Effect of Cryotherapy on Postoperative Pain After Hemorrhoidectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Pain at rest and after defecation at At day 1 postoperatively
研究概览
简要总结
This prospective, patient-blinded randomized controlled trial will be conducted at Kasr Al-Ainy Hospital, Cairo University. Adult patients with grade III or IV hemorrhoids undergoing elective surgery will be randomized (1:1) to either conventional hemorrhoidectomy or hemorrhoidectomy followed by intra-anal cryotherapy. All patients will undergo standardized preoperative assessment and receive the same postoperative analgesia and care. Postoperative pain will be assessed using the Visual Analogue Scale (VAS), with follow-up at postoperative day 2 and at 1, 2, 3, and 4 weeks.
详细描述
This prospective, patient-blinded randomized controlled trial will be conducted at the General Surgery Department, Kasr Al-Ainy Hospital, Cairo University. Adult patients (≥18 years) with grade III or IV hemorrhoids who are scheduled for elective surgery will be enrolled. Patients with concomitant anorectal pathology, inflammatory bowel disease, impaired continence, or those requiring synchronous procedures will be excluded.
Following informed consent, all patients will undergo standardized preoperative clinical assessment and routine laboratory investigations, with colonoscopy performed when clinically indicated. Participants will be randomized in a 1:1 ratio using computer-generated randomization with allocation concealment by sequentially numbered, opaque, sealed envelopes into either conventional Milligan-Morgan hemorrhoidectomy (control group) or Milligan-Morgan hemorrhoidectomy followed by intra-anal cryotherapy (cryotherapy group). In the cryotherapy group, a sterile ice pack will be inserted into the anal canal for 1 minute immediately after completion of hemorrhoidectomy.
Postoperative management will be standardized in both groups, including analgesia, local care, antibiotics, and laxatives. Postoperative Pain will be assessed using the Visual Analogue Scale (VAS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Patients with with third or fourth degree haemorrhoids for elective Haemorrhoidectomy and their age greater than 18 years old.
排除标准
- •Concurrent anal pathology (e.g., anal fissure, fistula, )
- •Patients planned for synchronous procedures
- •Patients with inflammatory bowel disease
- •Patients with impaired anal sphincter function or fecal incontinence
研究组 & 干预措施
Miligan-Morgan haemorroidectomy with Crytherapy
Patients will be conducted to Miligan-Morgan haemorroidectomy with intraoperative Crytherapy
干预措施: Milligan-Morgan Hemorrhoidectomy with Cryotherapy (Procedure)
Miligan-Morgan haemorroidectomy
Patients will be conducted to Milligan-Morgan Hemorrhoidectomy
干预措施: Miligan-Morgan haemorroidectomy (Procedure)
结局指标
主要结局
Pain at rest and after defecation at At day 1 postoperatively
时间窗: At day 1 postoperatively
Assessment of pain at rest and after defecation at postoperative day 1 in both treatment groups using Visual Analogue Scale (Visual Analogue Scale for Pain: ranges from 0 to 10 . Higher scores indicate a worse outcome {greater pain intensity})
次要结局
- Number of participants requiring rescue analgesia within the first 24 hours postoperatively(within the first 24 hours postoperatively)
- Pain during rest and after defecation at postoperative day 2,7,14 and 28(At day 2, day 7, day 14 and day 28 postoperatively)
- Number of participants with surgical site infection(Up to 30 days postoperatively)
- Number of participants with Postoperative bleeding in both groups(Up to 30 days postoperatively)
- Hospitalization period(From date of hospital admission until date of hospital discharge, assessed up to 10 days after surgery)
- Post operative urine retention(Within 48 hours postoperatively)
研究者
Ahmed Mohamed Abdelaal
Lecturer
Cairo University