Clinical trial NCT02295592: TSTstarr + for Treatment of Severe Prolapsed Hemorrhoids --- a Multi-center Randomized Controlled Clinical Trail
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemorrhoids
Keywords: hemorrhoids
The recurrence rate
PPH
TSTstarr+
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Suzhou Touchstone International Medical Science Co.,Ltd.
name: Chengdu Anorectal Hospital
name: Wuhan University
name: Fujian Provincial Hospital
name: First Affiliated Hospital of Fujian Medical University
name: Nanhai Hospital of Traditional Chinese Medicine
name: Changshu Hospital of Traditional Chinese Medicine
name: Xuzhou Central Hospital
name: First Affiliated Hospital of Xinjiang Medical University
name: Shenyang Anorectal Hospital
name: Wulumuqi General Hospital of Lanzhou Military Command
name: The First Affiliated Hospital of Guangxi traditional Chinese Medicine University
name: Xiyuan Hospital of China Academy of Chinese Medical Sciences
First posted: 2014-11-20
Enrollment: 780
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: the recurrence rate of the severe prolapsed Hemorrhoids after surgery
timeFrame: 2 years
Secondary outcomes:
measure: Operation time
timeFrame: 1 year
measure: Intraoperative hemorrhage
timeFrame: 1 year
measure: The weight of specimens
timeFrame: 1year
measure: The volume of specimens
timeFrame: 1year
measure: The number of patients with anal pain after surgery
timeFrame: 2 years
measure: The number of patients with fecal urgency after surgery
timeFrame: 2 years
measure: The number of patients with stricture of anus after surgery
timeFrame: 2 years
measure: The number of patients with hemorrhage after surgery
timeFrame: 2 years
measure: The number of patients with retention of urine in the early time after surgery
timeFrame: 2 years
measure: The number of patients with edema of the anal margin in the early time after surgery
timeFrame: 2 years
measure: The time of returning to normal
timeFrame: 2 years
measure: The total cost of hospitalization
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References: