Opportunistic salpingectomy during hysterectomy for benign reasons
Hysterectomy and Opportunistic Salpingectomy
This study is testing if removing the fallopian tubes during a hysterectomy for non-cancer reasons is safe for women under 55 and if it helps lower the risk of ovarian cancer without causing other health issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 4400 (estimated) |
| Ages | 20 Years to 54 Years |
| Sex | Female |
| Sponsor | Göteborg University Academic / other |
| Locations | 1 site (Göteborg) |
| Trial ID | NCT03045965 on ClinicalTrials.gov |
What this trial studies
The HOPPSA trial is a register-based randomized controlled trial aimed at evaluating the safety and efficacy of opportunistic salpingectomy performed concurrently with hysterectomy for benign conditions. It investigates whether this procedure increases surgical complications or negatively affects ovarian function and cardiovascular health while potentially reducing the risk of subsequent ovarian cancer. The study will recruit approximately 4,400 women under 55 years old, with randomization and follow-up conducted through the Swedish National Quality Register of Gynecological Surgery. Outcomes will be assessed at various intervals, including short-term surgical complications and long-term ovarian cancer incidence.
Who should consider this trial
Good fit: Ideal candidates are women under 55 years old who are scheduled for a hysterectomy due to benign conditions.
Not a fit: Patients with a history of bilateral oophorectomy or salpingectomy, or those with known genetic predispositions to ovarian cancer, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly lower the risk of ovarian cancer in women undergoing hysterectomy for benign reasons without increasing surgical risks.
How similar studies have performed: Previous studies have suggested that opportunistic salpingectomy may reduce ovarian cancer risk, but this specific approach is being rigorously tested in a randomized controlled setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Planned hysterectomy for a benign reason * Age \< 55 years at randomization * Willing to be randomized * Vaginal route may be included if the surgeon is confident with performing vaginal salpingectomy. Exclusion Criteria: * Previous bilateral oophorectomy and/or salpingectomy * Planned oophorectomy and/or salpingectomy (for reasons such as already diagnosed adnexal tumor, known carrier of the breast cancer susceptibility gene (BRCA) 1/2 mutation or Lynch syndrome (hereditary nonpolyposis colorectal cancer)) * Non-understanding of the oral or written study information
Where this trial is running
Göteborg
- Sahlgrenska University Hospital — Göteborg, Sweden (Recruiting)
Study contacts
- Principal investigator: Annika Strandell — Sahlgrenska University Hospital
- Study coordinator: Annika Strandell, PI
- Email: annika.strandell@vgregion.se
- Phone: +46 700904454
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.