Ice Therapy and Warm Baths for Hemorrhoidectomy Wound Care

NCT06460402 | Enrolling By Invitation DMC

• 1 other identifier: EMRP23113N
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Hemorrhoidectomy Pain; Post Operative Pain; Wound Heal

Keywords

pain; hemorrhoids

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

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.

Other: Ice packing

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.

Other: Warm sitz bath

Interventions

Ice packing 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.

Ice packing

Warm sitz bath 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.

Warm sitz bath

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• E-DA Hospital: lead

Study Sites (1)

E-Da hospital

Kaohsiung City, 812, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 40145987 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Pain; Hemorrhoids

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 14, 2024
• Study Start: May 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: July 1, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)