A Multicenter Prospective Clinical Study of Endoscopic Foam Sclerotherapy for Internal Hemorrhoids

Summary

"Internal hemorrhoid" affects the quality of life due to hemorrhage and prolapse as a common and frequently-occurring disease. Endoscopic sclerosing agent injection has replaced traditional surgery and become the most commonly used treatment method in developed countries. At present, how to reduce the side effects of sclerosing agent and accurately determine the injection site and depth has become a difficult clinical problem. The research group creatively put forward the theory of foam sclerosing agent to treat internal hemorrhoids in the early stage. With the aid of transparent cap, the visibility of surgical field of vision can be improved. The mini probe ultrasound (MPS) is proposed to effectively evaluate the submucosal in

Conditions

• Grade/Stage I Hemorrhoids
• Prolapsed Grade II Internal Haemorrhoid
• Prolapsed Grade III Internal Haemorrhoid

Interventions

DRUG

Sclerosing foam of Lauromacrogol

Participants in FS will receive enteroscopy with the sclerosing foam of lauromacrogol.

DRUG

Sclersing liqiud of Lauromacrogol

Participants in LS will receive enteroscopy with the sclerosing liquid of lauromacrogol.

Sponsors & Collaborators

• Tongren Hospital,Shanghai Jiao Tong University School of Medicine

  collaborator UNKNOWN

• Shanghai Construction Group Hospital

  collaborator UNKNOWN

• Shandong Maternal and Chidl Care Service Center

  collaborator UNKNOWN

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

  collaborator OTHER

• West China Forth University Hospital，Sichuan University

  collaborator UNKNOWN

• The First Hospital of Anhui Medical University

  collaborator UNKNOWN

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Jiangsu Provincial Second Chinese Medicine Hospital

  collaborator UNKNOWN

• Anhui Provincial Hospital

  collaborator OTHER_GOV

• Luoyang Central Hospital

  collaborator OTHER

• Ganzhou Fifth pepole's Hospital

  collaborator UNKNOWN

• Changzhi People's Hospital

  collaborator OTHER

• Nanjing PLA General Hospital

  collaborator OTHER

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  lead OTHER

Principal Investigators

• Leiming Xu · Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

• Yi Zhang · Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

• Zhenzhong Deng · Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

• Haixia Peng · Tong Ren Hospital affiliated to Shanghai Jiaotong University School of Medicine

• Hui Pan · Shanghai Construction Group Hospital

• Fengyu Gao · Shandong Maternal and Child Health Center affiliated to Shandong University

• Hao Zhang · BaoShan People's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-05-15

Primary Completion

2020-12-31

Completion

2021-12-31

Countries

• China

Study Locations