UnknownNot Applicable

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

China3,000 participantsStarted 2014-08

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

operative time

Timeframe: 1 day

postoperative hospital stay

Timeframe: participants will be followed for the duration of hospital stay, an expected average of 1 weeks

bloody stool

Timeframe: up to 6 months

anal pain

Timeframe: up to 6 months

sensation of rectal tenesmus

Timeframe: up to 6 months

Internal hemorrhoids prolapse

Timeframe: up to 6 months

External hemorrhoids swelling

Timeframe: up to 6 months

Epicanthus situation

Timeframe: up to 6 months

Trial details

NCT IDNCT02306421

SponsorThe Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-03

View on ClinicalTrials.gov More Mixed Hemorrhoids trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

operative time

Timeframe: 1 day

postoperative hospital stay

Timeframe: participants will be followed for the duration of hospital stay, an expected average of 1 weeks

bloody stool

Timeframe: up to 6 months

anal pain

Timeframe: up to 6 months

sensation of rectal tenesmus

Timeframe: up to 6 months

Internal hemorrhoids prolapse

Timeframe: up to 6 months

External hemorrhoids swelling

Timeframe: up to 6 months

Epicanthus situation

Timeframe: up to 6 months