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

Mixed Hemorrhoids Clinical Trial

— 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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02306421
• Other study ID #: SecondUTCM
• Status: Enrolling by invitation
• Phase: N/A
• First received: August 24, 2014
• Last updated: December 18, 2014
• Start date: August 2014
• Est. completion date: May 2015

Study information

• Verified date: November 2014
• Source: The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 3000
• Est. completion date: May 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhoids
• Mixed Hemorrhoids

Intervention

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.
• 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.

Locations

Country	Name	City	State
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	Teaching Hospital of Chengdu University of Traditional Chinese Medicine	Chengdu	Sichuan
China	Chenzhou Hospital of Southern Medical University	Chenzhou	Hunan
China	Chongqing Traditional Chinese Medicine Hospital	Chongqing	Chongqing
China	The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine	Hefei	Anhui
China	The Third Affiliated Hospital of Nanjing University of Traditional Chinese Medicine	Nanjing	Jiangsu
China	Eighth Hospital of Wuhan City	Wuhan	Hubei
China	Xuzhou Hospital of Nanjing University of Traditional Chinese Medicine	Xuzhou	Jiangsu
China	Yueyang Hospital of Hunan University of Traditional Chinese Medicine	Yueyang	Hunan

Sponsors (3)

Lead Sponsor	Collaborator
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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Severe adverse events		up to six months	Yes
Primary	operative time	Effective observation index will be assessed by the operative time.	1 day	No
Primary	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	No
Primary	bloody stool	Effective observation index will be assessed by the bloody stool.	up to 6 months	No
Primary	anal pain	Effective observation index will be assessed by the bloody stool.	up to 6 months	No
Primary	sensation of rectal tenesmus	Effective observation index will be assessed by the sensation of rectal tenesmus.	up to 6 months	No
Primary	Internal hemorrhoids prolapse	Effective observation index will be assessed by the Internal hemorrhoids prolapse.	up to 6 months	No
Primary	External hemorrhoids swelling	Effective observation index will be assessed by the External hemorrhoids swelling.	up to 6 months	No
Primary	Epicanthus situation	Effective observation index will be assessed by the Epicanthus situation.	up to 6 months	No
Primary	postoperation hemorrhage	Safety observation index will be assessed by the postoperation hemorrhage.	up to 6 months	Yes
Primary	postoperative uroschesis	Safety observation index will be assessed by the postoperative uroschesis.	up to 6 months	Yes
Primary	rectovaginal fistula	Safety observation index will be assessed by the rectovaginal fistula.	up to 6 months	Yes
Primary	Secondary anal fissure	Safety observation index will be assessed by the Secondary anal fissure.	up to 6 months	Yes
Primary	postoperative perianal haematoma or thrombosis	Safety observation index will be assessed by the postoperative perianal haematoma or thrombosis.	up to 6 months	Yes
Primary	fecal incontinence	Safety observation index will be assessed by the fecal incontinence.	up to 6 months	Yes
Primary	anorectal stenosis	Safety observation index will be assessed by the anorectal stenosis.	up to 6 months	Yes
Secondary	General observation index(composite)	General condition:sex.age.height.weight etc.and heart rate, pulse,respiration ,blood pressure etc.	2 days	No