Avoiding a stoma after rectosigmoid surgery for advanced ovarian cancer
Official title: No-Stoma Policy in Advanced Ovarian Cancer Surgery, Feasibility and Outcomes
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT07213193 · Data updated 2026-11-12
This trial tests whether avoiding a protective stoma after rectosigmoid resection is safe for people undergoing cytoreductive surgery for advanced ovarian cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 395 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Status | Recruiting |
| Started | May 1, 2025 |
| Main results expected | June 1, 2028 |
| Study ends | December 20, 2028 |
| Registry record updated | October 8, 2025 |
| Trial ID | NCT07213193 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.