Recurrence Rate of Minimally Invasive Endoscopic Treatment of Internal Hemorrhoids

Internal Hemorrhoid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06250140
• Other study ID #: ShenzhenH
• Status: Not yet recruiting
• Start date: February 1, 2024
• Est. completion date: August 1, 2024

Study information

• Verified date: January 2024
• Source: Shenzhen Hospital of Southern Medical University
• Contact: Ying Zhu Ying Zhu, Professor
• Phone: +86 13384662039
• Email: zhuying1[@]smu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 900
• Est. completion date: August 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhoids
• Internal Hemorrhoid
• Recurrence

Intervention

Device:
• Tie up device
The recurrence rate of internal hemorrhoids in different treatment methods

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Shenzhen Hospital of Southern Medical University	964 hospital of joint Logistics Support Force, The Chinese people's liberation army army medical center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Recurrence rates of various treatment modalities in different grades		One year
Secondary	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