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临床试验/NCT06794151
NCT06794151进行中(未招募)不适用

Endoscopic Rubber Band Ligation and Milligan-Morgan Hemorrhoidectomy for the Treatment of Grade II-III Internal Hemorrhoids: a Multicenter, Non-randomized Controlled Study

Weidong Tong1 个研究点 分布在 1 个国家目标入组 548 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
548
试验地点
1
主要终点
Efficacy Rate

研究概览

简要总结

This study adopted a multicenter, non-randomized controlled clinical research design. Patients with internal hemorrhoids who met the inclusion criteria were assigned to the endoscopic rubber band ligation group (observation group) or the Milligan-Morgan hemorrhoidectomy group (control group) according to their treatment preferences. Doctors who were unaware of the clinical data information evaluated the patients' postoperative recovery, the occurrence of complications, and the long-term follow-up of treatment efficacy through outpatient reexaminations, WeChat video calls, or telephone calls.

Research Subjects and Inclusion/Exclusion Criteria 1.1 Research Subjects Patients with grade II-III internal hemorrhoids 1.2 Inclusion Criteria

  1. Patients diagnosed with grade II-III internal hemorrhoids according to the Goligher classification;
  2. Aged between 18 and 80 years old, both males and females;
  3. Those who did not respond well to conservative treatments such as dietary adjustments and medications;
  4. Patients who signed the informed consent form and were willing to cooperate with this study.

1.3 Exclusion Criteria

  1. Patients with contraindications to colonoscopy;
  2. Patients with concurrent anorectal diseases such as anal fissure, anal fistula, thrombosed hemorrhoids, perianal abscess, etc., or a history of previous anorectal surgery;
  3. Pregnant patients;
  4. Patients with concurrent intestinal infections, inflammatory bowel diseases, or colorectal malignancies;
  5. Patients with severe heart, liver, or kidney diseases and coagulation disorders;
  6. Patients with diabetes mellitus and poor blood glucose control;
  7. Patients with missing clinical data, poor follow-up compliance, or those suffering from mental illnesses and communication disorders;
  8. Patients who refused to participate in the study. 1.4 Observation Indicators Primary Indicator: Efficacy Rate Secondary Indicators: Pain, a feeling of fullness and discomfort in the anus, urinary retention, defecation status, long-term therapeutic effect, treatment cost, etc.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •(1) Patients diagnosed with grade II-III internal hemorrhoids according to the Goligher classification; (2) Aged between 18 and 80 years old, both males and females; (3) Those who did not respond well to conservative treatments such as dietary adjustments and medications; (4) Patients who signed the informed consent form and were willing to cooperate with this study.

排除标准

  • •(1) Patients with contraindications to colonoscopy; (2) Patients with concurrent anorectal diseases such as anal fissure, anal fistula, thrombosed hemorrhoids, perianal abscess, etc., or a history of previous anorectal surgery; (3) Pregnant patients; (4) Patients with concurrent intestinal infections, inflammatory bowel diseases, or colorectal malignancies; (5) Patients with severe heart, liver, or kidney diseases and coagulation disorders; (6) Patients with diabetes mellitus and poor blood glucose control; (7) Patients with missing clinical data, poor follow-up compliance, or those suffering from mental illnesses and communication disorders; (8) Patients who refused to participate in the study.

结局指标

主要结局

Efficacy Rate

时间窗: 6 months

The primary endpoint of this study is to evaluate the therapeutic effect of hemorrhoids in patients through physical examinations, digital rectal examinations and other means by doctors who are unaware of the clinical data information six months after the operation.

次要结局

未报告次要终点

研究者

发起方
Weidong Tong
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Weidong Tong

Endoscopic Rubber Band Ligation and Milligan-Morgan Hemorrhoidectomy for the Treatment of Grade II-III Internal Hemorrhoids: A Multicenter, Non-randomized Controlled Study

Third Military Medical University

研究点 (1)

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