Ice Therapy and Warm Baths for Hemorrhoidectomy Wound Care
- Conditions
- Post Hemorrhoidectomy PainPost Operative PainWound Heal
- Registration Number
- NCT06460402
- Lead Sponsor
- E-DA Hospital
- Brief Summary
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.
- Detailed Description
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:
Design: Prospective, randomized, parallel-controlled trial with 1:1 allocation. Subjects: 128 symptomatic hemorrhoid patients (18-75 years old) undergoing hemorrhoidectomy, randomized into cryotherapy or sitz bath group.
Intervention: Cryotherapy group - ice packs for 20 min every 2h within 48h post-op. Sitz bath group - warm water baths 2-3 times daily for 15-20 min.
Outcome measures: Pain VAS scores, analgesic consumption, wound separation rate, swelling assessment at different time points.
Expected results and benefits: Cryotherapy is hypothesized to result in lower pain scores, reduced analgesic use, lower wound separation incidence and milder swelling compared to sitz baths. This may lead to improved postoperative recovery and quality of life for patients.
Risks and management: Potential mild adverse reactions like skin irritation, temporary nerve stimulation will be closely monitored and appropriately managed. The study will be terminated for any severe adverse events.
Statistical analysis: Repeated measures ANOVA for VAS scores and analgesic use. Chi-square or Fisher's exact test for wound separation rates. Descriptive statistics for baseline characteristics.
In summary, this well-designed randomized control trial aims to provide high-quality evidence comparing cryotherapy and sitz baths in post-hemorrhoidectomy care, potentially identifying a superior treatment option to improve patient outcomes and experiences.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 120
Age 18-75 years Diagnosed with symptomatic hemorrhoids requiring surgical removal Able to understand and comply with the trial procedures
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Postoperative Pain Scores 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
E-Da hospital
🇨🇳Kaohsiung, Taiwan
E-Da hospital🇨🇳Kaohsiung, Taiwan