Hemorrhoidectomy Using the Enseal Device: A Comparison to Open Hemorrhoidectomy Techniques
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Post-operative complications
研究概览
简要总结
The purpose of this study is to examine the advantages and disadvantages of using the EnSeal device in hemorrhoid surgery as compared to traditional hemorrhoid surgery techniques.
It is hypothesized that the use of the Enseal device will demonstrate an improvement a patient's overall experience through less postoperative bleeding and pain, decreased time for wound healing, and a faster return to work.
详细描述
The EnSeal Device is FDA approved for surgery in ligating and dividing vascular tissue during abdominal surgery. Electrical energy is converted into heat energy and resultant simultaneous division of tissues. This allows surgery to be bloodless and sutureless. It has been successfully used by many individual practitioners for hemorrhoidectomy, with apparent advantage and success; but to date, no comparative study has been done to assess the advantages and disadvantages of this method of hemorrhoidectomy, when compared to traditional excisional techniques. The investigators propose to use this device in the current study in the treatment of hemorrhoidal disease where vascular tissue is excised in bloodless and sutureless fashion. It is currently being used in institutions throughout the United States and Europe.
After surgery, patients will receive the same standard postoperative instructions as for conventional hemorrhoidectomy, which include wound care, pain medicine, and other standard instructions. The patient will be followed in the office with visits at 3 to 4weeks, and 3 months postoperatively.
At these visits, they will be assessed for postoperative complications including but not limited to: bleeding, urinary retention, fecal impaction, hospital re-admission and pain. Delayed complications -greater than four weeks- will be followed including impaired healing, constipation, abscess, fistula formation, fissure, and stenosis. The patient's pain score and type and amount of pain medications taken will be recorded by the patient daily for the first 2 weeks then weekly for a month postoperatively. This will be assessed using a pain diary which includes a visual analog pain scale (allowing the patient to describe their pain level on a scale between 1 and 10) and space to note the quantity of pain medications used. During each office visit, the operating surgeon will evaluate the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women between ages 18 through 80
- •American Society of Anesthesiologists (ASA) level I, II and III
- •External hemorrhoids must be present and deemed sufficiently symptomatic to warrant removal
- •Internal hemorrhoids at least Grade II
- •Must be able to be seen post-operatively by the surgeon at 3 to 4 weeks and 3 months after surgery
排除标准
- •American Society of Anesthesiologists (ASA) level IV
- •Grade I internal hemorrhoids
- •Currently receiving coumadin, plavix, or other anticoagulants
- •No prior sphincterotomy, drainage of abscess, fistulotomy, or similar procedures
- •No pregnant women at the time of surgery
- •No lactating women
- •No inflammatory bowel disease
- •No history of chronic, active hepatitis B, C, or HIV infection
- •No prior chronic narcotic use (more than 30 days)
研究组 & 干预措施
EnSeal Device
EnSeal Trio Tissue Sealing Device
干预措施: EnSeal Trio Tissue Sealing Device (Device)
结局指标
主要结局
Post-operative complications
时间窗: 3 to 4 weeks
Patients will be assess for postoperative complications including but not limited to: bleeding, urinary retention, fecal impaction, hospital re-admission and pain.
次要结局
- Delayed Post-Operative Complications(3 months)
- Post-Operative Pain(1 month)