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| Name | Class |
|---|---|
| 964 hospital of joint Logistics Support Force | UNKNOWN |
| The Chinese people's liberation army army medical center | UNKNOWN |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Internal hemorrhoid ligation group | Endoscopic internal hemorrhoid ligation |
| |
| Hemorrhoids injection group | Endoscopic hemorrhoid injection was performed |
| |
| Internal hemorrhoids combined treatment group | Lines of endoscopic hemorrhoids and internal ligation under endoscope to injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tie up device | Device | The recurrence rate of internal hemorrhoids in different treatment methods |
|
| 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 |
| 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% |
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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:
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
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Patients with internal hemorrhoids who had undergone endoscopic treatment for internal hemorrhoids could be enrolled in the study after informed consent was obtained
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Zhu Ying Zhu, Professor | Contact | +86 13384662039 | Y | zhuying1@smu.edu.cn |
| Zheng Zewei Zewei Zheng, Professor | Contact | +86 23360060 | Zw | szyyec@163.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41987169 | Derived | Huang X, Xu W, Lin H, Jiang P, Yang H, Chen L, Yang K, Huang Y, Zhu Y, Liu J. Evaluation of short-term outcomes of Endoscopic Super-Hemorrhoidal Banding for mixed hemorrhoids with prolapsed internal hemorrhoids: a retrospective study. BMC Surg. 2026 Apr 15;26(1):363. doi: 10.1186/s12893-026-03744-z. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 14, 2023 | Jan 31, 2024 | ICF_000.pdf |
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| 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 |