Ice Therapy and Warm Baths for Hemorrhoidectomy Wound Care

NCT ID: NCT06460402

Last Updated: 2024-06-14

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-07-01

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.

Conditions

Post Hemorrhoidectomy Pain; Post Operative Pain; Wound Heal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ice packing

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.

Group Type: EXPERIMENTAL

Ice packing

Intervention Type: OTHER

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 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.

Group Type: ACTIVE_COMPARATOR

Warm sitz bath

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

E-DA Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

E-Da hospital

Kaohsiung City, , Taiwan

Countries

Taiwan

References

Chen PC, Kao YK, Yang PW, Chen CH, Chen CI. Ice Packing Versus Warm Sitz Baths for Post-hemorrhoidectomy Pain Management: A Randomized Controlled Trial. Dis Colon Rectum. 2025 Jul 1;68(7):865-874. doi: 10.1097/DCR.0000000000003707. Epub 2025 Mar 27.

Reference Type: DERIVED

PMID: 40145987 (View on PubMed)

Other Identifiers

EMRP23113N

Identifier Type: -

Identifier Source: org_study_id