跳至主要内容
临床试验/NCT04459039
NCT04459039已完成不适用

Do We Need Fluid Restriction After Stapled Hemorrhoidopexy? A Pilot, Double-Blinded, Randomized Controlled Trial

Tri-Service General Hospital1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2018年2月1日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yi-Chiao Cheng

Division of Colon and Rectal Surgery, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center

Tri-Service General Hospital

研究点 (1)

Loading locations...

相似试验