Mixed HemorrhoidsRPHSMMHNCT02306421
A Multi Center Clinical Trial of Rph With the Simplified Milligan-Morgan Surgery on Treatment of Mixed Hemorrhoids
A study testing RPH with the simplified Milligan-Morgan, PPH with the simplified Milligan-Morgan and RPH in people with Mixed Hemorrhoids, run by The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine at 12 sites in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mixed Hemorrhoids
- What is being tested?
- RPH with the simplified Milligan-Morgan, PPH with the simplified Milligan-Morgan and RPH
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 12 sitesChina
- Study dates
- Aug 2014to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Changde Hospital of Hunan University of Traditional Chinese Medicine
Changde, Hunan, 415000
Changsha Hospital of Hunan University of Traditional Chinese Medicine
Changsha, Hunan, 410000
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Changsha, Hunan, 410000
The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Changsha, Hunan, 410005
Teaching Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, 610072
Chenzhou Hospital of Southern Medical University
Chenzhou, Hunan, 423000
Chongqing Traditional Chinese Medicine Hospital
Chongqing, Chongqing Municipality, 400021
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Hefei, Anhui, 230031
The Third Affiliated Hospital of Nanjing University of Traditional Chinese Medicine
Nanjing, Jiangsu, 210001
Eighth Hospital of Wuhan City
Wuhan, Hubei, 430010
Xuzhou Hospital of Nanjing University of Traditional Chinese Medicine
Xuzhou, Jiangsu, 221009
Yueyang Hospital of Hunan University of Traditional Chinese Medicine
Yueyang, Hunan, 414000
About this study
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
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.
Read the 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.
- Conditions
- Mixed Hemorrhoids
- Being tested
- RPH with the simplified Milligan-Morgan, PPH with the simplified Milligan-Morgan, RPH, PPH, Milligan-Morgan
- Keywords
- RPH with the simplified Milligan-Morgan surgery, mixed hemorrhoids, the effectiveness and safety, A multi center clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RPH with the simplified Milligan-MorganProcedure or surgery
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-MorganProcedure or surgery
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.
RPHProcedure or surgery
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.
PPHProcedure or surgery
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-MorganProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| RPH with the simplified Milligan-Morgan | Active comparator | 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. Receives: Procedure: RPH with the simplified Milligan-Morgan |
| PPH with the simplified Milligan-Morgan | Active comparator | 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. Receives: Procedure: PPH with the simplified Milligan-Morgan |
| R P H | Active comparator | 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. Receives: Procedure: RPH |
| P P H | Active comparator | 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 Receives: Procedure: PPH |
| Milligan-Morgan | Active comparator | 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. Receives: Procedure: Milligan-Morgan |
What is being measured
The primary outcome is the main question the study is designed to answer.
operative time
Effective observation index will be assessed by the operative time.
Measured: 1 day
postoperative hospital stay
Effective observation index will be assessed by the postoperative hospital stay.
Measured: 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.
Measured: up to 6 months
anal pain
Effective observation index will be assessed by the bloody stool.
Measured: up to 6 months
sensation of rectal tenesmus
Effective observation index will be assessed by the sensation of rectal tenesmus.
Measured: up to 6 months
Internal hemorrhoids prolapse
Effective observation index will be assessed by the Internal hemorrhoids prolapse.
Measured: up to 6 months
External hemorrhoids swelling
Effective observation index will be assessed by the External hemorrhoids swelling.
Measured: up to 6 months
Epicanthus situation
Effective observation index will be assessed by the Epicanthus situation.
Measured: up to 6 months
postoperation hemorrhage
Safety observation index will be assessed by the postoperation hemorrhage.
Measured: up to 6 months
postoperative uroschesis
Safety observation index will be assessed by the postoperative uroschesis.
Measured: up to 6 months
rectovaginal fistula
Safety observation index will be assessed by the rectovaginal fistula.
Measured: up to 6 months
Secondary anal fissure
Safety observation index will be assessed by the Secondary anal fissure.
Measured: up to 6 months
postoperative perianal haematoma or thrombosis
Safety observation index will be assessed by the postoperative perianal haematoma or thrombosis.
Measured: up to 6 months
fecal incontinence
Safety observation index will be assessed by the fecal incontinence.
Measured: up to 6 months
anorectal stenosis
Safety observation index will be assessed by the anorectal stenosis.
Measured: up to 6 months
Secondary outcomes (1)
General observation index(composite)
General condition:sex.age.height.weight etc.and heart rate, pulse,respiration ,blood pressure etc.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startAug 2014
- Primary completionMar 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mixed HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Hunan University of Traditional Chinese Medicine, Zhengfeng Medical Technology Company Limited of Hunan Province
- Responsible party
- Principal investigator, YONG-HENG HE, The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine
- Investigators
- Hu Fan, postgraduate, Principal investigator, mentoring relationshipHu Hua, postgraduate, Principal investigator, Mentoring relationship
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306421
- Sponsor's protocol ID
- SecondUTCM
- Acronym
- RPHSMMH
- Status last verified
- Nov 2014
- First submitted
- 24 Aug 2014
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02306421
- Acronym / sponsor ID
- RPHSMMH / SecondUTCM
- Conditions
- Mixed Hemorrhoids
- Keywords
- RPH with the simplified Milligan-Morgan surgery, mixed hemorrhoids, the effectiveness and safety, A multi center clinical trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- The Second Affiliated Hospital of Hunan University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Hunan University of Traditional Chinese Medicine, Zhengfeng Medical Technology Company Limited of Hunan Province
- Study start
- Aug 2014
- Primary completion
- Mar 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 3 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| RPH with the simplified Milligan-Morgan | Active comparator | Procedure: RPH with the simplified Milligan-MorganRPH 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 | Active comparator | Procedure: PPH with the simplified Milligan-MorganAccording 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 | Active comparator | Procedure: RPHRPH 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 | Active comparator | Procedure: PPHAccording 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 | Active comparator | Procedure: Milligan-MorganMilligan-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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RPH with the simplified Milligan-MorganRPH 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 or surgery | RPH with the simplified Milligan-Morgan |
| PPH with the simplified Milligan-MorganAccording 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 or surgery | PPH with the simplified Milligan-Morgan |
| RPHRPH 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 or surgery | R P H |
| PPHAccording 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 | Procedure or surgery | P P H |
| Milligan-MorganMilligan-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 or surgery | Milligan-Morgan |
Primary outcome
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.
1 secondary outcome
General observation index(composite)
Time frame: 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hu Fan, postgraduate principal investigator
mentoring relationship
Hu Hua, postgraduate principal investigator
Mentoring relationship
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RPH with the simplified Milligan-Morgan, PPH with the simplified Milligan-Morgan and RPH in people with Mixed Hemorrhoids, run by The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine at 12 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
operative time (time frame: 1 day). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2014.