A Multi Center Clinical Trial of Rph With the Simplified Milligan-Morgan Surgery on Treatment of Mixed Hemorrhoids

Study Overview
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Brief Summary
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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
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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 toTCM 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.

Official Title
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A Multi Center Clinical Trial of the Efficacy and Safety of Rph With the Simplified Milligan-Morgan Surgery on Treatment of Mixed Hemorrhoids

Conditions
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Mixed Hemorrhoids

Intervention / Treatment
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* Procedure: RPH with the simplified Milligan-Morgan
* Procedure: PPH with the simplified Milligan-Morgan
* Procedure: RPH
* Procedure: PPH
* Procedure: Milligan-Morgan


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RPH with the simplified Milligan-Morgan<br>RPH is a new therapy for hemorrhoid following the improvement of rubber band ligation. The treatment principle is: shrinkage of mucous membrane after the ligation, lift of anal cushion, the local inflammatory response resulting in adhesion of mucosa and submucosa and shallow muscle layer, anal cushion fixing to a higher position, at the same time by using the elastic contraction of automatic elastic line partly blocking blood supply of Internal hemorrhoids or reducing venous stasis, decreasing congestion hypertrophy of hemorrhoids. 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 in 1971.The operation method is simple, the operation time is shortened. | Procedure: RPH with the simplified Milligan-Morgan<br>* RPH is a new therapy for hemorrhoid following the improvement of rubber band ligation. The treatment principle is: shrinkage of mucous membrane after the ligation, lift of anal cushion, the local inflammatory response resulting in adhesion of mucosa and submucosa and shallow muscle layer, anal cushion fixing to a higher position, at the same time by using the elastic contraction of automatic elastic line partly blocking blood supply of Internal hemorrhoids or reducing venous stasis, decreasing congestion hypertrophy of hemorrhoids. 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 in 1971.The operation method is simple, the operation time is shortened.<br>|
| Active Comparator: PPH with the simplified Milligan-Morgan<br>According to anal cushion down theory of the formation of hemorrhoids, the Italy scholar Longo pioneered a new method for the treatment of circular prolapsed internal hemorrhoids In 1998.Its principle is resection of lower rectal mucosa and submucosa of the intestinal wall tissue in the ring above the hemorrhoids through surgical staples,anastomosis of the proximal and distal mucosa , lifting and fixing down anal cushion, recovering to the normal anatomical position.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 in 1971.The operation method is simple, the operation time is shortened. | Procedure: PPH with the simplified Milligan-Morgan<br>* According to anal cushion down theory of the formation of hemorrhoids, the Italy scholar Longo pioneered a new method for the treatment of circular prolapsed internal hemorrhoids In 1998.Its principle is resection of lower rectal mucosa and submucosa of the intestinal wall tissue in the ring above the hemorrhoids through surgical staples,anastomosis of the proximal and distal mucosa , lifting and fixing down anal cushion, recovering to the normal anatomical position.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 in 1971.The operation method is simple, the operation time is shortened.<br>|
| Active Comparator: R P H<br>RPH is a new therapy for hemorrhoid following the improvement of rubber band ligation.The treatment principle is: shrinkage of mucous membrane after the ligation, lift of anal cushion, the local inflammatory response resulting in adhesion of mucosa and submucosa and shallow muscle layer , anal cushion fixing to a higher position, at the same time by using the elastic contraction of automatic elastic line partly blocking blood supply of Internal hemorrhoids or reducing venous stasis, decreasing congestion hypertrophy of hemorrhoids , making hemorrhoidal lump shrink, thus eliminating bleeding and prolapse symptoms of hemorrhoid.It is suitable for internal hemorrhoids in every period and internal hemorrhoids part of mixed