Assessment of Quality of Life After Low Anterior Resection or Visceral Peritoneal Stripping During cytOreDuctive surgerY for Advanced Ovarian Cancer Requiring Tumor Resection on the Rectosigmoid Colon: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Frequency of major LARS after surgery
研究概览
简要总结
This study aims to evaluate the incidence of low anterior resection syndrome and quality of life after cytoreductive surgery for advanced ovarian cancer patients.
详细描述
In advanced ovarian cancer, 24-64% of patients require removal of tumors located in the rectum and sigmoid colon. In order to remove the tumor located in the rectum and sigmoid colon, low anterior resection (LAR) is performed to excise the rectum and sigmoid colon. All patients who underwent low anterior resection are at risk of developing low anterior resection syndrome, which presents symptoms such as frequent bowel movements, frequent defecation, and impaired stool control. Therefore, this study aims to evaluate the incidence of low anterior resection syndrome and quality of life after cytoreductive surgery for advanced ovarian cancer patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Those with newly diagnosed ovarian cancer, fallopian tube cancer and primary peritoneal carcinomatosis who plan to undergo cytoreductive surgery and secondary cytoreductive surgery after neoadjuvant chemotherapy.
- •Patients with PCDS or rectal and sigmoid coloni tumor invasion suspected on the preoperative image and need resection of the tumor and clinical FIGO stage IIIB or higher
- •ECOG performance status : 0-2
- •Age over 18
排除标准
- •Patient who underwent low anterior resection in the past
- •Past history of gastrointestinal malignant tumor except to ovarian cancer
- •Patient who have colostomy
- •Patient who underwent radiation therapy to abdominal or pelvic cavity
- •ECOG performance status over 3
- •Patient taking opioid analgesics
- •Patient who have intellectual disability or dementia
结局指标
主要结局
Frequency of major LARS after surgery
时间窗: 12 months after LAR implementation
Frequency of major LARS (corresponding to 30-42 points as a result of LARS questionnaire) 12 months after LAR implementation
次要结局
- EORTC QLQ-Ov28(2weeks before surgery, 6,12,24 months after surgery)
- Bristol stool form scale(2weeks before surgery, 2weeks after surgery(before adjuvant chemotherapy), 3,6,12,24 months after surgery)
- Incidence of major, minor LARS after visceral peritoneal stripping(2weeks after surgery)
- LARS severity(2weeks before surgery, 2weeks after surgery(before adjuvant chemotherapy), 3,6,12,24 months after surgery)
- The fecal incontinency quality of life scale(FIQL)(2weeks before surgery, 2weeks after surgery(before adjuvant chemotherapy), 3,6,12,24 months after surgery)
- EOTC QLQ-C30(2weeks before surgery, 6,12,24 months after surgery)