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

Hemorrhoids Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02295592
• Other study ID #: 2014ZSLYEC-021
• Status: Not yet recruiting
• Phase: N/A
• First received: November 5, 2014
• Last updated: November 19, 2014
• Start date: November 2014
• Est. completion date: October 2016

Study information

• Verified date: October 2014
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Lin Hongcheng, Medicine Doctor
• Phone: +86 159158157 76
• Email: linhongcheng[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee of The Sixth Affiliated Hospital of Sun Yet-sen University
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 780
• Est. completion date: October 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhoids

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (14)

Lead Sponsor

Collaborator

Sixth Affiliated Hospital, Sun Yat-sen University

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the recurrence rate of the severe prolapsed Hemorrhoids after surgery	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	2 years	No
Secondary	Operation time		1 year	Yes
Secondary	Intraoperative hemorrhage		1 year	Yes
Secondary	The weight of specimens		1year	Yes
Secondary	The volume of specimens		1year	Yes
Secondary	The number of patients with anal pain after surgery		2 years	Yes
Secondary	The number of patients with fecal urgency after surgery		2 years	Yes
Secondary	The number of patients with stricture of anus after surgery		2 years	Yes
Secondary	The number of patients with hemorrhage after surgery		2 years	Yes
Secondary	The number of patients with retention of urine in the early time after surgery		2 years	Yes
Secondary	The number of patients with edema of the anal margin in the early time after surgery		2 years	No
Secondary	The time of returning to normal		2 years	No
Secondary	The total cost of hospitalization		2 years	No