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

Study Description

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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

Arms and Interventions

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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

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Primary Outcome Measures :

1. 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 :

1. Operation time [ Time Frame: 1 year ]
2. Intraoperative hemorrhage [ Time Frame: 1 year ]
3. The weight of specimens [ Time Frame: 1year ]
4. The volume of specimens [ Time Frame: 1year ]
5. The number of patients with anal pain after surgery [ Time Frame: 2 years ]
6. The number of patients with fecal urgency after surgery [ Time Frame: 2 years ]
7. The number of patients with stricture of anus after surgery [ Time Frame: 2 years ]
8. The number of patients with hemorrhage after surgery [ Time Frame: 2 years ]
9. The number of patients with retention of urine in the early time after surgery [ Time Frame: 2 years ]
10. The number of patients with edema of the anal margin in the early time after surgery [ Time Frame: 2 years ]
11. The time of returning to normal [ Time Frame: 2 years ]
12. 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)
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

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

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Sixth Affiliated Hospital, Sun Yat-sen University
ClinicalTrials.gov Identifier:	NCT02295592 History of Changes
Other Study ID Numbers:	2014ZSLYEC-021
First Posted:	November 20, 2014
Last Update Posted:	November 20, 2014
Last Verified:	October 2014

Keywords provided by Sixth Affiliated Hospital, Sun Yat-sen University:

hemorrhoids; The recurrence rate; PPH; TSTstarr+

Additional relevant MeSH terms:

Hemorrhoids; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases	Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases