Clinical trial Recruiting at 1 site Interventional Ages 18 and up Women only

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 typeInterventional
Ages18 Years and up
SexWomen only
Enrollment395 (estimated)
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
Academic / other
Locations1 site (Roma)
StatusRecruiting
StartedMay 1, 2025
Main results expectedJune 1, 2028
Study endsDecember 20, 2028
Registry record updatedOctober 8, 2025
Trial IDNCT07213193 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.