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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2014 by YONG‑HENG HE, The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine.
Recruitment status was:  Enrolling by invitation
Sponsor:
Collaborators:
Hunan University of Traditional Chinese Medicine
Zhengfeng Medical Technology Company Limited of Hunan Province
Information provided by (Responsible Party):
YONG‑HENG HE, The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT02306421
First received: August 24, 2014
Last updated: December 18, 2014
Last verified: November 2014
  Purpose
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.

Condition Intervention
Mixed Hemorrhoids Procedure: RPH with the simplified Milligan-Morgan Procedure: PPH with the simplified Milligan-Morgan Procedure: RPH Procedure: PPH Procedure: Milligan-Morgan

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by YONG‑HENG HE, The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • operative time [ Time Frame: 1 day ]
    Effective observation index will be assessed by the operative time.

  • postoperative hospital stay [ Time Frame: 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.

  • bloody stool [ Time Frame: up to 6 months ]
    Effective observation index will be assessed by the bloody stool.

  • anal pain [ Time Frame: up to 6 months ]
    Effective observation index will be assessed by the bloody stool.

  • sensation of rectal tenesmus [ Time Frame: up to 6 months ]
    Effective observation index will be assessed by the sensation of rectal tenesmus.

  • Internal hemorrhoids prolapse [ Time Frame: up to 6 months ]
    Effective observation index will be assessed by the Internal hemorrhoids prolapse.

  • External hemorrhoids swelling [ Time Frame: up to 6 months ]
    Effective observation index will be assessed by the External hemorrhoids swelling.

  • Epicanthus situation [ Time Frame: up to 6 months ]
    Effective observation index will be assessed by the Epicanthus situation.

  • postoperation hemorrhage [ Time Frame: up to 6 months ]
    Safety observation index will be assessed by the postoperation hemorrhage.

  • postoperative uroschesis [ Time Frame: up to 6 months ]
    Safety observation index will be assessed by the postoperative uroschesis.

  • rectovaginal fistula [ Time Frame: up to 6 months ]
    Safety observation index will be assessed by the rectovaginal fistula.

  • Secondary anal fissure [ Time Frame: up to 6 months ]
    Safety observation index will be assessed by the Secondary anal fissure.

  • postoperative perianal haematoma or thrombosis [ Time Frame: up to 6 months ]
    Safety observation index will be assessed by the postoperative perianal haematoma or thrombosis.

  • fecal incontinence [ Time Frame: up to 6 months ]
    Safety observation index will be assessed by the fecal incontinence.

  • anorectal stenosis [ Time Frame: up to 6 months ]
    Safety observation index will be assessed by the anorectal stenosis.


Secondary Outcome Measures:
  • General observation index(composite) [ Time Frame: 2 days ]
    General condition:sex.age.height.weight etc.and heart rate, pulse,respiration ,blood pressure etc.


Other Outcome Measures:
  • Severe adverse events [ Time Frame: up to six months ]

Enrollment: 3000
Study Start Date: August 2014
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Procedure: 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.
Active Comparator: 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.
Procedure: 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.
Active Comparator: 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.
Procedure: 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.
Active Comparator: 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
Procedure: 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
Active Comparator: 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.
Procedure: 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.

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

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02306421

Locations
China, Anhui
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Hefei, Anhui, China, 230031
China, Chongqing
Chongqing Traditional Chinese Medicine Hospital
Chongqing, Chongqing, China, 400021
China, Hubei
Eighth Hospital of Wuhan City
Wuhan, Hubei, China, 430010
China, Hunan
Changde Hospital of Hunan University of Traditional Chinese Medicine
Changde, Hunan, China, 415000
Changsha Hospital of Hunan University of Traditional Chinese Medicine
Changsha, Hunan, China, 410000
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Changsha, Hunan, China, 410000
The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Changsha, Hunan, China, 410005
Chenzhou Hospital of Southern Medical University
Chenzhou, Hunan, China, 423000
Yueyang Hospital of Hunan University of Traditional Chinese Medicine
Yueyang, Hunan, China, 414000
China, Jiangsu
The Third Affiliated Hospital of Nanjing University of Traditional Chinese Medicine
Nanjing, Jiangsu, China, 210001
Xuzhou Hospital of Nanjing University of Traditional Chinese Medicine
Xuzhou, Jiangsu, China, 221009
China, Sichuan
Teaching Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, China, 610072
Sponsors and Collaborators
The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Hunan University of Traditional Chinese Medicine
Zhengfeng Medical Technology Company Limited of Hunan Province
Investigators
Principal Investigator: Hu Fan, postgraduate mentoring relationship
Principal Investigator: Hu Hua, postgraduate Mentoring relationship
  More Information

Responsible Party: YONG‑HENG HE, Study Director、Professor, The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02306421     History of Changes
Other Study ID Numbers: SecondUTCM
Study First Received: August 24, 2014
Last Updated: December 18, 2014

Keywords provided by YONG‑HENG HE, The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine:
RPH with the simplified Milligan-Morgan surgery
mixed hemorrhoids
the effectiveness and safety
A multi center clinical trial

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Polystyrene sulfonic acid
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 22, 2017