Recurrence Rate of Minimally Invasive Endoscopic Treatment of Internal Hemorrhoids
- Conditions
- Internal Hemorrhoid
- Interventions
- Device: Tie up device
- Registration Number
- NCT06250140
- Lead Sponsor
- Shenzhen Hospital of Southern Medical University
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 900
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- Age ≥18 years old, both sexes
2, 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
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- 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.
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Patients with a history of allergy to narcotic drugs
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Patients who were deemed by the investigator to be ineligible for participation in the trial
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Hemorrhoids injection group Tie up device Endoscopic hemorrhoid injection was performed Internal hemorrhoid ligation group Tie up device Endoscopic internal hemorrhoid ligation Internal hemorrhoids combined treatment group Tie up device Lines of endoscopic hemorrhoids and internal ligation under endoscope to injection
- Primary Outcome Measures
Name Time Method Recurrence rate of minimally invasive endoscopic treatment One year 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%
- Secondary Outcome Measures
Name Time Method The overall efficacy of various treatment methods One 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 grades One year The efficacy of sequential treatment after recurrence was evaluated One year 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%