Status:

UNKNOWN

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

Lead Sponsor:

Sixth Affiliated Hospital, Sun Yat-sen University

Collaborating Sponsors:

Suzhou Touchstone International Medical Science Co.,Ltd.

Chengdu Anorectal Hospital

Conditions:

Hemorrhoids

Eligibility:

All Genders

18-65 years

Phase:

NA

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...

Eligibility Criteria

Inclusion

  • severe prolapsed hemorrhoids
  • no significant anal-malformation before operation
  • having signed the informed consent.

Exclusion

  • 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.

Key Trial Info

Start Date :

November 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 1 2016

Estimated Enrollment :

780 Patients enrolled

Trial Details

Trial ID

NCT02295592

Start Date

November 1 2014

End Date

October 1 2016

Last Update

November 20 2014

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