HemorrhoidsNCT02295592
TSTstarr + for Treatment of Severe Prolapsed Hemorrhoids --- a Multi-center Randomized Controlled Clinical Trail
A study testing TSTstarr+ and PPH in people with Hemorrhoids, run by Sixth Affiliated Hospital, Sun Yat-sen University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- TSTstarr+ and PPH
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 780 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- severe prolapsed hemorrhoids
- no significant anal-malformation before operation
- having signed the informed consent.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Hemorrhoids
- Being tested
- TSTstarr+, PPH
- Keywords
- hemorrhoids, The recurrence rate, PPH, TSTstarr+
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TSTstarr+Procedure or surgery
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 .
PPHProcedure or surgery
PPH is short fo procedure for prolapsed hemorrhoids .Patients in group B with severe prolapsed hemorrhoids will undergo PPH operation.
| Study group | Role | What they receive |
|---|---|---|
| group A( TSTstarr+ group) | Experimental | 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 . Receives: Procedure: TSTstarr+ |
| group B ( PPH group) | Active comparator | PPH is short fo procedure for prolapsed hemorrhoids .Patients in group B with severe prolapsed hemorrhoids will undergo PPH operation. Receives: Procedure: PPH |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (12)
Operation time
Measured: 1 year
Intraoperative hemorrhage
Measured: 1 year
The weight of specimens
Measured: 1year
The volume of specimens
Measured: 1year
The number of patients with anal pain after surgery
Measured: 2 years
The number of patients with fecal urgency after surgery
Measured: 2 years
The number of patients with stricture of anus after surgery
Measured: 2 years
The number of patients with hemorrhage after surgery
Measured: 2 years
The number of patients with retention of urine in the early time after surgery
Measured: 2 years
The number of patients with edema of the anal margin in the early time after surgery
Measured: 2 years
The time of returning to normal
Measured: 2 years
The total cost of hospitalization
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionApr 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 780 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- 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, First Affiliated Hospital of Guangxi Medical University, Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295592
- Sponsor's protocol ID
- 2014ZSLYEC-021
- Status last verified
- Oct 2014
- First submitted
- 5 Nov 2014
- Last updated
- 20 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TSTstarr + for Treatment of Severe Prolapsed Hemorrhoids --- a Multi-center Randomized Controlled Clinical Trail
- ClinicalTrials.gov ID
- NCT02295592
- Acronym / sponsor ID
- 2014ZSLYEC-021
- Conditions
- Hemorrhoids
- Keywords
- hemorrhoids, The recurrence rate, PPH, TSTstarr+
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 780 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- 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, First Affiliated Hospital of Guangxi Medical University, Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Study start
- Nov 2014
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A( TSTstarr+ group) | Experimental | Procedure: TSTstarr+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 . |
| group B ( PPH group) | Active comparator | Procedure: PPHPPH is short fo procedure for prolapsed hemorrhoids .Patients in group B with severe prolapsed hemorrhoids will undergo PPH operation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- severe prolapsed hemorrhoids
- no significant anal-malformation before operation
- having signed the informed consent.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 . | Procedure or surgery | group A( TSTstarr+ group) |
| PPHPPH is short fo procedure for prolapsed hemorrhoids .Patients in group B with severe prolapsed hemorrhoids will undergo PPH operation. | Procedure or surgery | group B ( PPH group) |
Primary outcome
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
12 secondary outcomes
Operation time
Time frame: 1 year
Intraoperative hemorrhage
Time frame: 1 year
The weight of specimens
Time frame: 1year
The volume of specimens
Time frame: 1year
The number of patients with anal pain after surgery
Time frame: 2 years
The number of patients with fecal urgency after surgery
Time frame: 2 years
The number of patients with stricture of anus after surgery
Time frame: 2 years
The number of patients with hemorrhage after surgery
Time frame: 2 years
The number of patients with retention of urine in the early time after surgery
Time frame: 2 years
The number of patients with edema of the anal margin in the early time after surgery
Time frame: 2 years
The time of returning to normal
Time frame: 2 years
The total cost of hospitalization
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing TSTstarr+ and PPH in people with Hemorrhoids, run by Sixth Affiliated Hospital, Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Hongcheng, Medicine Doctor (+86 159158157 76, linhongcheng@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the recurrence rate of the severe prolapsed Hemorrhoids after surgery (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2014.