The Two Treatment Methods Compared the Sclerosing Agent Injection and the Rubber Wrapping

NCT05089500 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 984

Last updated 2021-10-22

No results posted yet for this study

Summary

This study is a prospective, multicentre, and randomized-controlled clinical study.The researchers wanted to explore the optimal treatment regimen for soft hemorrhoid within I-Ⅲ degrees by evaluating and comparing the effectiveness, safety and cost effect ratio of sclerosing injection and rubber lap ligation in patients with different internal hemorrhoid scores

Conditions

  • Hemorrhoid
  • Hemorrhoids
  • Hemorrhoids Internal
  • Hemorrhoid Prolapse
  • Hemorrhoid Bleeding
  • Hemorrhoid Pain

Interventions

OTHER

Endoscopic injection sclerotherapy

Patients were randomized assigned to the EIS group, preparing disposable endoscopic injections and sclerosing which were routinely administered with 1% polycinol.The transparent cap was fixed at the front end of the endoscope in inverted or orthofield of view.The stiffening agent or foam stiffer added to Meilan was injected with a disposable injection needle at 4-6 points at the oral end near the dentate line. Each point contained 0.2-1ml, and stopped after the hemorrhoid nucleus changed color. If necessary, a transparent cap was pressed to stop the bleeding to distribute the stiffening agent evenly.

OTHER

Endoscopic Band Ligation

Patients were randomized assigned to the EBL group and were to be prepared before surgery.After the socket is mounted at the inner lens end, the socket is obviously tied at 1-2cm hemorrhoids at the mouth above the dentate line, usually 2-4 rings.With mucosal prolapse, pericyclic multiple dislocation ligation can be performed 2-3cm above the obvious prolapse.

Sponsors & Collaborators

  • Zhejiang University

    collaborator OTHER
  • The First Affiliated Hospital of Nanchang University

    collaborator OTHER
  • Army Military Medical University Southwestern Hospital

    collaborator UNKNOWN
  • Shanxi Provincial Coal Central Hospital

    collaborator UNKNOWN
  • Hubei Hospital of Traditional Chinese Medicine

    collaborator OTHER
  • Wuhan Puren Hospital

    collaborator OTHER
  • Wuhan Tianyou Hospital

    collaborator UNKNOWN
  • Hanyang University

    collaborator OTHER
  • Enshi State Central Hospital

    collaborator UNKNOWN
  • Yichang Central People's Hospital

    collaborator OTHER
  • Central Hospital of Xiaogan

    collaborator OTHER
  • Xiaogan City First People's Hospital

    collaborator UNKNOWN
  • Fuyang City Second People's Hospital

    collaborator UNKNOWN
  • Chibi City People's Hospital

    collaborator UNKNOWN
  • Renmin Hospital of Wuhan University

    lead OTHER

Principal Investigators

  • Mingkai Chen, M.D · Renmin Hospital of Wuhan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2023-07-30
Completion
2023-09-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05089500 on ClinicalTrials.gov