NCT02306421

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

12 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

December 23, 2014

Status Verified

November 1, 2014

Enrollment Period

7 months

First QC Date

August 24, 2014

Last Update Submit

December 18, 2014

Conditions

Mixed Hemorrhoids

Keywords

RPH with the simplified Milligan-Morgan surgerymixed hemorrhoidsthe effectiveness and safetyA multi center clinical trial

Outcome Measures

Primary Outcomes (15)

  • operative time

    Effective observation index will be assessed by the operative time.

    1 day

  • 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

  • bloody stool

    Effective observation index will be assessed by the bloody stool.

    up to 6 months

  • anal pain

    Effective observation index will be assessed by the bloody stool.

    up to 6 months

  • sensation of rectal tenesmus

    Effective observation index will be assessed by the sensation of rectal tenesmus.

    up to 6 months

  • Internal hemorrhoids prolapse

    Effective observation index will be assessed by the Internal hemorrhoids prolapse.

    up to 6 months

  • External hemorrhoids swelling

    Effective observation index will be assessed by the External hemorrhoids swelling.

    up to 6 months

  • Epicanthus situation

    Effective observation index will be assessed by the Epicanthus situation.

    up to 6 months

  • postoperation hemorrhage

    Safety observation index will be assessed by the postoperation hemorrhage.

    up to 6 months

  • postoperative uroschesis

    Safety observation index will be assessed by the postoperative uroschesis.

    up to 6 months

  • rectovaginal fistula

    Safety observation index will be assessed by the rectovaginal fistula.

    up to 6 months

  • Secondary anal fissure

    Safety observation index will be assessed by the Secondary anal fissure.

    up to 6 months

  • postoperative perianal haematoma or thrombosis

    Safety observation index will be assessed by the postoperative perianal haematoma or thrombosis.

    up to 6 months

  • fecal incontinence

    Safety observation index will be assessed by the fecal incontinence.

    up to 6 months

  • anorectal stenosis

    Safety observation index will be assessed by the anorectal stenosis.

    up to 6 months

Secondary Outcomes (1)

  • General observation index(composite)

    2 days

Other Outcomes (1)

  • Severe adverse events

    up to six months

Study Arms (5)

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.

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.

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.

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

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.

Procedure: Milligan-Morgan

Interventions

RPH with the simplified Milligan-MorganPROCEDURE

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
PPH with the simplified Milligan-MorganPROCEDURE

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
RPHPROCEDURE

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.

R P H
PPHPROCEDURE

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

P P H
Milligan-MorganPROCEDURE

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Hefei, Anhui, 230031, China

Location

Chongqing Traditional Chinese Medicine Hospital

Chongqing, Chongqing Municipality, 400021, China

Location

Eighth Hospital of Wuhan City

Wuhan, Hubei, 430010, China

Location

Changde Hospital of Hunan University of Traditional Chinese Medicine

Changde, Hunan, 415000, China

Location

Changsha Hospital of Hunan University of Traditional Chinese Medicine

Changsha, Hunan, 410000, China

Location

The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

Changsha, Hunan, 410000, China

Location

The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine

Changsha, Hunan, 410005, China

Location

Chenzhou Hospital of Southern Medical University

Chenzhou, Hunan, 423000, China

Location

Yueyang Hospital of Hunan University of Traditional Chinese Medicine

Yueyang, Hunan, 414000, China

Location

The Third Affiliated Hospital of Nanjing University of Traditional Chinese Medicine

Nanjing, Jiangsu, 210001, China

Location

Xuzhou Hospital of Nanjing University of Traditional Chinese Medicine

Xuzhou, Jiangsu, 221009, China

Location

Teaching Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, 610072, China

Location

Study Officials

  • Hu Fan, postgraduate

    mentoring relationship

    PRINCIPAL INVESTIGATOR

  • Hu Hua, postgraduate

    Mentoring relationship

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Director、Professor

Study Record Dates

First Submitted

August 24, 2014

First Posted

December 3, 2014

Study Start

August 1, 2014

Primary Completion

March 1, 2015

Study Completion

May 1, 2015

Last Updated

December 23, 2014

Record last verified: 2014-11

Locations

CN(12)