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