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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and effectiveness of removing the fallopian tubes during colorectal surgery to help prevent ovarian cancer. The focus is on preventing high-grade serous carcinoma, a common and serious type of ovarian cancer. Individuals with intact fallopian tubes undergoing specific colorectal surgeries might be suitable candidates. The trial compares those who undergo bilateral salpingectomy (removal of the fallopian tubes) during surgery with those receiving only standard colorectal surgery. Researchers believe this additional step could reduce ovarian cancer cases cost-effectively without increasing risk. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could significantly advance cancer prevention.

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.

What prior data suggests that opportunistic salpingectomy during colorectal surgery is safe?

Research has shown that removing the fallopian tubes, known as opportunistic salpingectomy (OS), is generally safe during pelvic surgeries. Studies have found that OS does not increase the risk of complications. For instance, one study found it might even reduce the need for additional surgeries later. Another review confirmed that OS is well-tolerated when performed with other pelvic surgeries.

Although specific data on OS during colorectal surgery is not yet available, these findings suggest it could be safe. The research team believes that adding OS to colorectal surgery won't significantly increase the time or risks. They expect OS to add about 10-20 minutes to the surgery without increasing complications.

Overall, past studies on OS in similar surgeries provide encouraging evidence for its safety and potential benefits in reducing the risk of ovarian cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential benefits of adding opportunistic salpingectomy to standard colorectal surgery. Unlike typical colorectal surgeries that focus solely on removing or repairing sections of the colon, this approach includes the removal of the fallopian tubes (salpingectomy) during the same procedure. This technique could potentially reduce the risk of ovarian cancer by removing tissues that might later harbor precancerous cells. If proven effective, it could offer a dual benefit for patients undergoing colorectal surgery, addressing both their immediate colorectal needs and their long-term cancer risk.

What evidence suggests that opportunistic salpingectomy during colorectal surgery is effective for preventing ovarian cancer?

Research has shown that removing the fallopian tubes, a procedure known as opportunistic salpingectomy (OS), can lower the risk of high-grade serous carcinoma, a type of ovarian cancer. Studies indicate that performing OS during surgeries unrelated to the reproductive system can reduce the chance of developing ovarian cancer by over 20%. In this trial, some participants will undergo colorectal surgery with OS, while others will receive only colorectal surgery. Patients who have undergone OS have experienced a high success rate of about 93.3% in safely removing the fallopian tubes. This procedure is considered safe and can be performed alongside other surgeries, such as those on the colon, with minimal additional time in the operating room. Additionally, OS might save money by potentially reducing the number of ovarian cancer cases and the associated treatment costs. ^{2 3 6 7 8}

Who Is on the Research Team?

Gillian Hanley, PhD

Principal Investigator

University of British Columbia

Carl Brown, MD

Principal Investigator

St. Paul's Hospital

Heather Stuart, MD

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12033089/

opportunistic salpingectomy—molecular pathology, clinical ... A retrospective study conducted at a single center demonstrated that performing opportunistic salpingectomy can reduce the risk of re-surgical ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11781718/

Ovarian cancer prevention through opportunistic ... Table 1. Clinical and cost effectiveness of opportunistic salpingectomy in base case simulation with 1,200,000 women over 65 annual cycles ( ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05300711

Study Details | NCT05300711 | Preventing Ovarian Cancer ... This study aims to evaluate the feasibility, safety and cost-effectiveness of opportunistic salpingectomy (OS-the removal of the fallopian tubes) at the ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2352578925000104

The potential for opportunistic salpingectomy to reduce ... Ovarian cancer incidence could be reduced by > 20 % by adopting opportunistic salpingectomy during non-gynecologic procedures.

5. mdpi.com mdpi.com/2673-4095/5/2/23

Opportunistic Salpingectomy at the Time of General ... While limited evidence currently exists to cite an exact feasibility rate, the previously demonstrated 93.3% success rate is certainly promising ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05300711

Study Details | NCT05300711 | Preventing Ovarian Cancer ... This study aims to evaluate the feasibility, safety and cost-effectiveness of opportunistic salpingectomy (OS-the removal of the fallopian tubes) at the ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10742942/

Beyond Sterilization: A Comprehensive Review on the ... In conclusion, the available data suggest that opportunistic bilateral salpingectomy during pelvic surgeries or as tubal sterilization is a safe ...

8. acog.org acog.org/clinical/clinical-guidance/committee-opinion/articles/2019/04/opportunistic-salpingectomy-as-a-strategy-for-epithelial-ovarian-cancer-prevention

Opportunistic Salpingectomy as a Strategy for Epithelial ... In the Swedish study, women who underwent bilateral salpingectomy had a 65% reduction in the risk of ovarian cancer and women who underwent sterilization had a ...