Comparing two surgical methods for ovarian cancer treatment
Comparison of Rectosigmoid Resection and Seromuscular Tumor Shaving Methods in Ovarian Cancer Surgery (BROSEOC)
This study tests which surgical method, either removing part of the rectum or just shaving the tumor, works better for people with advanced ovarian cancer that has spread to that area.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Cukurova University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Adana and 1 other locations) |
| Trial ID | NCT04665635 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of rectosigmoid resection versus seromuscular tumor shaving in patients with epithelial ovarian cancer that has metastasized to the rectosigmoid area. The study aims to determine which surgical approach leads to better outcomes in terms of complete tumor removal and overall patient survival. Participants will undergo one of the two surgical interventions, and their recovery and recurrence rates will be monitored. The trial is crucial as it addresses a common complication in advanced ovarian cancer treatment.
Who should consider this trial
Good fit: Ideal candidates include patients with epithelial ovarian cancer and confirmed serosal or seromuscular rectosigmoid infiltration who meet specific health criteria.
Not a fit: Patients with nonepithelial ovarian cancers or those requiring extensive bowel resections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes and survival rates for patients with advanced ovarian cancer.
How similar studies have performed: While there have been studies on surgical interventions for ovarian cancer, this specific comparison of techniques is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Epithelial ovarian cancer * Negative colonoscopy ( no mucosal involvement) * Intraoperative confirmed serosal or seromuscular rectosigmoid infiltration * ECOG \<3 * ASA \<3 Exclusion Criteria: * Nonepithelial ovarian cancers * Rectosigmoid mucosal infiltration * Total or subtotal colectomy necessitating large bowel infiltrations * ECOG \>2 * ASA \>2
Where this trial is running
Adana and 1 other locations
- Cukurova University — Adana, Turkey (Türkiye) (Not_yet_recruiting)
- Cukurova University — Adana, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Ghanim Khatib, MD
- Email: ghanim.khatib@gmail.com
- Phone: +903223386060
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.