A Comparative Clinical Study To Evaluate Efficacy Of Hemorrhoidectomy Versus Finger Guided Hemorrhoidal Artery Ligation In The Management Of Grade III Hemorrhoids
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
This is a prospective, randomized, open-label comparative clinical study conducted at Jammu Institute of Ayurveda and Research, Jammu, to evaluate and compare the efficacy, safety, and postoperative outcomes of Milligan–Morgan Hemorrhoidectomy versus Finger-Guided Hemorrhoidal Artery Ligation (FGHAL) with mucopexy in patients suffering from Grade III internal hemorrhoids (Arsha Roga).
A total of 40 patients aged 18–70 years with clinically diagnosed Grade III hemorrhoids will be enrolled and randomly allocated into two groups:
• Group A (n=20): Milligan–Morgan Hemorrhoidectomy
• Group B (n=20): Finger-Guided Hemorrhoidal Artery Ligation with Mucopexy
The study duration is 18 months, with each patient followed for 90 days post-procedure. Primary outcome measure is recurrence at 90 days. Secondary outcomes include postoperative pain (VAS score), intra-operative blood loss, operative time, analgesic requirement, hospital stay, time to return to normal activities, and postoperative complications.
Assessments will be performed at 24 hours, 48 hours, 7 days, 30 days, 60 days, and 90 days. Statistical analysis will be carried out using SPSS software.
The study aims to determine whether FGHAL offers a better postoperative recovery profile with comparable efficacy, or whether conventional hemorrhoidectomy provides superior disease control despite higher morbidity. Institutional Ethical Committee approval has been obtained prior to initiation of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged between 18 and 70 years
- •Patients of either sex
- •Patients with primary hemorrhoids
- •Patients clinically diagnosed with Grade III internal hemorrhoids
- •Patients who are medically fit for surgery under spinal anesthesia
- •Patients who are willing and able to provide written, informed consent.
排除标准
- •Patients with Grade I, II, or IV hemorrhoids
- •Patients with a history of previous surgery for any anal disorder
- •Patients presenting with acute complications such as thrombosed or strangulated hemorrhoids
- •Patients with Significant fecal incontinence
- •Patients with other active anorectal diseases, including chronic anal fissure with severe sphincter spasm, fistula-in-ano, or perianal abscess
- •Patients with known coagulopathies or on therapeutic anticoagulation that cannot be safely discontinued
- •Pregnant or lactating women
- •Patients with an altered cognitive status who are unable to provide informed consent.
研究者
Dr Abhinandan Manhas
Jammu Institute of Ayurveda and Research