NCT07213193 No-Stoma Policy in Advanced Ovarian Cancer Surgery
| NCT ID | NCT07213193 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Ovary Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 395 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2028-06-01 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 395 participants in total. It began in 2025-05-01 with a primary completion date of 2028-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Resection of the sigmoid-rectum is a procedure frequently required in cytoreductive surgery for advanced ovarian cancer, and it is also among the procedures with the highest risk of complications. One of the major, albeit uncommon, complications of intestinal anastomosis is anastomotic leakage. According to the literature, the rate of anastomotic leakage following cytoreductive surgery for ovarian cancer ranges from 1.7% to 17%. The risk factors associated with this complication are varied and often inconsistent across studies. They range from preoperative clinical conditions-such as age, low albumin levels, and Body Mass Index \< 18-to intraoperative factors such as low to mid rectal resection, high ligation of the inferior mesenteric artery, and multiple bowel resections. Apart from the rehabilitative programs introduced by the Enhanced Recovery After Surgery protocol-which aim to improve the nutritional status of patients undergoing cytoreductive surgery for ovarian cancer-we currently lack validated tools to reduce the risk of leakage. The most commonly used strategy remains the creation of a protective stoma. However, several studies have shown that this procedure is not actually a protective factor against anastomotic leakage; rather, its utility lies in mitigating the severity of the complication. Nonetheless, stomas have a significant clinical and psychological impact, with complication rates ranging from 33.9% to 45% and reversal rates between 66.5% and 89%. This study aims to evaluate the feasibility of a no-stoma strategy in a selected "low-risk" population for anastomotic leakage among patients undergoing cytoreductive surgery for primary or recurrent ovarian cancer. Focusing on the goal of achieving a zero stoma rate, the study will provide valuable insights into the utility and outcomes of stoma creation. The results will support more informed and patient-centered clinical decisions in the management of ovarian cancer.
Eligibility 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
Contact & Investigator
Virginia Vargiu
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT07213193 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Ovary Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07213193 currently recruiting?
Yes, NCT07213193 is actively recruiting participants. Contact the research team at virginia.vargiu@policlinicogemelli.it for enrollment information.
Where is the NCT07213193 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT07213193 clinical trial?
NCT07213193 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Virginia Vargiu at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 395 participants.
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