No-Stoma Policy in Advanced Ovarian Cancer Surgery

NCT07213193 | Recruiting

• 1 other identifier: 7620
• Study Type: interventional
• Target: 395
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Rate of Anastomotic Dehiscence in Low-Risk Patients Undergoing Primary or Secondary Cytoreductive Surgery for Ovarian, Fallopian Tube, or Peritoneal Tumors

  The feasibility of a no-stoma policy will be assessed by calculating the rate of anastomotic dehiscence in low-risk patients (who therefore did not receive a diverting stoma) and comparing these results with published data from the literature.

  Intraoperative and postoperative follow-up period (90 days postoperative)

Secondary Outcomes (4)

• Risk Factors for Anastomotic Leak

  preoperative, intraoperative

• Rate of Occult Anastomotic Leak in Patients With Diverting Ostomy

  Postoperative days up to 20.

• Management Strategies for Anastomotic Leak

  Postoperative period (up to 90 days).

• Impact of Bowel Surgery on Quality of Life

  Baseline (pre-surgery), 3 months, and 6 months post-surgery.

Study Arms (1)

Women with ovarian cancer

EXPERIMENTAL

Patients women who underwent colon rectal resection

Procedure: colon-rectal resection

Interventions

colon-rectal resection PROCEDURE

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

Women with ovarian cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Ginecologia Oncologica

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Virginia Vargiu

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Virginia Vargiu

CONTACT

+393387106039; virginia.vargiu@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: October 8, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 20, 2028
• Last Updated: October 8, 2025

Record last verified: 2025-05

Locations

IT (1)