Clinical trial NCT06460402: Ice Therapy and Warm Baths for Hemorrhoidectomy Wound Care
Official title: Comparing Ice Therapy and Warm Baths for Hemorrhoidectomy Wound Care
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Post Hemorrhoidectomy Pain
Post Operative Pain
Wound Heal
Keywords: pain
hemorrhoids
Lead sponsor: E-DA Hospital
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, randomized, parallel-group controlled trial comparing the effects of cryotherapy versus warm water sitz baths on post-hemorrhoidectomy wound care. Eligible participants (N=128) will be 1:1 randomized to receive either ice pack applications (cryotherapy group) or warm water sitz baths (control group) after undergoing surgical hemorrhoid excision. The primary outcomes of postoperative pain levels and analgesic consumption, as well as secondary outcomes of wound separation incidence and swelling, will be assessed at various time points. This parallel-group design allows direct comparison of the two interventions to determine if cryotherapy is superior to the current standard of care (sitz baths) in promoting recovery after hemorrhoidectomy.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Postoperative Pain Scores
timeFrame: at 24, 48, and 72 hours post-surgery for pain.
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: E-Da hospital
Study officials:
References: