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

Primary Purpose

Mixed Hemorrhoids

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
RPH with the simplified Milligan-Morgan
PPH with the simplified Milligan-Morgan
RPH
PPH
Milligan-Morgan
Sponsored by
The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mixed Hemorrhoids focused on measuring RPH with the simplified Milligan-Morgan surgery, mixed hemorrhoids, the effectiveness and safety, A multi center clinical trial

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
  • Chongqing Traditional Chinese Medicine Hospital
  • Eighth Hospital of Wuhan City
  • Changde Hospital of Hunan University of Traditional Chinese Medicine
  • Changsha Hospital of Hunan University of Traditional Chinese Medicine
  • The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
  • The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine
  • Chenzhou Hospital of Southern Medical University
  • Yueyang Hospital of Hunan University of Traditional Chinese Medicine
  • The Third Affiliated Hospital of Nanjing University of Traditional Chinese Medicine
  • Xuzhou Hospital of Nanjing University of Traditional Chinese Medicine
  • Teaching Hospital of Chengdu University of Traditional Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

RPH with the simplified Milligan-Morgan

PPH with the simplified Milligan-Morgan

R P H

P P H

Milligan-Morgan

Arm Description

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.

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 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.

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

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.

Outcomes

Primary Outcome Measures

operative time
Effective observation index will be assessed by the operative time.
postoperative hospital stay
Effective observation index will be assessed by the postoperative hospital stay.
bloody stool
Effective observation index will be assessed by the bloody stool.
anal pain
Effective observation index will be assessed by the bloody stool.
sensation of rectal tenesmus
Effective observation index will be assessed by the sensation of rectal tenesmus.
Internal hemorrhoids prolapse
Effective observation index will be assessed by the Internal hemorrhoids prolapse.
External hemorrhoids swelling
Effective observation index will be assessed by the External hemorrhoids swelling.
Epicanthus situation
Effective observation index will be assessed by the Epicanthus situation.
postoperation hemorrhage
Safety observation index will be assessed by the postoperation hemorrhage.
postoperative uroschesis
Safety observation index will be assessed by the postoperative uroschesis.
rectovaginal fistula
Safety observation index will be assessed by the rectovaginal fistula.
Secondary anal fissure
Safety observation index will be assessed by the Secondary anal fissure.
postoperative perianal haematoma or thrombosis
Safety observation index will be assessed by the postoperative perianal haematoma or thrombosis.
fecal incontinence
Safety observation index will be assessed by the fecal incontinence.
anorectal stenosis
Safety observation index will be assessed by the anorectal stenosis.

Secondary Outcome Measures

General observation index(composite)
General condition:sex.age.height.weight etc.and heart rate, pulse,respiration ,blood pressure etc.

Full Information

First Posted
August 24, 2014
Last Updated
December 18, 2014
Sponsor
The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Collaborators
Hunan University of Traditional Chinese Medicine, Zhengfeng Medical Technology Company Limited of Hunan Province
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1. Study Identification

Unique Protocol Identification Number
NCT02306421
Brief Title
A Multi Center Clinical Trial of Rph With the Simplified Milligan-Morgan Surgery on Treatment of Mixed Hemorrhoids
Acronym
RPHSMMH
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

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
May 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Collaborators
Hunan University of Traditional Chinese Medicine, Zhengfeng Medical Technology Company Limited of Hunan Province

