TSTstarr + for Treatment of Severe Prolapsed Hemorrhoids --- a Multi-center Randomized Controlled Clinical Trail
NCT ID: NCT02295592
Last Updated: 2014-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
780 participants
INTERVENTIONAL
2014-11-30
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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group A( TSTstarr+ group)
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 .
TSTstarr+
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 .
group B ( PPH group)
PPH is short fo procedure for prolapsed hemorrhoids .Patients in group B with severe prolapsed hemorrhoids will undergo PPH operation.
PPH
PPH is short fo procedure for prolapsed hemorrhoids .Patients in group B with severe prolapsed hemorrhoids will undergo PPH operation.
Interventions
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TSTstarr+
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 .
PPH
PPH is short fo procedure for prolapsed hemorrhoids .Patients in group B with severe prolapsed hemorrhoids will undergo PPH operation.
Eligibility Criteria
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Inclusion Criteria
* no significant anal-malformation before operation
* having signed the informed consent.
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Suzhou Touchstone International Medical Science Co.,Ltd.
UNKNOWN
Chengdu Anorectal Hospital
UNKNOWN
Wuhan University
OTHER
Fujian Provincial Hospital
OTHER
First Affiliated Hospital of Fujian Medical University
OTHER
Nanhai Hospital of Traditional Chinese Medicine
OTHER
Changshu Hospital of Traditional Chinese Medicine
OTHER
Xuzhou Central Hospital
OTHER
First Affiliated Hospital of Xinjiang Medical University
OTHER
Shenyang Anorectal Hospital
OTHER
Wulumuqi General Hospital of Lanzhou Military Command
OTHER
The First Affiliated Hospital of Guangxi traditional Chinese Medicine University
UNKNOWN
Xiyuan Hospital of China Academy of Chinese Medical Sciences
OTHER
Sixth Affiliated Hospital, Sun Yat-sen University
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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2014ZSLYEC-021
Identifier Type: -
Identifier Source: org_study_id