Prospective Randomized Study on Postoperative Pain in the Surgical Treatment of Hemorrhoids Through Conventional Hemorrhoidectomy With a Monopolar Electric Scalpel or Bipolar Energy With Caiman® (Aesculap®)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Visual analogue scale (VAS)
研究概览
简要总结
To demonstrate that postoperative pain secondary to Milligan and Morgan hemorrhoidectomy with Caiman® (AESCULAP®) and subsequent oral conventional analgesia is at least not greater than that generated after hemorrhoidectomy with monopolar diathermy and intravenous analgesia with care home at discharge.
详细描述
In the treatment of coloproctological pathology, one of the most important problems is postoperative pain. Especially in the management of hemorrhoids treatment. There are different approaches but in all of them pain is the predominant symptom.
There are some less painful techniques but the gold standard continues to be hemmorrhoidectomy, which is associated with postoperative pain. Some actions have been taken to control pain to avoid the admission of patients, but there are still problems in this regard.
Our group aims to study the effect of energy change for performing hemorrhoidectomy on postoperative pain.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients with 2 or 3 bundles of grade III-IV hemorrhoids (Goligher classification) clinically symptomatic and subject to outpatient hemorrhoidectomy
- •Voluntary participation.
- •ASA I-II-III.
排除标准
- •Failure to meet the inclusion criteria.
- •Allergic to Paracetamol, derivatives of morphine.
- •Allergic to NSAIDs.
- •Synchronous colorectal neoplasia.
- •Coagulation disorders.
- •Thrombosed hemorrhoid.
- •Inflammatory bowel disease.
- •Liver cirrhosis and/or portal hypertension.
- •Pregnant women.
- •Difficulty following up by phone and/or in person.
结局指标
主要结局
Visual analogue scale (VAS)
时间窗: 6 hours of post-operative period (before hospital discharge performed); within 2 days with telephone control; at 7 days control at external consultations; at 30 days control at external consultations
Postoperative pain: value 0 (no pain) - 10 (maximum pain)
次要结局
- Wound healing time(7 days postoperative control at external consultations; 30 days postoperative control at external consultations)
- Post-surgery satisfaction survey(30 days postoperative control at external consultations)
- Wexner scale(in pre-operative visit, on the 7th and 30th postoperative clinical control)
- Number of emergency consultations(in 30 days post-surgery)
- Collection of adverse effects from patients(in 30 days post-surgery)
研究者
Laura Mora-Lopez
PhD, MD, Colorrectal Surgeon, Associate Professor
Corporacion Parc Tauli