Sutureless Hemorrhoidectomy Versus Conventional Ligation: A Comparative Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Postoperative Pain Score
研究概览
简要总结
Hemorrhoidal disease is a frequent benign anorectal ailment in surgical practice. Conventional excisional hemorrhoidectomy using the Milligan-Morgan technique remains effective but is significantly limited by severe postoperative pain and related complications. Sutureless hemorrhoidectomy utilizing energy-based vessel sealing devices (such as LigaSure or Harmonic Scalpel) aims to minimize tissue trauma, blood loss, and postoperative discomfort. This prospective comparative randomized clinical trial aims to evaluate and compare the perioperative and postoperative outcomes of sutureless hemorrhoidectomy versus conventional ligation hemorrhoidectomy in adult patients with advanced (grades III and IV) hemorrhoidal disease.
详细描述
Symptomatic advanced hemorrhoids (grades III-IV) frequently require excisional surgical intervention. Traditional ligation techniques involve pedicle transfixion that often exacerbates postoperative pain, anal spasms, and urinary retention. Energy-based vessel sealing systems provide reliable pedicle occlusion without conventional transfixion or suture ligation, potentially expediting operative time and recovery. In this prospective randomized study conducted at the Department of General Surgery, Sohag University Hospital, 50 eligible adult patients with symptomatic grade III-IV hemorrhoidal disease will be randomly allocated (1:1) into two equal groups: Group A (n=25): Sutureless hemorrhoidectomy using an energy-based vessel sealing device. Group B (n=25): Conventional ligation hemorrhoidectomy using the standard Milligan-Morgan technique. Postoperatively, patients receive standardized analgesia and care, with systematic follow-up at 1 week, 2 weeks, 1 month, 3 months, and 6 months to evaluate pain scores, bleeding, wound healing, complication rates, return to normal activity, and symptom recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18 years or older.
- •Patients with symptomatic grade III or grade IV hemorrhoidal disease.
- •Combined internal and external hemorrhoidal disease requiring excisional hemorrhoidectomy.
- •Recurrent bleeding, prolapse, pain, mucous discharge, or hygiene difficulty despite conservative or office-based treatment.
排除标准
- •Patients younger than 18 years.
- •Grade I or grade II hemorrhoids suitable for conservative or office-based therapy.
- •Acute thrombosed external hemorrhoids requiring emergency management.
- •Associated anal fissure, fistula-in-ano, perianal abscess, or inflammatory bowel disease.
- •Suspected or confirmed colorectal malignancy[cite: 1].
- •History of previous anorectal surgery[cite: 1].
- •Bleeding diathesis, uncontrolled anticoagulant therapy, or severe coagulopathy[cite: 1].
研究组 & 干预措施
Conventional Ligation Hemorrhoidectomy Group
Patients undergoing conventional excisional hemorrhoidectomy using the Milligan-Morgan technique with suture ligation of the vascular pedicle.
干预措施: Conventional Milligan-Morgan hemorrhoidectomy (Procedure)
Sutureless Hemorrhoidectomy Group
Patients undergoing sutureless excisional hemorrhoidectomy using an energy-based vessel sealing device (LigaSure or Harmonic Scalpel) without conventional pedicle transfixion or suture ligation.
干预措施: Energy-based sutureless hemorrhoidectomy (Procedure)
结局指标
主要结局
Postoperative Pain Score
时间窗: Up to 6 months post-surgery
Assessed using the Visual Analogue Scale (VAS) scored from 0 (no pain) to 10 (worst imaginable pain) at fixed postoperative intervals.
Incidence of Postoperative Bleeding
时间窗: Up to 6 months post-surgery
Evaluation of early or delayed postoperative perianal bleeding requiring intervention or readmission.
次要结局
- Operative Time(Intraoperative (at time of surgery))
- Intraoperative Blood Loss(Intraoperative (at time of surgery))
- Total Postoperative Analgesic Requirement(Up to 6 months post-surgery)
- Time to Complete Wound Healing(Assessed at 1 week, 2 weeks, 1 month, 3 months, and 6 months)
- Length of Hospital Stay(From surgical admission up to discharge (average 1-2 days))
- Time to Return to Normal Activity(Up to 6 months post-surgery)
- Rate of Postoperative Complications and Recurrence(Up to 6 months post-surgery)
研究者
Keroless Mohareb Abdelmalak
Resident of General Surgery, Oncological and Laparoscopic Surgery
Sohag University