TSTstarr + for Treatment of Severe Prolapsed Hemorrhoids --- a Multi-center Randomized Controlled Clinical Trail
1 other identifier
interventional
780
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2014
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 5, 2014
CompletedFirst Posted
Study publicly available on registry
November 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedNovember 20, 2014
October 1, 2014
1.4 years
November 5, 2014
November 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
2 years
Secondary Outcomes (12)
Operation time
1 year
Intraoperative hemorrhage
1 year
The weight of specimens
1year
The volume of specimens
1year
The number of patients with anal pain after surgery
2 years
- +7 more secondary outcomes
Study Arms (2)
group A( TSTstarr+ group)
EXPERIMENTALTSTstarr+ 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 COMPARATORPPH is short fo procedure for prolapsed hemorrhoids .Patients in group B with severe prolapsed hemorrhoids will undergo PPH operation.
Interventions
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 .
PPH is short fo procedure for prolapsed hemorrhoids .Patients in group B with severe prolapsed hemorrhoids will undergo PPH operation.
Eligibility Criteria
You may qualify if:
- severe prolapsed hemorrhoids
- no significant anal-malformation before operation
- having signed the informed consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sixth Affiliated Hospital, Sun Yat-sen Universitylead
- Suzhou Touchstone International Medical Science Co.,Ltd.collaborator
- Chengdu Anorectal Hospitalcollaborator
- Wuhan Universitycollaborator
- Fujian Provincial Hospitalcollaborator
- First Affiliated Hospital of Fujian Medical Universitycollaborator
- Nanhai Hospital of Traditional Chinese Medicinecollaborator
- Changshu Hospital of Traditional Chinese Medicinecollaborator
- Xuzhou Central Hospitalcollaborator
- First Affiliated Hospital of Xinjiang Medical Universitycollaborator
- Shenyang Anorectal Hospitalcollaborator
- Wulumuqi General Hospital of Lanzhou Military Commandcollaborator
- The First Affiliated Hospital of Guangxi traditional Chinese Medicine Universitycollaborator
- Xiyuan Hospital of China Academy of Chinese Medical Sciencescollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2014
First Posted
November 20, 2014
Study Start
November 1, 2014
Primary Completion
April 1, 2016
Study Completion
October 1, 2016
Last Updated
November 20, 2014
Record last verified: 2014-10