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mixed Hemorrhoids
Keywords
RPH with the simplified Milligan-Morgan surgery, mixed hemorrhoids, the effectiveness and safety, A multi center clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
3000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RPH with the simplified Milligan-Morgan
Arm Type
Active Comparator
Arm Description
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.
Arm Title
PPH with the simplified Milligan-Morgan
Arm Type
Active Comparator
Arm Description
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.
Arm Title
R P H
Arm Type
Active Comparator
Arm Description
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.
Arm Title
P P H
Arm Type
Active Comparator
Arm Description
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
Arm Title
Milligan-Morgan
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
RPH with the simplified Milligan-Morgan
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
PPH with the simplified Milligan-Morgan
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
RPH
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
PPH
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Milligan-Morgan
Intervention Description
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.
Primary Outcome Measure Information:
Title
operative time
Description
Effective observation index will be assessed by the operative time.
Time Frame
1 day
Title
postoperative hospital stay
Description
Effective observation index will be assessed by the postoperative hospital stay.
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 1 weeks
Title
bloody stool
Description
Effective observation index will be assessed by the bloody stool.
Time Frame
up to 6 months
Title
anal pain
Description
Effective observation index will be assessed by the bloody stool.
Time Frame
up to 6 months
Title
sensation of rectal tenesmus
Description
Effective observation index will be assessed by the sensation of rectal tenesmus.
Time Frame
up to 6 months
Title
Internal hemorrhoids prolapse
Description
Effective observation index will be assessed by the Internal hemorrhoids prolapse.
Time Frame
up to 6 months
Title
External hemorrhoids swelling
Description
Effective observation index will be assessed by the External hemorrhoids swelling.
Time Frame
up to 6 months
Title
Epicanthus situation
Description
Effective observation index will be assessed by the Epicanthus situation.
Time Frame
up to 6 months
Title
postoperation hemorrhage
Description
Safety observation index will be assessed by the postoperation hemorrhage.
Time Frame
up to 6 months
Title
postoperative uroschesis
Description
Safety observation index will be assessed by the postoperative uroschesis.
Time Frame
up to 6 months
Title
rectovaginal fistula
Description
Safety observation index will be assessed by the rectovaginal fistula.
Time Frame
up to 6 months
Title
Secondary anal fissure
Description
Safety observation index will be assessed by the Secondary anal fissure.
Time Frame
up to 6 months
Title
postoperative perianal haematoma or thrombosis
Description
Safety observation index will be assessed by the postoperative perianal haematoma or thrombosis.
Time Frame
up to 6 months
Title
fecal incontinence
Description
Safety observation index will be assessed by the fecal incontinence.
Time Frame
up to 6 months
Title
anorectal stenosis
Description
Safety observation index will be assessed by the anorectal stenosis.
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
General observation index(composite)
Description
General condition:sex.age.height.weight etc.and heart rate, pulse,respiration ,blood pressure etc.
Time Frame
2 days
Other Pre-specified Outcome Measures:
Title
Severe adverse events
Time Frame
up to six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hu Fan, postgraduate
Organizational Affiliation
mentoring relationship
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hu Hua, postgraduate
Organizational Affiliation
Mentoring relationship
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230031
Country
China
Facility Name
Chongqing Traditional Chinese Medicine Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400021
Country
China
Facility Name
Eighth Hospital of Wuhan City
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430010
Country
China
Facility Name
Changde Hospital of Hunan University of Traditional Chinese Medicine
City
Changde
State/Province
Hunan
ZIP/Postal Code
415000
Country
China
Facility Name
Changsha Hospital of Hunan University of Traditional Chinese Medicine
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Facility Name
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Facility Name
The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410005
Country
China
Facility Name
Chenzhou Hospital of Southern Medical University
City
Chenzhou
State/Province
Hunan
ZIP/Postal Code
423000
Country
China
Facility Name
Yueyang Hospital of Hunan University of Traditional Chinese Medicine
City
Yueyang
State/Province
Hunan
ZIP/Postal Code
414000
Country
China
Facility Name
The Third Affiliated Hospital of Nanjing University of Traditional Chinese Medicine
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210001
Country
China
Facility Name
Xuzhou Hospital of Nanjing University of Traditional Chinese Medicine
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221009
Country
China
Facility Name
Teaching Hospital of Chengdu University of Traditional Chinese Medicine
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610072
Country
China

12. IPD Sharing Statement

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

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