Cryotherapy Post-haemorrhoidectomy (CYPHER) Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Pain score on postoperative day 1 after hemorrhoidectomy
研究概览
简要总结
Haemorrhoids is a common problem with an estimated prevalence of 5 to 36%. Surgery is indicated in patients with grade 3 to 4 piles and in patients whom conservative measures have failed. There have been several surgical techniques described such as the Milligan- Morgan, Ferguson haemorrhoidectomy, stapled and laser haemorrhoidectomy. However, most patients experience different degrees of postoperative pain which may cause anxiety and dissatisfaction.
A relatively non-invasive and cost-effective technique targeting inflammation is cryotherapy which has been shown to decrease pain secondary to trauma, injury or disease. Cryotherapy has few deleterious side effects due to its non-pharmacologic nature and has become widespread in sports medicine to treat soft tissue damage.
Therefore, we aim to evaluate the role of cryotherapy in improving postoperative pain and outcomes among patients who undergo haemorrhoidectomy.
详细描述
Haemorrhoids is a common problem with an estimated prevalence of 5 to 36%. Surgery is indicated in patients with grade 3 to 4 piles and in patients whom conservative measures have failed. There have been several surgical techniques described such as the Milligan- Morgan, Ferguson haemorrhoidectomy, stapled and laser haemorrhoidectomy. However, most patients experience different degrees of postoperative pain which may cause anxiety and dissatisfaction.
Pain is an unavoidable side effect of any proctology operation. It arises from local inflammation in traumatized tissues which may cause stimulation of surrounding nociceptors. While adequate postoperative analgesia promotes patient recovery and satisfaction, narcotics for postoperative pain are also associated with numerous side effects.
A relatively non-invasive and cost-effective technique targeting inflammation is cryotherapy which has been shown to decrease pain secondary to trauma, injury or disease. Cryotherapy has few deleterious side effects due to its non-pharmacologic nature and has become widespread in sports medicine to treat soft tissue damage. Ice therapy has previously been shown to be safe and effect for postoperative analgesia in various procedures such as laparotomy, hernia repair, tonsillectomy, oral surgery but the evidence for its role in haemorrhoidectomy is lacking.
Therefore, we aim to evaluate the role of cryotherapy in improving postoperative pain and outcomes among patients who undergo haemorrhoidectomy. We hypothesize that intraoperative trans-anal ice pack insertion for patients after haemorrhoidectomy (conventional & stapled) will have lower postoperative pain scores with possibly decreased postoperative complications.
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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age group of patients: 21 to 75 years old
- •Grade 3 (prolapsed but reducible manually) and Grade 4 (prolapsed but irreducible) piles that are symptomatic
- •Patients recruited are to undergo either staple or conventional (Milligan-Morgan or Ferguson) haemorrhoidectomy
排除标准
- •Grade 1 and 2 haemorrhoids
- •Thrombosed, irreducible piles that require emergency haemorrhoidectomy
- •Patients who had undergone any previous anorectal surgery within 5 years from the date of recruitment
- •Patients with concurrent anorectal pathology (anal fissures, abscess, fistula, tumour, inflammatory bowel disease)
- •Pregnant women
- •Patients with severe medical comorbidities or assessed as ASA 3 and above
- •Patients on long term antiplatelets (aspirin, plavix) and anticoagulation (clexane, warfarin, rivaroxaban, apixaban)
结局指标
主要结局
Pain score on postoperative day 1 after hemorrhoidectomy
时间窗: Postoperative day 1
Pain score on postoperative day from scale of 1 to 10 after hemorrhoidectomy.
次要结局
- Mean time to return to work or regular activity, in days, reported by the patient.(Within the first 90 days after the surgery)
- Changes in the mean pain score 1 month after surgery assessed by telephone interviews on POD1, 2, 3, 4, 7, 14, 21 and 28.(Postoperative day 1, 2, 3, 4, 7, 14, 21 and 28.)
- Postoperative complications after hemorrhoidectomy(Within 30 days after surgery)
- Proportion of patients who had admission after day surgery or readmission for postoperative complications(Within 30 days after surgery)
- Proportion of patients who require repeat surgical interventions for postoperative complications: bleeding, perianal sepsis and anal stenosis(Within 30 days after surgery)