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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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06250140
Enrollment
900
Registered
2024-02-08
Start date
2024-02-01
Completion date
2024-08-01
Last updated
2024-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Internal Hemorrhoid

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

Interventions

DEVICETie up device

The recurrence rate of internal hemorrhoids in different treatment methods

Sponsors

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

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Recurrence rate of minimally invasive endoscopic treatmentOne yearIf 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%

Secondary

MeasureTime frameDescription
The overall efficacy of various treatment methodsOne year(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%
Recurrence rates of various treatment modalities in different gradesOne year
The efficacy of sequential treatment after recurrence was evaluatedOne yearPatients 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%

Contacts

Primary ContactYing Zhu Ying Zhu, Professor
zhuying1@smu.edu.cn+86 13384662039
Backup ContactZheng Zewei Zewei Zheng, Professor
szyyec@163.com+86 23360060

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 17, 2026