hemorrhoid. | Procedure: RPH<br>* RPH is a new therapy for hemorrhoid following the improvement of rubber band ligation.The treatment principle is: shrinkage of mucous membrane after the ligation, lift of anal cushion, the local inflammatory response resulting in adhesion of mucosa and submucosa and shallow muscle layer , anal cushion fixing to a higher position, at the same time by using the elastic contraction of automatic elastic line partly blocking blood supply of Internal hemorrhoids or reducing venous stasis, decreasing congestion hypertrophy of hemorrhoids , making hemorrhoidal lump shrink, thus eliminating bleeding and prolapse symptoms of hemorrhoid.It is suitable for internal hemorrhoids in every period and internal hemorrhoids part of mixed hemorrhoid.<br>|
| Active Comparator: P P H<br>According to anal cushion down theory of the formation of hemorrhoids, the Italy scholar Longo pioneered a new method for the treatment of circular prolapsed internal hemorrhoids-PPH.In 1998.Its principle is resection of lower rectal mucosa and submucosa of the intestinal wall tissue in the ring above the hemorrhoids through surgical staples,anastomosis of the proximal and distal mucosa , lifting and fixing down anal cushion, recovering to the normal anatomical position | Procedure: PPH<br>* According to anal cushion down theory of the formation of hemorrhoids, the Italy scholar Longo pioneered a new method for the treatment of circular prolapsed internal hemorrhoids In 1998.Its principle is resection of lower rectal mucosa and submucosa of the intestinal wall tissue in the ring above the hemorrhoids through surgical staples,anastomosis of the proximal and distal mucosa , lifting and fixing down anal cushion, recovering to the normal anatomical position<br>|
| Active Comparator: Milligan-Morgan<br>Milligan-Morgan surgery ,created in 1937 by Milligan etc,whose essence is to excise hemorrhoids of increasing prolapse in anatomy has good curative effect, low recurrence.It is currently the most common clinical surgery. | Procedure: Milligan-Morgan<br>* Milligan-Morgan surgery ,created in 1937 by Milligan etc,whose essence is to excise hemorrhoids of increasing prolapse in anatomy has good curative effect, low recurrence.It is currently the most common clinical surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative time | Effective observation index will be assessed by the operative time. | 1 day | 
| postoperative hospital stay | Effective observation index will be assessed by the postoperative hospital stay. | participants will be followed for the duration of hospital stay, an expected average of 1 weeks | 
| bloody stool | Effective observation index will be assessed by the bloody stool. | up to 6 months | 
| anal pain | Effective observation index will be assessed by the bloody stool. | up to 6 months | 
| sensation of rectal tenesmus | Effective observation index will be assessed by the sensation of rectal tenesmus. | up to 6 months | 
| Internal hemorrhoids prolapse | Effective observation index will be assessed by the Internal hemorrhoids prolapse. | up to 6 months | 
| External hemorrhoids swelling | Effective observation index will be assessed by the External hemorrhoids swelling. | up to 6 months | 
| Epicanthus situation | Effective observation index will be assessed by the Epicanthus situation. | up to 6 months | 
| postoperation hemorrhage | Safety observation index will be assessed by the postoperation hemorrhage. | up to 6 months | 
| postoperative uroschesis | Safety observation index will be assessed by the postoperative uroschesis. | up to 6 months | 
| rectovaginal fistula | Safety observation index will be assessed by the rectovaginal fistula. | up to 6 months | 
| Secondary anal fissure | Safety observation index will be assessed by the Secondary anal fissure. | up to 6 months | 
| postoperative perianal haematoma or thrombosis | Safety observation index will be assessed by the postoperative perianal haematoma or thrombosis. | up to 6 months | 
| fecal incontinence | Safety observation index will be assessed by the fecal incontinence. | up to 6 months | 
| anorectal stenosis | Safety observation index will be assessed by the anorectal stenosis. | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General observation index(composite) | General condition:sex.age.height.weight etc.and heart rate, pulse,respiration ,blood pressure etc. | 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RPH with the simplified Milligan-Morgan surgery, mixed hemorrhoids, the effectiveness and safety, A multi center clinical trial