No-Stoma Policy in Advanced Ovarian Cancer Surgery, Feasibility and Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 395
- 试验地点
- 1
- 主要终点
- Rate of Anastomotic Dehiscence in Low-Risk Patients Undergoing Primary or Secondary Cytoreductive Surgery for Ovarian, Fallopian Tube, or Peritoneal Tumors
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Women with ovarian cancer
Patients women who underwent colon rectal resection
干预措施: colon-rectal resection (Procedure)
结局指标
主要结局
Rate of Anastomotic Dehiscence in Low-Risk Patients Undergoing Primary or Secondary Cytoreductive Surgery for Ovarian, Fallopian Tube, or Peritoneal Tumors
时间窗: Intraoperative and postoperative follow-up period (90 days postoperative)
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.
次要结局
- 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.)