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

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ClinicalTrials.gov Identifier: NCT02295592

Recruitment Status : Unknown

Verified October 2014 by Sixth Affiliated Hospital, Sun Yat-sen University.
Recruitment status was: Not yet recruiting

First Posted : November 20, 2014

Last Update Posted : November 20, 2014

Sponsor:

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

The First Affiliated Hospital of Guangxi traditional Chinese Medicine University

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Information provided by (Responsible Party):

Sixth Affiliated Hospital, Sun Yat-sen University

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	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	780 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Study Start Date :	November 2014
Estimated Primary Completion Date :	April 2016
Estimated Study Completion Date :	October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

U.S. FDA Resources

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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02295592

Contacts

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Contact: Lin Hongcheng, Medicine Doctor	+86 159158157 76	linhongcheng@hotmail.com

Sponsors and Collaborators