Clinical trial NCT02306421: A Multi Center Clinical Trial of Rph With the Simplified Milligan-Morgan Surgery on Treatment of Mixed Hemorrhoids
Official title: A Multi Center Clinical Trial of the Efficacy and Safety of Rph With the Simplified Milligan-Morgan Surgery on Treatment of Mixed Hemorrhoids
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mixed Hemorrhoids
Keywords: RPH with the simplified Milligan-Morgan surgery
mixed hemorrhoids
the effectiveness and safety
A multi center clinical trial
Lead sponsor: The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Hunan University of Traditional Chinese Medicine
name: Zhengfeng Medical Technology Company Limited of Hunan Province
First posted: 2014-12-03
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: operative time
timeFrame: 1 day
measure: postoperative hospital stay
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 1 weeks
measure: bloody stool
timeFrame: up to 6 months
measure: anal pain
timeFrame: up to 6 months
measure: sensation of rectal tenesmus
timeFrame: up to 6 months
measure: Internal hemorrhoids prolapse
timeFrame: up to 6 months
measure: External hemorrhoids swelling
timeFrame: up to 6 months
measure: Epicanthus situation
timeFrame: up to 6 months
measure: postoperation hemorrhage
timeFrame: up to 6 months
measure: postoperative uroschesis
timeFrame: up to 6 months
measure: rectovaginal fistula
timeFrame: up to 6 months
measure: Secondary anal fissure
timeFrame: up to 6 months
measure: postoperative perianal haematoma or thrombosis
timeFrame: up to 6 months
measure: fecal incontinence
timeFrame: up to 6 months
measure: anorectal stenosis
timeFrame: up to 6 months
Secondary outcomes:
measure: General observation index(composite)
timeFrame: 2 days
Other outcomes:
measure: Severe adverse events
timeFrame: up to six months
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
state: Anhui
city: Chongqing
country: China
facility: Chongqing Traditional Chinese Medicine Hospital
state: Chongqing
city: Wuhan
country: China
facility: Eighth Hospital of Wuhan City
state: Hubei
city: Changde
country: China
facility: Changde Hospital of Hunan University of Traditional Chinese Medicine
state: Hunan
city: Changsha
country: China
facility: Changsha Hospital of Hunan University of Traditional Chinese Medicine
state: Hunan
city: Changsha
country: China
facility: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
state: Hunan
city: Changsha
country: China
facility: The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine
state: Hunan
city: Chenzhou
country: China
facility: Chenzhou Hospital of Southern Medical University
state: Hunan
city: Yueyang
country: China
facility: Yueyang Hospital of Hunan University of Traditional Chinese Medicine
state: Hunan
city: Nanjing
country: China
facility: The Third Affiliated Hospital of Nanjing University of Traditional Chinese Medicine
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou Hospital of Nanjing University of Traditional Chinese Medicine
state: Jiangsu
city: Chengdu
country: China
facility: Teaching Hospital of Chengdu University of Traditional Chinese Medicine
state: Sichuan
Study officials:
affiliation: mentoring relationship
name: Hu Fan, postgraduate
role: PRINCIPAL_INVESTIGATOR
affiliation: Mentoring relationship
name: Hu Hua, postgraduate
role: PRINCIPAL_INVESTIGATOR
References: