Avoiding a stoma after rectosigmoid surgery for advanced ovarian cancer
No-Stoma Policy in Advanced Ovarian Cancer Surgery, Feasibility and Outcomes
NA · Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT07213193
This trial tests whether avoiding a protective stoma after rectosigmoid resection is safe for people undergoing cytoreductive surgery for advanced ovarian cancer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 395 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other) |
| Locations | 1 site (Roma) |
| Trial ID | NCT07213193 on ClinicalTrials.gov |
What this trial studies
Rectosigmoid resection with colorectal anastomosis is often required during cytoreductive surgery for advanced ovarian cancer and carries a reported anastomotic leakage risk of 1.7% to 17%. This interventional, single-center protocol at Fondazione Policlinico Universitario Agostino Gemelli IRCCS enrolls adults undergoing elective primary or secondary cytoreduction who require rectosigmoid resection and colorectal anastomosis and implements a no-stoma (no diverting ostomy) surgical policy. Participants provide informed consent and are followed for postoperative outcomes including anastomotic leakage, need for reoperation, and other surgical morbidity. Patients with non-ovarian histology, planned palliative surgery, or those who intraoperatively require an end ostomy are excluded.
Who should consider this trial
Good fit: Adults (18 years or older) with suspected or confirmed ovarian cancer undergoing elective primary or secondary cytoreductive surgery who need rectosigmoid resection and will receive a colorectal anastomosis.
Not a fit: Patients with non-ovarian tumors, those planned for palliative procedures, or those who do not receive a colorectal anastomosis and undergo an end ostomy are unlikely to benefit from this no-stoma approach.
Why it matters
Potential benefit: If successful, patients could avoid temporary or permanent stomas and their related morbidity, improving recovery and quality of life.
How similar studies have performed: Some retrospective series and institutional reports have shown acceptable leak rates without routine diverting stomas, but high-quality prospective evidence is limited and findings are inconsistent.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with suspected or anatomopathological diagnosis of malignant ovarian tumor undergoing elective primary or secondary cytoreduction and needing rectosigmoid resection and anastomosis * Informed consent signed prior to performing any procedure related to the clinical trial * Age 18 years old. Exclusion Criteria: * Patients with histologies other than ovarian tumor. * Only palliative surgery planned * Patients who do not require sigmoid-rectum resection after intraoperative evaluation * Patients who do not receive colorectal anastomosis and undergo end ostomy
Where this trial is running
Roma
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Ginecologia Oncologica — Roma, Italy (RECRUITING)
Study contacts
- Principal investigator: Virginia Vargiu — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Virginia Vargiu
- Email: virginia.vargiu@policlinicogemelli.it
- Phone: +393387106039
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.
Conditions: Ovary Cancer