Recurrence Rate of Minimally Invasive Endoscopic Treatment of Internal Hemorrhoids

NCT06250140 | Unknown FDA Device

• 1 other identifier: ShenzhenH
• Study Type: observational
• Target: 900
• Locations: 0 countries
• Sites: N/A

Brief Summary

2.1 Main objective: To observe the short-term and long-term recurrence rates of various endoscopic minimally invasive treatment methods for internal hemorrhoids and different time points of endoscopic minimally invasive treatment for internal hemorrhoids in patients with grade I-III internal hemorrhoids 2.2 Secondary objective: To observe the safety and efficacy of endoscopic minimally invasive treatment of internal hemorrhoids

Conditions

Internal Hemorrhoid

Outcome Measures

Primary Outcomes (1)

• Recurrence rate of minimally invasive endoscopic treatment

  If patients with internal hemorrhoids recurred with preoperative clinical symptoms (bleeding, prolapse, pain, etc.), which could not be relieved by conservative treatment, and needed endoscopic sclerotherapy, ligation, ligation sclerotherapy or surgery again, the recurrence rate = the number of recurrent cases/the number of patients X100%

  One year

Secondary Outcomes (3)

• The overall efficacy of various treatment methods

  One year

• Recurrence rates of various treatment modalities in different grades

  One year

• The efficacy of sequential treatment after recurrence was evaluated

  One year

Study Arms (3)

Internal hemorrhoid ligation group

Endoscopic internal hemorrhoid ligation

Device: Tie up device

Hemorrhoids injection group

Endoscopic hemorrhoid injection was performed

Device: Tie up device

Internal hemorrhoids combined treatment group

Lines of endoscopic hemorrhoids and internal ligation under endoscope to injection

Device: Tie up device

Interventions

Tie up device DEVICE

The recurrence rate of internal hemorrhoids in different treatment methods

Hemorrhoids injection group; Internal hemorrhoid ligation group; Internal hemorrhoids combined treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with internal hemorrhoids who had undergone endoscopic treatment for internal hemorrhoids could be enrolled in the study after informed consent was obtained

You may qualify if:

• \. Age ≥18 years old, both sexes
• , grade I-III internal hemorrhoids with symptoms related to internal hemorrhoids
• \. The purpose and adverse consequences of endoscopic minimally invasive treatment of internal hemorrhoids have been fully understood before surgery, and the informed consent for endoscopic minimally invasive treatment of internal hemorrhoids has been signed

You may not qualify if:

• \. Patients with contraindications to endoscopic minimally invasive treatment (1) grade IV internal hemorrhoids, mixed hemorrhoids and external hemorrhoids; (2) I-III
• Degree of internal hemorrhoids with incarceration, thrombosis, erosion, infection, etc. (3) patients with severe systemic diseases could not tolerate endoscopic treatment; (4) accompanied by crissum infectious disease, anal fistula, and inflammatory bowel disease activity, etc.; (5) in menstrual period, pregnancy and puerperium, (6) patients with sclerotherapy allergy; (7) function of blood coagulation disorder or are using anticoagulant drugs.
• \. Patients with a history of allergy to narcotic drugs
• \. Patients who were deemed by the investigator to be ineligible for participation in the trial

Sponsors & Collaborators

• Shenzhen Hospital of Southern Medical University: lead
• 964 hospital of joint Logistics Support Force: collaborator
• The Chinese people's liberation army army medical center: collaborator

Central Study Contacts

Ying Zhu Ying Zhu, Professor

CONTACT

+86 13384662039; zhuying1@smu.edu.cn

Zheng Zewei Zewei Zheng, Professor

CONTACT

+86 23360060; szyyec@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 8, 2024
• Study Start: February 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: August 1, 2024
• Last Updated: February 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share