TSTstarr + for Treatment of Severe Prolapsed Hemorrhoids --- a Multi-center Randomized Controlled Clinical Trail

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02295592

Collaborator

Suzhou Touchstone International Medical Science Co.,Ltd. (Other), Chengdu Anorectal Hospital (Other), Wuhan University (Other), Fujian Provincial Hospital (Other), First Affiliated Hospital of Fujian Medical University (Other), Nanhai Hospital of Traditional Chinese Medicine (Other), Changshu Hospital of Traditional Chinese Medicine (Other), Xuzhou Central Hospital (Other), First Affiliated Hospital of Xinjiang Medical University (Other), Shenyang Anorectal Hospital (Other), Wulumuqi General Hospital of Lanzhou Military Command (Other), The First Affiliated Hospital of Guangxi traditional Chinese Medicine University (Other), Xiyuan Hospital of China Academy of Chinese Medical Sciences (Other)

780

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemorrhoids	Procedure: TSTstarr+ Procedure: PPH	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

780 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Study Start Date :

Nov 1, 2014

Anticipated Primary Completion Date :

Apr 1, 2016

Anticipated Study Completion Date :

Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: group A( TSTstarr+ group) 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 .	Procedure: 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 .
Active Comparator: group B ( PPH group) PPH is short fo procedure for prolapsed hemorrhoids .Patients in group B with severe prolapsed hemorrhoids will undergo PPH operation.	Procedure: PPH PPH is short fo procedure for prolapsed hemorrhoids .Patients in group B with severe prolapsed hemorrhoids will undergo PPH operation.

Arm

Intervention/Treatment

Experimental: group A( TSTstarr+ group)

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 .

Procedure: 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 .

Active Comparator: group B ( PPH group)

PPH is short fo procedure for prolapsed hemorrhoids .Patients in group B with severe prolapsed hemorrhoids will undergo PPH operation.

Procedure: PPH

PPH is short fo procedure for prolapsed hemorrhoids .Patients in group B with severe prolapsed hemorrhoids will undergo PPH operation.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]
The number of patients with fecal urgency after surgery [2 years]
The number of patients with stricture of anus after surgery [2 years]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Sixth Affiliated Hospital, Sun Yat-sen University
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