No-Stoma Policy in Advanced Ovarian Cancer Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: colon-rectal resection.
- Who it may be relevant to
- Registry conditions: Ovary Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
No-Stoma Policy in Advanced Ovarian Cancer Surgery, Feasibility and Outcomes
Overview
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.
Interventions
- Procedure colon-rectal resection
The patients who underwent colon rectal resection, would be evaluated for stomia or not.
Primary outcome measures
- Rate of Anastomotic Dehiscence in Low-Risk Patients Undergoing Primary or Secondary Cytoreductive Surgery for Ovarian, Fallopian Tube, or Peritoneal Tumors [Time frame: Intraoperative and postoperative follow-up period (90 days postoperative)]
Secondary outcome measures (4)
- Risk Factors for Anastomotic Leak [Time frame: preoperative, intraoperative]
- Rate of Occult Anastomotic Leak in Patients With Diverting Ostomy [Time frame: Postoperative days up to 20.]
- Management Strategies for Anastomotic Leak [Time frame: Postoperative period (up to 90 days).]
- Impact of Bowel Surgery on Quality of Life [Time frame: Baseline (pre-surgery), 3 months, and 6 months post-surgery.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Italy · 1 center
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Ginecologia Oncologica — Roma
Identifiers
NCT: NCT07213193 · 7620