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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 Hospital1 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
干预措施

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
1
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
否

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

研究组 & 干预措施

Ice packing

Experimental

Participants in this arm will receive cryotherapy in the form of ice pack applications to the perianal area for 20 minutes every 2 hours during the first 48 hours after hemorrhoidectomy. The ice packs will be applied externally to the surgical site to reduce pain, swelling, and inflammation. Participants will be instructed on proper ice pack application techniques and will be provided with the necessary supplies. Postoperative pain levels, analgesic consumption, wound healing, and other outcomes will be assessed at various time points.

干预措施: Ice packing (Other)

Warm sitz bath

Active Comparator

Participants in this arm will receive warm water sitz baths as the standard postoperative care after hemorrhoidectomy. They will be instructed to sit in a bathtub or a special sitz bath basin filled with warm water for 15-20 minutes, 2-3 times daily, starting from the first postoperative day. The warm water is believed to promote blood flow, relax the anal sphincter, and soothe the perianal area, potentially aiding in pain relief and wound healing. Participants will be provided with instructions on proper sitz bath techniques and will be assessed for postoperative pain, analgesic consumption, wound healing, and other outcomes at various time points, similar to the cryotherapy arm.

干预措施: Warm sitz bath (Other)

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 (1)

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