Hemorrhoids
Conditions
Keywords
hemorrhoids, The recurrence rate, PPH, TSTstarr+
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.
Interventions
PROCEDURETSTstarr+
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 .
PROCEDUREPPH
PPH is short fo procedure for prolapsed hemorrhoids .Patients in group B with severe prolapsed hemorrhoids will undergo PPH operation.
Sponsors
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
The First Affiliated Hospital of Guangxi traditional Chinese Medicine University
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the recurrence rate of the severe prolapsed Hemorrhoids after surgery | 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| The number of patients with fecal urgency after surgery | 2 years |
| Operation time | 1 year |
| The number of patients with hemorrhage after surgery | 2 years |
| The number of patients with retention of urine in the early time after surgery | 2 years |
| The number of patients with edema of the anal margin in the early time after surgery | 2 years |
| The time of returning to normal | 2 years |
| The total cost of hospitalization | 2 years |
| The number of patients with stricture of anus after surgery | 2 years |
Contacts
Primary ContactLin Hongcheng, Medicine Doctor
Outcome results
None listed