Organ Specific Late Adverse Effects, in Colorectal Cancer Patients Following Surgery With Either HIPEC or Pelvic Exenteration
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 225
- 试验地点
- 3
- 主要终点
- Development of female urological dysfunction after PE or CRS+HIPEC for colorectal cancer
研究概览
简要总结
The purpose of this study is to describe type and extent of organ specific late adverse effects in patients undergoing surgery for colorectal cancer with peritoneal metastases and after surgery for colorectal cancer with involvement of the urinary bladder.
详细描述
After being informed about the study all patients giving written informed consent will be distributed a questionnaire asking questions on bowel function, urinary function, pain, sexual function and lymphedema. All these aspects will be investigated using validated questionnaires.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have undergone intended curative CRS+HIPEC for peritoneal metastases originated from colorectal cancer (HIPEC cohort) according to national Danish guidelines
- •Patients who have undergone intended curative total or anterior pelvic exenteration (PE cohort) for advanced or recurrent colorectal cancer according to national Danish guidelines
排除标准
- •Patients under 18 years
- •Patients not speaking Danish or Swedish, respectively, in Denmark and Sweden
- •Patients unable to give informed consent
- •Patients undergoing CRS+HIPEC or PE for cancers others than CRC
- •Terminally ill patients
结局指标
主要结局
Development of female urological dysfunction after PE or CRS+HIPEC for colorectal cancer
时间窗: PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery.
Descriptive analysis will be done using following questionaires: ICIQ-FLUTS (ICIQ female lower urinary tract symptoms)
Development of bowel related adverse effects after PE or CRS+HIPEC for colorectal cancer
时间窗: PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery.
Descriptive analysis will be done using following questionnaires: LARS score (low anterior resection syndrome)
Development of male urological dysfunction after PE or CRS+HIPEC for colorectal cancer
时间窗: PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery.
Descriptive analysis will be done using following questionaires: ICIQ-MLUTS (ICIQ male lower urinary tract symptoms)
Development of pain after PE or CRS+HIPEC for colorectal cancer
时间窗: PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery.
Descriptive analysis will be done using following questionaire: rectal cancer pain score
Development of male sexual dysfunction after PE or CRS+HIPEC for colorectal cancer
时间窗: PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery.
Descriptive analysis will be done using following questionaires: IIEF-5 (international index of erectile dysfunction)
Development of female sexual dysfunction after PE or CRS+HIPEC for colorectal cancer
时间窗: PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery.
Descriptive analysis will be done using following questionaires: Rectal cancer female sexuality score
Development of lymphedema after PE for colorectal cancer
时间窗: PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery
Descriptive analysis will be done using following questionaire: Questions regarding lymphedema from EORTC vulva cancer questionnaire
Development of stoma-related issues after PE or CRS+HIPEC for colorectal cancer
时间窗: PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery.
Descriptive analysis will be done using following questionaire: Colostomy impact score
次要结局
- Risk factors associated with developing organ specific late adverse effects(PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects3, 6, 12, 18, 24, 36, 48 and 60 months after surgery.)