Comparison of Quality of Life Outcomes Between Laparoscopic and Open Approach for Rectal Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Gender
研究概览
简要总结
Following colorectal surgery, many patients face a combination of physical and emotional problems for a long period of time. Symptoms such as pain, fatigue, and disturbed bowel and sexual function, as well as problems in social and role functioning, inevitably affect the patients' well-being. Therefore, evaluation of the self-reported quality of life (QoL) is becoming increasingly important in clinical trials. The investigators aimed to compare long term health related life quality (HRQoL) results of laparoscopic approach with open approach in patients with sphincter preserving resections for rectal cancer at a single-center.
详细描述
This study is planned prospectively. All patients scheduled for operation due to rectal cancer in our clinic between January 2017 and December 2018 will be evaluated for suitability for the study. During the preoperative examination, patients will be informed about the study and their written consent will be obtained. Patients will be randomized between open and laparoscopic groups in the ratio 2:1, depending on the type of surgery. Clinical data of patients will be analyzed from the hospital database programme.
The EORTC QLQ-C30 and QLQ-CR29 questionnaires prepared by The European Organization for Research and Treatment of Cancer (EORTC) will be used to evaluate the quality of life after the operation. The EORTC QLQ-C30 questionnaire will be completed by examining the patients' daily observation notes. EORTC QLQ-CR29 will be completed with face to face interviews in the first year after surgery.
In this way, it will be aimed to compare the early and long-term quality of life (HRQoL) results of open and laparoscopic approach in patients undergoing surgery for rectal cancer.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who underwent surgery (laparoscopic or open) for rectal cancer in our department.
排除标准
- •The patients whose all oncological treatments had not been completed at least 6 months ago
- •The patients with ASA IV score
- •The patients with previous abdominal surgery
- •The patients who had developed major surgical complications (such as anastomosis leakage, requiring re-laparotomy, evisceration)
- •The patients who underwent a new abdominal surgery except for stoma closure
- •The patients with local recurrence or distant metastases
- •The patients who still had a stoma
- •The patients who did not want to take part in the study
- •The patients who missed in the follow-up period
结局指标
主要结局
Gender
时间窗: Before surgery
Male/Female
BMI
时间窗: Before surgery
kg/m²
ASA
时间窗: Before surgery
I, II, III, IV
Age
时间窗: Before surgery
Years
Tumor Localization
时间窗: During the operation
Upper/Middle/Low
Pathologic Stage
时间窗: up to 10 days after surgery
1A, 1B, 2A, 2B, 3A, 3B, 3C
Complications
时间窗: Through study completion, an average of 1 year
yes/no
European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30) Functional scales
时间窗: During one week after surgery
Global/Physical/Role/Cognitive/Social functioning. All scales and single-item measurements range from 0 to 100. A higher score on a functional scale indicates better functioning.
European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30) Symptom scales
时间窗: During one week after surgery
Fatigue/Nausea and vomiting/Pain/Dyspnoea/Insomnia/Appetite loss/Constipation/Diarrhoea/Financial difficulties. All scales and single-item measurements range from 0 to 100. A higher score for a symptom scale / item indicates a higher symptomatology and problem level.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal Cancer 29 (EORTC QLQ-CR29) Functional scales
时间窗: During one year after surgery
Body Image/Future projections/Weight/Sexual interest. All scales and single-item measurements range from 0 to 100. A higher score on a functional scale indicates better functioning.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal Cancer 29 (EORTC QLQ-CR29) Symptom scales
时间窗: During one year after surgery
Urinary frequency/Blood and mucus in stool/Stool frequency/Urinary incontinence/Dysuria/Abdominal pain/Buttock pain/Bloating/Dry mouth/Hair loss/Taste/Flatulence/Faecal incontinence/Sore skin/Embarrassment/Impotence/Dyspareunia. All scales and single-item measurements range from 0 to 100. A higher score for a symptom scale / item indicates a higher symptomatology and problem level.
次要结局
未报告次要终点
研究者
Ramazan Sari
Principal Investigator
Dr. Lutfi Kirdar Kartal Training and Research Hospital