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

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.

Conditions

• Hemorrhoids

Interventions

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 .

PROCEDURE

PPH

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

Sponsors & Collaborators

• Suzhou Touchstone International Medical Science Co.,Ltd.

  collaborator UNKNOWN

• Chengdu Anorectal Hospital

  collaborator UNKNOWN

• Wuhan University

  collaborator OTHER

• Fujian Provincial Hospital

  collaborator OTHER

• First Affiliated Hospital of Fujian Medical University

  collaborator OTHER

• Nanhai Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Changshu Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Xuzhou Central Hospital

  collaborator OTHER

• First Affiliated Hospital of Xinjiang Medical University

  collaborator OTHER

• Shenyang Anorectal Hospital

  collaborator OTHER

• Wulumuqi General Hospital of Lanzhou Military Command

  collaborator OTHER

• The First Affiliated Hospital of Guangxi traditional Chinese Medicine University

  collaborator UNKNOWN

• Xiyuan Hospital of China Academy of Chinese Medical Sciences

  collaborator OTHER

• Sixth Affiliated Hospital, Sun Yat-sen University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-11-30

Primary Completion

2016-04-30

Completion

2016-10-31