Do We Need Fluid Restriction After Stapled Hemorrhoidopexy? A Pilot, Double-Blinded, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- first urination
研究概览
简要总结
BACKGROUND: Conventional hemorrhoidectomy leads to a high urinary retention rate and fluid restriction is commonly recommended to minimize complications. However, the need for postoperative fluid restriction among patients who have undergone stapled hemorrhoidopexy is unclear. We aimed to determine whether fluid restriction after stapled hemorrhoidopexy with/without partial external hemorrhoidectomy could reduce urinary retention and postoperative pain.
PATIENTS AND METHODS: In this prospective, double-blinded, randomized controlled trial, we enrolled patients who had grade III or IV hemorrhoids and underwent stapled hemorrhoidopexy with/without partial external hemorrhoidectomy; 250 mL/12 h of sterile 0.9% saline was administered to the fluid restriction group after the operation, and 1000 mL/12 h was given to the non-fluid-restriction group. We focused on the need for fluid restriction after stapled hemorrhoidopexy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gr. III-IV hemorrhoids paitents
排除标准
- •Age<20 or >80
- •Allergy to NSAID or opoids
- •Impaired renal function
- •Pregnant or breast feeding
研究组 & 干预措施
Fluid restriction
Within 12 h of surgery, the experimental group received 1000 mL 0.9% sterile saline intravenously.
干预措施: 1000 mL 0.9% sterile saline (Drug)
Non-fluid restriction
Within 12 h of surgery, the control group received 250 mL 0.9% sterile saline intravenously
干预措施: 250 mL 0.9% sterile saline (Drug)
结局指标
主要结局
first urination
时间窗: 1 day
the time to first urination after surgery
次要结局
未报告次要终点
研究者
Yi-Chiao Cheng
Division of Colon and Rectal Surgery, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center
Tri-Service General Hospital
