TSTstarr + for Treatment of Severe Prolapsed Hemorrhoids --- a Multi-center Randomized Controlled Clinical Trail

Study Overview
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Brief Summary
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TSTstarr+ in the treatment of severe hemorrhoids prolapse--A multi center randomized controlled clinical trial.The aim of this stuy is to compare the first year hemorrhoids recurrence rate of TSTstarr+ and PPH in the treatment of severe hemorrhoids.

Conditions
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Hemorrhoids

Intervention / Treatment
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* Procedure: TSTstarr+
* Procedure: PPH


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: severe prolapsed hemorrhoids no significant anal-malformation before operation having signed the informed consent. Exclusion Criteria: needing emergency operation or having previous history of hemorrhoids operation with other anal diseases at the same time such as : anal fissure, anal fistula and perianal abscess and so on diagnosed with inflammatory bowel disease or proctitis diagnosed with colorectal cancer associated with cardiovascular and cerebrovascular diseases and other diseases so that can not tolerate surgery or increase the risk of surgery with chronic or acute renal insufficiency patients coagulation abnormalities or with anticoagulation treatment at present diagnosed with diabetes with poor glycemic control in women with pregnant or menstruation The intellectual disabilities or mental disorder had participated in other clinical trial before we selected 4 weeks other severe complications.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A( TSTstarr+ group)<br>TSTstarr+ is a kind of modified STARR（stapled transanal rectal resection ） operation, compared to the traditional STARR operation, it does not need two staplers but with a larger diameter stapler,  + means better . Patients in group A with severe prolapsed hemorrhoids will undergo TSTstarr+ operation . | Procedure: TSTstarr+<br>* TSTstarr+ : a kind of modified STARR（stapled transanal rectal resection ） operation, compared to the traditional STARR operation, it does not need two staplers but with a larger diameter stapler,  + means better . Patients in group A with severe prolapsed hemorrhoids will undergo TSTstarr+ operation .<br>|
| Active Comparator: group B ( PPH group)<br>PPH is short fo procedure for prolapsed hemorrhoids .Patients in group B with severe prolapsed hemorrhoids will undergo PPH operation. | Procedure: PPH<br>* PPH is short fo procedure for prolapsed hemorrhoids .Patients in group B with severe prolapsed hemorrhoids will undergo PPH operation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the recurrence rate of the severe prolapsed Hemorrhoids after surgery | 780 patients will be enrolled in one year.All patients will be followed up for one year, and then calculate 1 year recurrence rate between TSTstarr+ group and PPH group | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time |  | 1 year | 
| Intraoperative hemorrhage |  | 1 year | 
| The weight of specimens |  | 1year | 
| The volume of specimens |  | 1year | 
| The number of patients with anal pain after surgery |  | 2 years | 
| The number of patients with fecal urgency after surgery |  | 2 years | 
| The number of patients with stricture of anus after surgery |  | 2 years | 
| The number of patients with hemorrhage after surgery |  | 2 years | 
| The number of patients with retention of urine in the early time after surgery |  | 2 years | 
| The number of patients with edema of the anal margin in the early time after surgery |  | 2 years | 
| The time of returning to normal |  | 2 years | 
| The total cost of hospitalization |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemorrhoids, The recurrence rate, PPH, TSTstarr+