Assessment of Symptoms and Their Consequences on Patients Quality of Life After Coloanal Continuity Reconstruction Following a Proctectomy for Rectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Quality of life 1 year after the second intervention, using LARS score
研究概览
简要总结
This study is a prospective, monocentric study whose aim is to assess the quality of life for patients who underwent a coloanal continuity reconstruction and to understand the functional issues they encounter. This will potentially provide predictive factors identification of bad functional outcomes allowing to guide future decisions. Also, it will allow patients to have a reinforced follow-up during the year after the reconstruction.
详细描述
First of all, an information document will be given to the patients and their consent will be collected. Then, they will be registered through the online eCRF (or by FAX) and a study number will be given to each patient.
The study will proceed with 2 stomatherapy consultations at one and six months after coloanal continuity reconstruction. Patient care and following up will proceed as usual. The stomatherapy consultation will be done by a qualified nurse.
Before the 1st intervention (proctectomy):
- Collect of clinical data and disease history
- Quality of life questionnaires (EORTC-QLQ-C30 and CR29)
- Evaluation of LARS score
After the 1st intervention (proctectomy, at month 1):
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 70 years old
- •Patients who are going to undergo a proctectomy for a rectal cancer (situated at a distance equal or lower to 15 cm from the anoderm) following by a coloanal continuity reconstruction (using direct, latero-terminal or colonic J-pouch anastomosis)
- •Already underwent or not a neoadjuvant radio-chemotherapy
- •Affiliation to the National Social Security System
- •With informed and signed consent
排除标准
- •Unwilling patients
- •Patient deprived of their liberty or under guardianship or tutorship.
- •Abdominal perineal amputation
- •No stoma placement planned
- •Tumor more than 15 cm from the anal margin
研究组 & 干预措施
Study process
Pre- and post-operative consultations. Stomatherapy consultation. Questionnaires
干预措施: Pre- and post-operative consultation (Procedure)
Study process
Pre- and post-operative consultations. Stomatherapy consultation. Questionnaires
干预措施: Stomatherapy consultation (Procedure)
Study process
Pre- and post-operative consultations. Stomatherapy consultation. Questionnaires
干预措施: Questionnaires (Procedure)
结局指标
主要结局
Quality of life 1 year after the second intervention, using LARS score
时间窗: from baseline to 1 year after the second intervention
Obtain an objective assessment of symptoms intensity (using the LARS score)for patients who received a proctectomy for rectal cancer ("1st intervention") following by a coloanal continuity reconstruction ("2nd intervention")
次要结局
- Quality of life of patients with a second stoma placement, using EORTC-QLQ-CR29 questionnaires(From the 2nd intervention to one year after the 2nd intervention)
- Quality of life using EORTC-QLQ-C30(from baseline to one year after the 2nd intervention)
- Surgical complications description(from first intervention to one year after the 2nd intervention)
- Quality of life before the first intervention and after the second intervention(from baseline to one year after the 2nd intervention)
- Rate of patients with anastomotic fistula(from the first intervention to 6 months after the first intervention)
- Quality of life of patients with a second stoma placement, using EORTC-QLQ-C30 questionnaires(From the 2nd intervention to one year after the 2nd intervention)
- Quality of life using EORTC-QLQ-CR29 questionnaires(from baseline to one year after the 2nd intervention)
- Impact of stomy on quality of life(from the first intervention to 6 months after the first intervention)
- Quality of life of patients with a second stoma placement, using LARS score(From the 2nd intervention to one year after the 2nd intervention)