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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02295592
Recruitment Status : Unknown
Verified October 2014 by Sixth Affiliated Hospital, Sun Yat-sen University.
Recruitment status was:  Not yet recruiting
First Posted : November 20, 2014
Last Update Posted : November 20, 2014
Sponsor:
Collaborators:
Suzhou Touchstone International Medical Science Co.,Ltd.
Chengdu Anorectal Hospital
Wuhan University
Fujian Provincial Hospital
First Affiliated Hospital of Fujian Medical University
Nanhai Hospital of Traditional Chinese Medicine
Changshu Hospital of Traditional Chinese Medicine
Xuzhou Central Hospital
First Affiliated Hospital of Xinjiang Medical University
Shenyang Anorectal Hospital
Wulumuqi General Hospital of Lanzhou Military Command
The First Affiliated Hospital of Guangxi traditional Chinese Medicine University
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Information provided by (Responsible Party):
Sixth Affiliated Hospital, Sun Yat-sen University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hemorrhoids Procedure: TSTstarr+ Procedure: PPH Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 780 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : November 2014
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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 .
 Procedure: 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 .
Active Comparator: group B ( PPH group)
PPH is short fo procedure for prolapsed hemorrhoids .Patients in group B with severe prolapsed hemorrhoids will undergo PPH operation.
 Procedure: PPH
PPH is short fo procedure for prolapsed hemorrhoids .Patients in group B with severe prolapsed hemorrhoids will undergo PPH operation.


Outcome Measures
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Primary Outcome Measures :
  1. the recurrence rate of the severe prolapsed Hemorrhoids after surgery [ Time Frame: 2 years ]
    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


Secondary Outcome Measures :
  1. Operation time [ Time Frame: 1 year ]
  2. Intraoperative hemorrhage [ Time Frame: 1 year ]
  3. The weight of specimens [ Time Frame: 1year ]
  4. The volume of specimens [ Time Frame: 1year ]
  5. The number of patients with anal pain after surgery [ Time Frame: 2 years ]
  6. The number of patients with fecal urgency after surgery [ Time Frame: 2 years ]
  7. The number of patients with stricture of anus after surgery [ Time Frame: 2 years ]
  8. The number of patients with hemorrhage after surgery [ Time Frame: 2 years ]
  9. The number of patients with retention of urine in the early time after surgery [ Time Frame: 2 years ]
  10. The number of patients with edema of the anal margin in the early time after surgery [ Time Frame: 2 years ]
  11. The time of returning to normal [ Time Frame: 2 years ]
  12. The total cost of hospitalization [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02295592


Contacts
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Contact: Lin Hongcheng, Medicine Doctor +86 159158157 76 linhongcheng@hotmail.com

Sponsors and Collaborators
Sixth Affiliated Hospital, Sun Yat-sen University
Suzhou Touchstone International Medical Science Co.,Ltd.
Chengdu Anorectal Hospital
Wuhan University
Fujian Provincial Hospital
First Affiliated Hospital of Fujian Medical University
Nanhai Hospital of Traditional Chinese Medicine
Changshu Hospital of Traditional Chinese Medicine
Xuzhou Central Hospital
First Affiliated Hospital of Xinjiang Medical University
Shenyang Anorectal Hospital
Wulumuqi General Hospital of Lanzhou Military Command
The First Affiliated Hospital of Guangxi traditional Chinese Medicine University
Xiyuan Hospital of China Academy of Chinese Medical Sciences
More Information
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Responsible Party: Sixth Affiliated Hospital, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02295592    
Other Study ID Numbers: 2014ZSLYEC-021
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: November 20, 2014
Last Verified: October 2014
Keywords provided by Sixth Affiliated Hospital, Sun Yat-sen University:
hemorrhoids
The recurrence rate
PPH
TSTstarr+
Additional relevant MeSH terms:
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Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases