Ice Packing Versus Warm Sitz Baths After Ferguson Hemorrhoidectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Mean Postoperative Pain Score During Postoperative Days 1-7
研究概览
简要总结
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.
详细描述
This prospective, two-center, parallel-group randomized controlled trial included eligible patients undergoing closed Ferguson hemorrhoidectomy at Istanbul Okan University Health Center and Uskudar University-Memorial Atasehir Hospital between September 2024 and April 2026. Participants were randomly assigned in a 1:1 ratio using a computer-generated allocation sequence.
Participants assigned to the ice-packing group received covered cold gel packs 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. Participants assigned to the warm sitz bath group used warm water sitz baths for 5 minutes, four times daily, for 7 days.
All participants underwent the same Ferguson hemorrhoidectomy technique and received a standardized postoperative analgesic regimen, bowel management protocol, and wound care instructions. Because of the nature of the interventions, participants and the clinical personnel providing treatment instructions could not be blinded. Outcome assessments were performed by surgeons who were not involved in administering the postoperative interventions, and the data analysts were blinded to treatment allocation.
The primary outcome was the mean pain score during postoperative days 1 through 7. Pain was evaluated using the Wong-Baker FACES Pain Rating Scale. Secondary outcomes included perianal swelling assessed on postoperative days 1, 3, and 7; early wound status assessed using the REEDA scale on postoperative day 7; rescue analgesic use; and adverse events. Participants were followed for 7 days after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Ice Packing
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.
干预措施: Cryotherapy (Ice Packing) (Other)
Warm Sitz Bath
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.
干预措施: Warm Sitz Bath (Other)
结局指标
主要结局
Mean Postoperative Pain Score During Postoperative Days 1-7
时间窗: Postoperative days 1 through 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.
次要结局
- 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)
研究者
Murat Ferhat Ferhatoğlu
MD
Memorial Atasehir Hospital