Erfassung Des Low Anterior Resection Syndroms Nach Rektumresektion Bei Patienten Mit Einem Rektumkarzinom - Eine österreichweite Multi-center Studie
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Detection of Low Anterior Resection Syndrome (LARS) after anterior rectal resection.
研究概览
简要总结
The ACO-ASSO (Austrian Society of Surgical Oncology) colorectal group and Austrian Working Group for Coloproctology present the LARS Austria study. It is a prospective, multicenter observational study. The primary objective of this study is to collect information about LARS (LARS score) and QoL (EORTC -CR29) in patients with non-metastatic rectal cancer who received therapy. As a secondary objective, the impact of radiotherapy on the occurrence of LARS will be investigated.
详细描述
All consecutive patients with biopsy verified rectal cancer (≤16cm from anocutaneous line) can be included in the study. For the study, tumors whose aboral margin, when measured with a rigid rectoscope, is 16 cm or less from the anocutaneous line will be included. Thus, only histologically verified tumors of the lower (<6 cm), middle (6<12 cm) and upper (12-16cm) rectal thirds are included.
Patients will be included after the indication for further therapy has been established in the tumor board according to guideline criteria and after signing the participation consent. The collection of study relevant data will be performed according to the following scheme:
Group 1 = patients without neoadjuvant radiochemotherapy (RCHT). Collection of data and questionnaires before surgery and 3, 6, and 12 months after index surgery (if no protective stoma).
OR Collection of data and questionnaires before surgery and 3, 6, or 12 months after stoma re-operation (if protective stoma).
Group 2 = patients with neoadjuvant RCHT/ definitive RCHT=watch and wait. Collection of data and questionnaires before RCHT and before surgery or after RCHT and 3, 6, or 12 months after index surgery (if no protective stoma).
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
- •Age: 18 to 99 years
- •Patients with biopsy-verified rectal cancer.
- •Patients scheduled for elective sphincter-preserving rectal surgery
- •Patients scheduled for neoadjuvant RCTx (Chemo-radiation) (concept: short course radiation, conv.
- •fractionated RCTx, total neoadjuvant therapy(TNT))
- •Signed consent (ICF)
排除标准
- •Patients younger than 18 years
- •Patients without signed informed consent
- •Metastatic carcinoma
- •terminal colostomy ( APR (abdominoperineal resection),...)
结局指标
主要结局
Detection of Low Anterior Resection Syndrome (LARS) after anterior rectal resection.
时间窗: 12 months after the rectum resection or after the closure of a protective ileostomy or after an Chemoradiation in case of watch and wait
Occurrence of Low Anterior Resection Syndrome (LARS) will be measured with an LARS Score. The score ranges from 0 to 42 is divides into no LARS (0 to 20 points), minor LARS (21 to 29 points), and major LARS (30 to 42 points)
次要结局
- Assessing the difference in LARS Score between the time of the diagnoses (baseline)and after the chemoradiation to identify the impact of the neoadjuvant Chemo-Radiation on LARS.(At the time of the diagnosis (baseline) and 6 to 8 weeks after an Chemo-Radiation, directly before the surgery respectively.)
研究者
Jaroslav Presl
Principal Investigator
Paracelsus Medical University