A Multi Center Clinical Trial of Rph With the Simplified Milligan-Morgan Surgery on Treatment of Mixed Hemorrhoids
NCT ID: NCT02306421
Last Updated: 2014-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
3000 participants
INTERVENTIONAL
2014-08-31
2015-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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RPH with the simplified Milligan-Morgan
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.
RPH with the simplified Milligan-Morgan
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.
PPH with the simplified Milligan-Morgan
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.
PPH with the simplified Milligan-Morgan
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.
R P H
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.
RPH
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.
P P H
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
PPH
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
Milligan-Morgan
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.
Milligan-Morgan
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.
Interventions
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RPH with the simplified Milligan-Morgan
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.
PPH with the simplified Milligan-Morgan
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.
RPH
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.
PPH
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
Milligan-Morgan
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Hunan University of Traditional Chinese Medicine
OTHER
Zhengfeng Medical Technology Company Limited of Hunan Province
INDUSTRY
The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine
OTHER
Responsible Party
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YONG-HENG HE
Study Director、Professor
Principal Investigators
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Hu Fan, postgraduate
Role: PRINCIPAL_INVESTIGATOR
mentoring relationship
Hu Hua, postgraduate
Role: PRINCIPAL_INVESTIGATOR
Mentoring relationship
Locations
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The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Hefei, Anhui, China
Chongqing Traditional Chinese Medicine Hospital
Chongqing, Chongqing Municipality, China
Eighth Hospital of Wuhan City
Wuhan, Hubei, China
Changde Hospital of Hunan University of Traditional Chinese Medicine
Changde, Hunan, China
Changsha Hospital of Hunan University of Traditional Chinese Medicine
Changsha, Hunan, China
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Changsha, Hunan, China
The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Changsha, Hunan, China
Chenzhou Hospital of Southern Medical University
Chenzhou, Hunan, China
Yueyang Hospital of Hunan University of Traditional Chinese Medicine
Yueyang, Hunan, China
The Third Affiliated Hospital of Nanjing University of Traditional Chinese Medicine
Nanjing, Jiangsu, China
Xuzhou Hospital of Nanjing University of Traditional Chinese Medicine
Xuzhou, Jiangsu, China
Teaching Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, China
Countries
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Other Identifiers
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SecondUTCM
Identifier Type: -
Identifier Source: org_study_id