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

Primary Purpose

Hemorrhoids

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TSTstarr+
PPH
Sponsored by
Sixth Affiliated Hospital, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhoids focused on measuring hemorrhoids, The recurrence rate, PPH, TSTstarr+

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    group A( TSTstarr+ group)

    group B ( PPH group)

    Arm Description

    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 .

    PPH is short fo procedure for prolapsed hemorrhoids .Patients in group B with severe prolapsed hemorrhoids will undergo PPH operation.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Operation time
    Intraoperative hemorrhage
    The weight of specimens
    The volume of specimens
    The number of patients with anal pain after surgery
    The number of patients with fecal urgency after surgery
    The number of patients with stricture of anus after surgery
    The number of patients with hemorrhage after surgery
    The number of patients with retention of urine in the early time after surgery
    The number of patients with edema of the anal margin in the early time after surgery
    The time of returning to normal
    The total cost of hospitalization

    Full Information

    First Posted
    November 5, 2014
    Last Updated
    November 19, 2014
    Sponsor
    Sixth Affiliated Hospital, Sun Yat-sen University
    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
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02295592
    Brief Title
    TSTstarr + for Treatment of Severe Prolapsed Hemorrhoids --- a Multi-center Randomized Controlled Clinical Trail
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2014 (undefined)
    Primary Completion Date
    April 2016 (Anticipated)
    Study Completion Date
    October 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sixth Affiliated Hospital, Sun Yat-sen University
    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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hemorrhoids
    Keywords
    hemorrhoids, The recurrence rate, PPH, TSTstarr+

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    780 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    group A( TSTstarr+ group)
    Arm Type
    Experimental
    Arm Description
    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 .
    Arm Title
    group B ( PPH group)
    Arm Type
    Active Comparator
    Arm Description
    PPH is short fo procedure for prolapsed hemorrhoids .Patients in group B with severe prolapsed hemorrhoids will undergo PPH operation.
    Intervention Type
    Procedure
    Intervention Name(s)
    TSTstarr+
    Intervention Description
    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 .
    Intervention Type
    Procedure
    Intervention Name(s)
    PPH
    Intervention Description
    PPH is short fo procedure for prolapsed hemorrhoids .Patients in group B with severe prolapsed hemorrhoids will undergo PPH operation.
    Primary Outcome Measure Information:
    Title
    the recurrence rate of the severe prolapsed Hemorrhoids after surgery
    Description
    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
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Operation time
    Time Frame
    1 year
    Title
    Intraoperative hemorrhage
    Time Frame
    1 year
    Title
    The weight of specimens
    Time Frame
    1year
    Title
    The volume of specimens
    Time Frame
    1year
    Title
    The number of patients with anal pain after surgery
    Time Frame
    2 years
    Title
    The number of patients with fecal urgency after surgery
    Time Frame
    2 years
    Title
    The number of patients with stricture of anus after surgery
    Time Frame
    2 years
    Title
    The number of patients with hemorrhage after surgery
    Time Frame
    2 years
    Title
    The number of patients with retention of urine in the early time after surgery
    Time Frame
    2 years
    Title
    The number of patients with edema of the anal margin in the early time after surgery
    Time Frame
    2 years
    Title
    The time of returning to normal
    Time Frame
    2 years
    Title
    The total cost of hospitalization
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lin Hongcheng, Medicine Doctor
    Phone
    +86 159158157 76
    Email
    linhongcheng@hotmail.com

    12. IPD Sharing Statement

    Learn more about this trial

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

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