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

Sun Yat-sen University

Status: Unknown

Conditions: Hemorrhoids

Treatments: Procedure: TSTstarr+; Procedure: PPH

Study type: Interventional

Funder types: Other

Identifiers

NCT02295592

2014ZSLYEC-021

Details and patient eligibility

About

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.

Enrollment: 780 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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780 participants in 2 patient groups

group A( TSTstarr+ group)

Experimental group

Description:

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 .

Treatment:

Procedure: TSTstarr+

group B ( PPH group)

Active Comparator group

Description:

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

Treatment:

Procedure: PPH