Comparison of Postoperative Pain Between Laser Haemorrhoidoplasty and Open Haemorrhoidectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 68
- 主要终点
- Postoperative pain score
研究概览
简要总结
Hemorrhoidal disease is a common condition that can cause symptoms such as rectal bleeding and protrusion of tissue through the anal canal. For patients with symptomatic grade II, III, or IV internal hemorrhoids who require surgery, different surgical techniques are available.
This randomized controlled trial will compare postoperative pain between two surgical treatments for hemorrhoids: laser hemorrhoidoplasty and open Milligan-Morgan hemorrhoidectomy. The study will include adult patients aged 20-50 years with symptomatic grade II, III, or IV internal hemorrhoids who are suitable for elective surgery.
A total of 68 participants will be enrolled and randomly allocated in a 1:1 ratio to either open Milligan-Morgan hemorrhoidectomy or laser hemorrhoidoplasty. Postoperative pain will be assessed using the Visual Analogue Scale (VAS), which ranges from 0 (no pain) to 10 (worst imaginable pain). The primary outcome will be the VAS pain score 24 hours after surgery. Pain will also be assessed 72 hours after surgery as a secondary outcome.
The study will also record the need for rescue analgesia and the total amount of rescue tramadol administered during the first 72 hours after surgery. Relevant postoperative complications will also be monitored.
The purpose of the study is to determine whether there is a difference in postoperative pain between laser hemorrhoidoplasty and open Milligan-Morgan hemorrhoidectomy. The findings may provide locally relevant information regarding postoperative pain and early recovery following these two surgical approaches.
详细描述
Hemorrhoidal disease is associated with symptomatic enlargement and/or prolapse of the anal cushions and is a common anorectal condition. Although many patients can be managed conservatively or with office-based procedures, symptomatic hemorrhoids with persistent symptoms or significant prolapse may require surgical treatment.
Open Milligan-Morgan hemorrhoidectomy is an established surgical treatment for advanced symptomatic hemorrhoidal disease. Its effectiveness is accompanied by postoperative surgical wounds, which may contribute to postoperative pain and delayed recovery. Laser hemorrhoidoplasty is a less invasive, non-excisional technique in which laser energy is delivered submucosally to produce thermal coagulation and subsequent shrinkage of hemorrhoidal tissue.
Previous comparative evidence has suggested that laser hemorrhoidoplasty may be associated with less postoperative pain and reduced analgesic requirements compared with conventional excisional hemorrhoidectomy. However, comparative evidence from South Asian populations remains limited. In addition, the use of laser hemorrhoidoplasty in a high-volume public-sector tertiary care setting involves specialized equipment and consumables, making evaluation of its clinical outcomes in the local setting relevant.
This randomized controlled trial has been designed to directly compare postoperative pain following laser hemorrhoidoplasty and open Milligan-Morgan hemorrhoidectomy. Pain will be evaluated using a standardized Visual Analogue Scale, with assessment performed before administration of scheduled postoperative analgesia to reduce the potential influence of analgesic administration on pain measurement.
The study will also examine postoperative analgesic requirements and relevant postoperative complications. The findings are intended to provide locally relevant clinical evidence regarding postoperative pain and early postoperative recovery following these two surgical approaches.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Adult patients aged 20-50 years. Patients of either sex. Patients diagnosed with symptomatic Grade II, III, or IV internal hemorrhoids based on clinical examination and proctoscopy/anoscopy.
- Patients fit for elective surgery under anesthesia, classified as ASA physical status I or II.
- Patients providing written informed consent to participate in the study.
排除标准
- Pregnant females. Patients with Grade I hemorrhoids or purely external hemorrhoids. Patients presenting with strangulated, thrombosed, or gangrenous hemorrhoids requiring emergency surgical intervention.
- Patients with associated anorectal pathologies, including anal fissure, fistula-in-ano, inflammatory bowel disease, or anorectal malignancy.
- Patients with bleeding diathesis or deranged coagulation profiles, including prolonged PT, APTT, or INR.
- Patients with chronic liver disease or portal hypertension. Patients classified as ASA physical status III or IV. Immunocompromised patients, including those with confirmed HIV infection.
研究组 & 干预措施
Open Milligan-Morgan Hemorrhoidectomy
Participants allocated to this group will undergo open Milligan-Morgan hemorrhoidectomy for symptomatic grade II, III, or IV internal hemorrhoids.
干预措施: Open Milligan-Morgan Hemorrhoidectomy (Procedure)
Laser Hemorrhoidoplasty
Participants allocated to this group will undergo laser hemorrhoidoplasty (LHP) for symptomatic grade II, III, or IV internal hemorrhoids.
干预措施: Laser Hemorrhoidoplasty (Procedure)
结局指标
主要结局
Postoperative pain score
时间窗: 24 hours after surgery (postoperative day 1), before administration of the scheduled postoperative analgesic
Postoperative pain will be assessed using the Visual Analogue Scale (VAS), ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain.
次要结局
未报告次要终点
研究者
Abdul Basit
Postgraduate resident
Allied Hospital Faisalabad
标识符
- NCT 编号
- NCT07846904
- 其他研究编号
- 48.ERC/FMU/2024-25-23
日期
- 首次提交
- (7天前)
- 首次发布
- (昨天)
- 主要完成日期
- (5个月后)
- 研究完成日期
- (5个月后)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
Individual participant-level data will not be shared with other researchers because no data-sharing plan has been established for this study. Study data will be used for the planned statistical analysis and reporting of the study findings.