A Multi Center Clinical Trial of the Efficacy and Safety of Rph With the Simplified Milligan-Morgan Surgery on Treatment of Mixed Hemorrhoids
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 3,000
- 试验地点
- 12
- 主要终点
- anal pain
研究概览
简要总结
Simplified Milligan-Morgan is a surgical option which was improved and developed by Professor He,well-known traditional Chinese doctor from Hunan province,based on Milligan-Morgan.RPH is a new therapy for hemorrhoid following the improvement of rubber band ligation.RPH +Simplified Milligan-Morgan is one of important means of modern surgery.The operation method was improved and developed on the basis of Chinese medicine traditional loop ligature and it also embodies uniqueness and advantage of the treatment of mixed hemorrhoids combined traditional Chinese and Western Medicine.The study intends to compare five surgery ways through 3000 cases of patients with mixed hemorrhoid from 12 hospitals,observing the efficacy and safety of various operative methods.Exploration of RPH + Simplified Milligan-Morgan operation indication, contraindication, operation steps and key points, and the operation complications and sequelae and treatment etc provide evidence of evidence-based medicine for Clinical application.
详细描述
RPH is a new therapy for hemorrhoid following the improvement of rubber band ligation.RPH +Simplified Milligan-Morgan is one of important means of modern surgery.The operation method was improved and developed on the basis of Chinese medicine traditional loop ligature and it also embodies uniqueness and advantage of the treatment of mixed hemorrhoids combined traditional Chinese and Western Medicine.The study intends to compare five surgery ways through 3000 cases of patients with mixed hemorrhoid from 12 hospitals,observing the efficacy and safety of various operative methods.Exploration of RPH + Simplified Milligan-Morgan operation indication, contraindication, operation steps and key points, and the operation complications and sequelae and treatment etc provide evidence of evidence-based medicine for Clinical application.
Diagnosis of all mixed hemorrhoids included in this study were performed according to"TCM anorectal diseases treatment guidelines" (2012 Edition) issued and implemented by the China Association of traditional Chinese Medicine .In all cases, the sub center for the unit, stratified by gender, age and disease.In every layer all cases were divided into 5 groups with random number table.Take balance check when test cases reach 80% of a predetermined number .If unbalanced index is larger , the following cases should be assigned according to the principle of the imbalance index reduction.All the cases were assigned to five groups in accordance with experiment design methods of random, contrast ,balance, parallel, and multicenter.Each sub center, each test group has 50 patients.
All the cases involved conducted corresponding preoperative examination and evaluation, respectively using 5 kinds of predetermined operation after grouping.Patients are in strict accordance with the "gynecology of traditional Chinese medicine" (Second Edition) for perioperative treatment in the preoperative, intraoperative and postoperative .
Observation indexes of this study include:General observation index,effective observation index,Safety observation index and severe adverse events.All the data use Excel to establish the data set ,analyzed by SPSS21.0.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- 否
入选标准
- •Conform to the diagnosis standard of mixed hemorrhoid
- •Internal hemorrhoids indexing for II, III and IV
- •Male or female,at the age of 18 to 65 years old
- •No previous history of rectum and anus surgery
- •Consent to treatment scheme in this study and sign informed consent
排除标准
- •Under the age of 18 and Age more than 65 years.
- •Combine with other colorectal anal diseases:tumor、crohn's disease、Ulcerative colitis, intestinal tuberculosis, anal fissure, anal fistula and perianal abscess etc.
- •Combine with severe heart and brain blood vessels, liver, kidney and blood system diseases.
- •Allergic or scar constitution.
- •Pregnancy and lactation period or during menstruation.
- •Mental illness or mental retardation, unclear expression .
- •Other factors that may affect the results of the study or testers who should not enter the test according to researchers' judgment.
结局指标
主要结局
anal pain
时间窗: up to 6 months
Effective observation index will be assessed by the bloody stool.
External hemorrhoids swelling
时间窗: up to 6 months
Effective observation index will be assessed by the External hemorrhoids swelling.
postoperative uroschesis
时间窗: up to 6 months
Safety observation index will be assessed by the postoperative uroschesis.
postoperative hospital stay
时间窗: participants will be followed for the duration of hospital stay, an expected average of 1 weeks
Effective observation index will be assessed by the postoperative hospital stay.
sensation of rectal tenesmus
时间窗: up to 6 months
Effective observation index will be assessed by the sensation of rectal tenesmus.
Internal hemorrhoids prolapse
时间窗: up to 6 months
Effective observation index will be assessed by the Internal hemorrhoids prolapse.
postoperation hemorrhage
时间窗: up to 6 months
Safety observation index will be assessed by the postoperation hemorrhage.
postoperative perianal haematoma or thrombosis
时间窗: up to 6 months
Safety observation index will be assessed by the postoperative perianal haematoma or thrombosis.
Epicanthus situation
时间窗: up to 6 months
Effective observation index will be assessed by the Epicanthus situation.
rectovaginal fistula
时间窗: up to 6 months
Safety observation index will be assessed by the rectovaginal fistula.
Secondary anal fissure
时间窗: up to 6 months
Safety observation index will be assessed by the Secondary anal fissure.
fecal incontinence
时间窗: up to 6 months
Safety observation index will be assessed by the fecal incontinence.
operative time
时间窗: 1 day
Effective observation index will be assessed by the operative time.
bloody stool
时间窗: up to 6 months
Effective observation index will be assessed by the bloody stool.
anorectal stenosis
时间窗: up to 6 months
Safety observation index will be assessed by the anorectal stenosis.
次要结局
- General observation index(composite)(2 days)
研究者
YONG-HENG HE
Study Director、Professor
The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine