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

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.

Study Overview

• Status: Unknown
• Conditions: Hemorrhoids
• Intervention / Treatment: Procedure: TSTstarr+; Procedure: PPH

• Study Type: Interventional
• Enrollment (Anticipated): 780
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lin Hongcheng, Medicine Doctor; Phone Number: +86 159158157 76; Email: linhongcheng@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
• Collaborators: Wuhan University; First Affiliated Hospital of Fujian Medical University; Xiyuan Hospital of China Academy of Chinese Medical Sciences; Xuzhou Central Hospital; First Affiliated Hospital of Xinjiang Medical University; Fujian Provincial Hospital; Wulumuqi General Hospital of Lanzhou Military Command; Shenyang Anorectal Hospital; Nanhai Hospital of Traditional Chinese Medicine; Changshu Hospital of Traditional Chinese Medicine; Suzhou Touchstone International Medical Science Co.,Ltd.; Chengdu Anorectal Hospital; The First Affiliated Hospital of Guangxi traditional Chinese Medicine University

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (ANTICIPATED): April 1, 2016
• Study Completion (ANTICIPATED): October 1, 2016

Study Registration Dates

• First Submitted: November 5, 2014
• First Submitted That Met QC Criteria: November 19, 2014
• First Posted (ESTIMATE): November 20, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): November 20, 2014
• Last Update Submitted That Met QC Criteria: November 19, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: hemorrhoids; PPH; The recurrence rate; TSTstarr+
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Hemorrhoids
• Other Study ID Numbers: 2014ZSLYEC-021