TSTstarr + for Treatment of Severe Prolapsed Hemorrhoids --- a Multi-center Randomized Controlled… (NCT02295592) | Clinical Trial Compass
UnknownNot Applicable
TSTstarr + for Treatment of Severe Prolapsed Hemorrhoids --- a Multi-center Randomized Controlled Clinical Trail
780 participantsStarted 2014-11
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
the recurrence rate of the severe prolapsed Hemorrhoids after surgery
Timeframe: 2 years
Trial details
NCT IDNCT02295592
SponsorSixth Affiliated Hospital, Sun Yat-sen University