Ice Packing Versus Warm Sitz Baths After Hemorrhoidectomy

NCT07843563 | Completed DMC

• 1 other identifier: 37
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

Warm sitz baths are commonly recommended after hemorrhoidectomy, although their benefit for early postoperative recovery remains uncertain. Local cold application may reduce postoperative pain and perianal swelling. This prospective, two-center, randomized controlled trial compared ice packing with warm sitz baths in patients undergoing Ferguson hemorrhoidectomy. Participants were randomly assigned in a 1:1 ratio to receive either postoperative ice packing or warm sitz baths for 7 days. Both groups received the same surgical technique, analgesic regimen, bowel management, and wound care protocol. The primary outcome was the mean postoperative pain score during postoperative days 1 through 7. Secondary outcomes included perianal swelling, early wound status assessed using the REEDA scale, rescue analgesic use, and adverse events. The study aimed to determine whether ice packing provides better early postoperative recovery than warm sitz baths without increasing adverse events.

Conditions

Hemorrhoids; Postoperative Pain

Keywords

Ferguson Hemorrhoidectomy; Ice Packing; Cryotherapy; Warm Sitz Bath; Perianal Edema; Wound Healing; REEDA Scale

Outcome Measures

Primary Outcomes (1)

• Mean Postoperative Pain Score During Postoperative Days 1-7

  Pain was assessed using the Wong-Baker FACES Pain Rating Scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Daily pain scores recorded during postoperative days 1 through 7 were averaged for each participant. Lower scores indicate less pain.

  Postoperative days 1 through 7

Secondary Outcomes (3)

• Perianal Swelling Score

  Postoperative days 1, 3, and 7

• Early Wound Status Assessed Using the REEDA Scale

  Postoperative day 7

• Rescue Analgesic Use

  From surgery through postoperative day 7

Study Arms (2)

Ice Packing

EXPERIMENTAL

Participants underwent standardized Ferguson hemorrhoidectomy and received postoperative ice packing applied to the perianal region. During hospitalization, covered cold gel packs were applied for 15 minutes every hour while the participant was awake. After discharge, participants continued ice packing for 10 minutes every hour while awake for 7 days.

Other: Cryotherapy (Ice Packing)

Warm Sitz Bath

ACTIVE COMPARATOR

Participants underwent standardized Ferguson hemorrhoidectomy and received postoperative warm sitz baths. Participants used a standard plastic sitz bath filled with warm water for 5 minutes, four times daily, for 7 days.

Other: Warm Sitz Bath

Interventions

Cryotherapy (Ice Packing) OTHER

Two 13 × 13 cm cold gel packs covered with disposable protective sleeves were folded into a U-shape and applied to the perianal region. During hospitalization, the packs were applied for 15 minutes every hour while the participant was awake. After discharge, participants continued the application for 10 minutes every hour while awake for 7 days.

Ice Packing

Warm Sitz Bath OTHER

Participants used a standard plastic sitz bath filled with fresh warm water at approximately their usual showering temperature. Each application lasted 5 minutes and was performed four times daily for 7 days.

Warm Sitz Bath

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 years or older.
• Primary hemorrhoidal disease requiring Ferguson hemorrhoidectomy.
• American Society of Anesthesiologists (ASA) physical status class I or II.
• Ability to understand the study instructions, provide written informed consent, and comply with the assigned postoperative intervention and follow-up schedule.

You may not qualify if:

• Recurrent hemorrhoidal disease.
• Concurrent anal pathology, including anal fistula, anal fissure, or anal polyp.
• History of chronic pain.
• Regular analgesic use.
• Cognitive impairment that could interfere with pain assessment or adherence to the study protocol.
• Documented allergy or intolerance to the study materials.
• Additional surgical procedures performed together with Ferguson hemorrhoidectomy.
• Comorbidities that could affect pain perception or the postoperative course, including diabetes mellitus, liver cirrhosis, inflammatory bowel disease, documented neuropathy, or coagulation disorders.
• ASA physical status class III or higher.

Sponsors & Collaborators

• Memorial Atasehir Hospital: lead

Study Sites (1)

Memorial Atasehir Hospital

Istanbul, Kadıköy, 34734, Turkey (Türkiye)

Location

Related Publications (2)

• Seow-En I, Chen LRH, Zhao Y, Ng YY, Tan EK. Cryotherapy reduces pain post-hemorrhoidectomy (CYPHER): a randomized, controlled, superiority trial of intra-anal ice after surgery for grade III hemorrhoids. Ann Coloproctol. 2025 Dec;41(6):537-544. doi: 10.3393/ac.2025.00549.0078. Epub 2025 Dec 24.

  PMID: 41486911 BACKGROUND

• Hawkins AT, Davis BR, Bhama AR, Fang SH, Dawes AJ, Feingold DL, Lightner AL, Paquette IM; Clinical Practice Guidelines Committee of the American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Hemorrhoids. Dis Colon Rectum. 2024 May 1;67(5):614-623. doi: 10.1097/DCR.0000000000003276. Epub 2024 Jan 31. No abstract available.

  PMID: 38294832 RESULT

MeSH Terms

Conditions

Hemorrhoids; Pain, Postoperative

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding of participants and care providers was not feasible because of the nature of the interventions. Outcome assessments were performed by surgeons who were not involved in administering the postoperative interventions; however, complete blinding of outcome assessors could not be guaranteed. Data analysts were blinded to treatment allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Participants were randomly assigned in a 1:1 ratio to two parallel postoperative care groups: ice packing or warm sitz baths.

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 28, 2026
• Study Start: September 1, 2024
• Primary Completion: April 1, 2026
• Study Completion: June 1, 2026
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)