Comparison of Clinical Effects Between Routine and High-frequency Follow-up After Hemorrhoids Surgery: a Single-center, Prospective, Open-label, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Quality-of-life SCORES
研究概览
简要总结
This study aims to investigate whether frequent follow-ups can enhance the quality of life of patients after hemorrhoid surgery and reduce the incidence of complications. A total of 116 eligible patients were randomly and evenly divided into two groups (58 patients in each group): A. The control group: Patients received routine health education services upon discharge and were then followed up by phone at the regular frequency. B. The high-frequency group: Patients received routine health education services upon discharge and were then followed up by phone at a higher frequency. The quality of life of the patients and the incidence of complications were compared to evaluate the clinical effects of different intervention measures. The main hypothesis is that compared to conventional care, frequent follow-ups can significantly improve the quality of life of patients, promote wound healing, and reduce the incidence of complications and disease recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old < age < 75 years old;
- •Mixed hemorrhoids were diagnosed;
- •Internal hemorrhoids ligation + external hemorrhoidectomy
- •Complete hospital records;⑤voluntary cooperation in the study
排除标准
- •The patient had mental illness;
- •Serious underlying diseases;
- •pregnant or lactating women;
- •Serious complications and drug allergy occurred during the treatment;
- •Communication difficulties
研究组 & 干预措施
Conventional group
Patients received routine health education services at discharge and were enrolled in the sample data collection cluster. Patients were followed up by telephone by trained medical and nursing teams at 1 week and 1 month after discharge, and then every 3 months until the end of the one-year follow-up period
High frequency group
Patients received routine health education services at discharge and were enrolled in the sample data collection cluster. Patients were followed up by telephone by a trained medical team at 1, 2, 3, and 4 weeks after discharge, and then every month until the end of the one-year follow-up period.
干预措施: High frequency follow-up (Behavioral)
结局指标
主要结局
Quality-of-life SCORES
时间窗: Baseline, weeks 2, 4, 12, 24, 48
By evaluating the quality of life of patients, we proved the effectiveness of different frequency of follow-up methods in improving the quality of life of patients after hemorrhoids surgery.
次要结局
- pain score(Baseline, Day 7, 14, 21, 28)
- Complication incidence(Within six months after discharge)
- patient satisfaction(Baseline, weeks 2, 4, 12, 24, 48)