RecruitingNot ApplicableNCT07213193

No-Stoma Policy in Advanced Ovarian Cancer Surgery

No-Stoma Policy in Advanced Ovarian Cancer Surgery, Feasibility and Outcomes


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

395 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether ovarian cancer surgery that involves removing part of the bowel can safely be completed without creating a temporary colostomy bag (stoma). Researchers want to see if joining the bowel back together directly is safe for patients. **You may be eligible if...** - You are 18 years old or older - You have suspected or confirmed ovarian cancer and are scheduled for surgery that will require removing and reconnecting a portion of your rectum or sigmoid colon **You may NOT be eligible if...** - Your cancer is not ovarian cancer - Your surgery is planned only for comfort/palliative purposes - During surgery, it turns out you do not need a bowel resection - You end up needing a permanent colostomy rather than a reconnection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREcolon-rectal resection

The patients who underwent colon rectal resection, would be evaluated for stomia or not.


Locations(1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Ginecologia Oncologica

Roma, Italy

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NCT07213193


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