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临床试验/NCT06460402
NCT06460402Enrolling By Invitation不适用

Comparing Ice Therapy and Warm Baths for Hemorrhoidectomy Wound Care

E-DA Hospital2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
120
试验地点
2
主要终点
Postoperative Pain Scores

研究概览

简要总结

This study aims to compare the effectiveness of cryotherapy and warm water sitz bath in post-hemorrhoidectomy wound care. It is a prospective, randomized controlled trial that will assess the impact of these two methods on postoperative pain, analgesic use, wound separation, and swelling.

详细描述

Background: Hemorrhoids are a common anorectal condition. For patients with severe or intolerable symptoms, surgical excision (hemorrhoidectomy) is an effective treatment. However, postoperative pain, swelling, and wound complications are common issues that may delay recovery. Currently, warm water sitz baths are recommended for pain relief and healing, but some studies suggest cryotherapy may be an effective alternative by reducing inflammation and swelling. This trial aims to systematically compare the effects of these two therapies.

Objectives:

Primary: Assess and compare pain levels (VAS) and total analgesic consumption between the two groups at different postoperative time points.

Secondary: Evaluate and compare wound separation incidence at 1-week follow-up and wound swelling at different time points.

Methods:

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-75 years Diagnosed with symptomatic hemorrhoids requiring surgical removal Able to understand and comply with the trial procedures

排除标准

  • Pregnant or lactating women Known allergy to cold or warm therapy Coagulation disorders or receiving anticoagulant therapy Severe organ dysfunction (cardiac, pulmonary, hepatic, renal, etc.) Immunocompromised or receiving immunosuppressive therapy Other anorectal surgery within the past 1 month Concomitant anorectal diseases (e.g., anal fistula, anal fissure) requiring additional surgical treatment Cognitive impairment, psychiatric illness, or language barrier preventing compliance Currently participating in another clinical trial

结局指标

主要结局

Postoperative Pain Scores

时间窗: at 24, 48, and 72 hours post-surgery for pain.

Pain scores assessed using the Visual Analog Scale (VAS) at 24, 48, and 72 hours after hemorrhoidectomy surgery.

次要结局

未报告次要终点

研究者

发起方
E-DA Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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