Effect of Anal Lift Exercise on Rehabilitation After Anal Fistula 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
- 124
- 试验地点
- 1
- 主要终点
- Record pain score
研究概览
简要总结
This prospective randomized controlled study aims to include patients who have undergone anal fistula surgery, to observe the impact of early postoperative pelvic floor muscle training combined with dietary intervention on postoperative pain, bleeding, anal distension and defecation function, with the goal of clarifying the value of early rehabilitation intervention in the recovery after anal fistula surgery, and providing a reference for optimizing postoperative management plans in clinical practice.
详细描述
This study is a single-center prospective randomized controlled clinical trial, which plans to include 124 patients aged 18 to 75 years who are scheduled to undergo anal fistula surgery. They will be randomly assigned in a 1:1 ratio to the observation group and the control group. The control group will receive the conventional postoperative management plan, including dressing changes, anti-infection treatment, pain relief, and basic dietary guidance. The observation group, on the other hand, will, in addition to the above, undergo standardized pelvic floor muscle training and postoperative dietary control intervention from the day of surgery to the fifth postoperative day. The pain score, bleeding score, and anal distension and fullness score of the patients in both groups will be continuously collected on the first, second, third, fourth, and fifth postoperative days. At the same time, the related indicators of defecation will be observed and recorded. The aim is to systematically evaluate the clinical effect of early postoperative pelvic floor muscle training combined with dietary management on pain relief, bleeding control, improvement of anal distension and fullness, and recovery of defecation function in patients after anal fistula surgery, providing high-quality evidence-based basis for formulating more optimized and targeted early rehabilitation management plans after anal fistula surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 55 years old
- •Patients diagnosed with anal fistula through digital rectal examination and anoscopy
- •Receive operation
排除标准
- •The patient has a mental disorder.
- •Patients with hemorrhoids
- •Anal fistula combined with perianal abscess
- •Patients who are unable to cooperate with follow-up visits
研究组 & 干预措施
Observation group
Explain the relevant postoperative precautions and instructions to the patients, and the observation group is allowed to perform random movements.
Control group
Explain the relevant postoperative precautions and instructions to the patients, and have the control group perform pelvic floor contraction exercises.
干预措施: Kegel exercises (Procedure)
结局指标
主要结局
Record pain score
时间窗: Day 1,2,3,4,5
Assessment timepoints: At postoperative days 1, 2, 3, 4, 5.Pain: 0 points, no pain; 1 point, mild pain, tolerable; 2 points, obvious pain, requiring painkillers; 3 points, severe pain, requiring injection of painkillers.The higher the score, the more severe the anxiety.
Record the bleeding score.
时间窗: Day 1,2,3,4,5
Assessment timepoints: At postoperative days 1, 2, 3, 4, 5.Bleeding: 0 points, no bleeding; 1 point, a little blood in the stool; 2 points, more blood dripping from the stool, which can be relieved by hemostasis; 3 points, heavy bleeding, requiring suture and ligation for hemostasis.The higher the score, the more severe the anxiety.
Record the score of anal distension and fullness.
时间窗: Day 1, 2, 3, 4, 5
Assessment timepoints: At postoperative days 1, 2, 3, 4, 5.Anal distension: 0 points, none; 1 point, slight distension; 2 points, obvious distension, affecting movement; 3 points, severe distension, unbearable. The higher the score, the more severe the anxiety.
次要结局
- Compare the defecation situation of the patients.(Within 30 days postoperatively)
- Length of hospital stay(Daily from Day 1 (max 60 days post-op))
