No-Stoma Policy in Advanced Ovarian Cancer Surgery

NCT ID: NCT07213193

Last Updated: 2025-10-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 395 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2028-12-20

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.

Conditions

Ovary Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Women with ovarian cancer

Patients women who underwent colon rectal resection

Group Type: EXPERIMENTAL

colon-rectal resection

Intervention Type: PROCEDURE

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

Interventions

colon-rectal resection

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Virginia Vargiu

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Locations

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Ginecologia Oncologica

Roma, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Virginia Vargiu

Role: CONTACT

virginia.vargiu@policlinicogemelli.it

+393387106039

Facility Contacts

VIRGINIA VARGIU

Role: primary

virginia.vargiu@policlinicogemelli.it

+393387106039

Other Identifiers

7620

Identifier Type: -

Identifier Source: org_study_id