Recurrence Rate of Minimally Invasive Endoscopic Treatment of Internal Hemorrhoids

A Multicenter Retrospective Study on the Recurrence Rate of Minimally Invasive Endoscopic Treatment of Internal Hemorrhoids

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

Study Overview

• Status: Not yet recruiting
• Conditions: Internal Hemorrhoid
• Intervention / Treatment: Device: Tie up device

• Study Type: Observational
• Enrollment (Estimated): 900

Contacts and Locations

• Study Contact: Name: Ying Zhu Ying Zhu, Professor; Phone Number: Y +86 13384662039; Email: zhuying1@smu.edu.cn
• Study Contact Backup: Name: Zheng Zewei Zewei Zheng, Professor; Phone Number: Zw +86 23360060; Email: szyyec@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

• 1. Age ≥18 years old, both sexes

  2, grade I-III internal hemorrhoids with symptoms related to internal hemorrhoids

  3. 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

Exclusion Criteria:

• 1. 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.

2. Patients with a history of allergy to narcotic drugs

3. Patients who were deemed by the investigator to be ineligible for participation in the trial

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Internal hemorrhoid ligation group; Endoscopic internal hemorrhoid ligation	Device: Tie up device; The recurrence rate of internal hemorrhoids in different treatment methods
Hemorrhoids injection group; Endoscopic hemorrhoid injection was performed	Device: Tie up device; The recurrence rate of internal hemorrhoids in different treatment methods
Internal hemorrhoids combined treatment group; Lines of endoscopic hemorrhoids and internal ligation under endoscope to injection	Device: Tie up device; The recurrence rate of internal hemorrhoids in different treatment methods

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The overall efficacy of various treatment methods	(1) Cure: the symptoms of hematochezia and prolapse disappeared completely. (2) Remarkable effect: the symptoms of hematochezia and prolapse were significantly improved, or the symptoms were alleviated but the frequency and degree of attack were reduced compared with those before operation; (3) Ineffective: the symptoms of hematochezia and prolapse were not relieved or even aggravated. Total effective rate = (cure + marked effective)/total ratio X100%	One year
Recurrence rates of various treatment modalities in different grades		One year
The efficacy of sequential treatment after recurrence was evaluated	Patients with internal hemorrhoids who had preoperative clinical symptoms (bleeding, prolapse, pain, etc.) at more than 3 months after operation, and failed to be relieved by conservative treatment, needed endoscopic sclerotherapy, ligation, ligation sclerotherapy or surgery again were regarded as recurrence. Total effective rate = (cure + marked effective)/total ratio X100%	One year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: January 22, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Recurrence; Hemorrhoids
• Other Study ID Numbers: ShenzhenH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No