggesting it is a quality surgical approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic colon and rectal surgery. Talac, R., Nelson, H.[2019]

In a study of 5744 patients with N2 colorectal cancer, minimally invasive surgery yielded equivalent nodal harvests compared to open surgery, indicating its effectiveness in this advanced stage of cancer.

Minimally invasive surgery was associated with fewer perioperative complications, such as anastomotic leaks and mortality, compared to open surgery, suggesting it may be a safer option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimally Invasive Surgical Approaches Are Safe and Appropriate in N2 Colorectal Cancer. Guidolin, K., Spence, RT., Chadi, SA., et al.[2023]

The rate of opportunistic salpingectomy (OS) during hysterectomies increased significantly from 15.4% in 2011 to 35.5% in 2016, indicating a growing recognition of its role in ovarian cancer prevention among 318,528 patients studied.

For tubal sterilizations, OS rates also rose from 6.5% to 22.0% over the same period, with notable regional differences, suggesting that some areas, like British Columbia, have adopted this practice more widely than others.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opportunistic salpingectomy between 2011 and 2016: a descriptive analysis. Hanley, GE., Niu, J., Han, J., et al.[2022]

A survey of 117 gynecologic surgeons revealed that 83.8% perform opportunistic salpingectomy (OS) during prolapse repair, which is comparable to the 82.1% rate during hysterectomy for non-prolapse reasons.

Factors such as performing OS during non-prolapse hysterectomy, using laparoscopic or robotic techniques, and completing a fellowship in Female Pelvic Medicine and Reconstructive Surgery were linked to a higher likelihood of performing OS during prolapse repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survey of pelvic reconstructive surgeons on performance of opportunistic salpingectomy at the time of pelvic organ prolapse repair. Hassani, DB., Mangel, JM., Mahajan, ST., et al.[2022]

This study aims to evaluate whether opportunistic salpingectomy, performed during sterilization, affects the age at which women experience menopause compared to those who undergo tubal ligation or no surgery, involving 1200 participants over a maximum follow-up of 15 years.

The hypothesis is that opportunistic salpingectomy does not lead to an earlier onset of menopause, with participants providing annual updates on their menopausal status to assess any significant differences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

STop OVarian CAncer (STOPOVCA) young: Protocol for a multicenter follow-up study to determine the long-term effects of opportunistic salpingectomy on age at menopause. Gelderblom, ME., IntHout, J., Hermens, RPMG., et al.[2022]

Between 2017 and 2020, the rate of opportunistic salpingectomy (OS) during hysterectomies increased from 31.7% to 39.9%, and during tubal sterilizations from 26.3% to 42.5%, indicating a growing recognition of its role in ovarian cancer prevention.

Despite the increase in OS rates, the study identified approximately 76,932 missed opportunities for ovarian cancer prevention, suggesting that more patients could benefit from this procedure during surgeries where it is applicable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opportunistic salpingectomy between 2017 and 2020: A descriptive analysis. Kaur, P., Rufin, K., Finlayson, SJ., et al.[2023]

Opportunistic salpingectomy (OS) does not significantly affect ovarian reserve in the short term, as shown by a meta-analysis of 15 studies that measured various hormonal markers.

There is currently no evidence to suggest that OS impacts the age at which menopause begins, highlighting the need for further research to explore this potential effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of opportunistic salpingectomy for primary prevention of ovarian cancer on ovarian reserve: a systematic review and meta-analysis. Gelderblom, ME., IntHout, J., Dagovic, L., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

From small acorns--developing a laparoscopic colorectal surgical service. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Which adverse events are associated with mortality and prolonged length of stay following colorectal surgery? [2021]

3. Israel pubmed.ncbi.nlm.nih.gov

Learning curve in laparoscopic colorectal surgery: our first 100 patients. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Laparoscopic colon and rectal surgery. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Minimally Invasive Surgical Approaches Are Safe and Appropriate in N2 Colorectal Cancer. [2023]

6. Canada pubmed.ncbi.nlm.nih.gov

Opportunistic salpingectomy between 2011 and 2016: a descriptive analysis. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Survey of pelvic reconstructive surgeons on performance of opportunistic salpingectomy at the time of pelvic organ prolapse repair. [2022]

8. Ireland pubmed.ncbi.nlm.nih.gov

STop OVarian CAncer (STOPOVCA) young: Protocol for a multicenter follow-up study to determine the long-term effects of opportunistic salpingectomy on age at menopause. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Opportunistic salpingectomy between 2017 and 2020: A descriptive analysis. [2023]

10. Ireland pubmed.ncbi.nlm.nih.gov

The effect of opportunistic salpingectomy for primary prevention of ovarian cancer on ovarian reserve: a systematic review and meta-analysis. [2023]