Ice Therapy and Warm Baths for Hemorrhoidectomy Wound Care

Post Operative Pain Clinical Trial

Official title:

Comparing Ice Therapy and Warm Baths for Hemorrhoidectomy Wound Care

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06460402
• Other study ID #: EMRP23113N
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: June 2024
• Source: E-DA Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: July 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain
• Wound Heal
• Wounds and Injuries

Intervention

Other:
• Ice packing
For both arms, participants will self-administer interventions at home per instructions: ice packs every 2 hours for 48 hours (ice pack arm) or sitz baths 2-3 times daily for 7 days (warm water arm). Standardized supplies and daily logs will be provided. All participants receive standard postop care with analgesics and wound care. Adverse events will be monitored closely. Intervention duration: 48 hours (ice), 7 days (sitz bath). Assessments: baseline, 24/48/72 hours (pain, swelling), 1 week (wound separation). Total study duration per participant: ~1 week from surgery.
• Warm sitz bath
Participants in this arm will receive standard instructions to perform warm water sitz baths at home, starting from the day of surgery and continuing for 7 days postoperatively. They will be advised to take 2-3 sitz baths per day, with each bath lasting for 15-20 minutes. A standard plastic sitz bath basin will be provided to the participants, along with a thermometer to monitor the water temperature. The recommended water temperature range for the sitz baths is 37-40°C (98.6-104°F). Participants will be instructed to keep a daily log recording the number of sitz baths taken, the duration of each bath, and the water temperature. Proper hygiene and wound care instructions will also be provided to prevent infection.

Locations

Country	Name	City	State
Taiwan	E-Da hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
E-DA Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Pain Scores	Pain scores assessed using the Visual Analog Scale (VAS) at 24, 48, and 72 hours after hemorrhoidectomy surgery.	at 24, 48, and 72 hours post-surgery for pain.