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临床试验/NCT07520734
NCT07520734招募中不适用

Clinical Outcomes, Pain Scores, and Patient Satisfaction in Patients Undergoing Laser Hemorrhoidoplasty: A Prospective Observational Study

Sanliurfa Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Postoperative pain score

研究概览

简要总结

This single-center prospective observational study aims to evaluate clinical outcomes, postoperative pain scores, complications, and patient satisfaction in adults undergoing laser hemorrhoidoplasty for symptomatic internal hemorrhoidal disease. Additional objectives are to assess the relationship between hemorrhoid stage, dominant presenting symptoms, operative technical details, and postoperative outcomes. No study-specific intervention beyond routine clinical care and follow-up will be performed.

详细描述

Hemorrhoidal disease is a common benign anorectal condition that can significantly impair quality of life. Conventional excisional techniques may be associated with postoperative pain, bleeding, prolonged recovery, and lower patient satisfaction. Laser hemorrhoidoplasty is a minimally invasive technique based on coagulation and shrinkage of hemorrhoidal tissue without excision. This prospective observational study will be conducted at the General Surgery Clinic of Sanliurfa Education and Research Hospital. Adult patients with symptomatic internal hemorrhoidal disease who are scheduled to undergo laser hemorrhoidoplasty will be enrolled. Preoperative symptoms, hemorrhoid stage, and physical examination findings will be recorded. Intraoperative data will include laser wavelength, total delivered energy, number of hemorrhoidal packages treated, and any additional surgical procedures. Postoperative pain will be assessed at predefined time points using the Visual Analog Scale. Analgesic requirement and duration, length of hospital stay, time to return to daily activities, early complications within 30 days, late complications, symptom status, and recurrence at 6 months will be documented. The study is designed to clarify the clinical role of laser hemorrhoidoplasty and help define appropriate patient selection criteria.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years or older
  • Symptomatic internal hemorrhoidal disease
  • Scheduled to undergo laser hemorrhoidoplasty
  • Willingness to participate and provision of informed consent

排除标准

  • Grade IV hemorrhoidal disease
  • Acute thrombosed hemorrhoids
  • Additional anorectal pathology such as anal fissure, fistula, or perianal abscess
  • History of inflammatory bowel disease or colorectal malignancy
  • Previous major anal surgery'

研究组 & 干预措施

Patients undergoing laser hemorrhoidoplasty

Adults with symptomatic internal hemorrhoidal disease undergoing laser hemorrhoidoplasty.

干预措施: Laser Hemorrhoidoplasty (Procedure)

结局指标

主要结局

Postoperative pain score

时间窗: At 6 hours, 24 hours, and 1 week after surgery

Postoperative pain assessed using a 0 to 10 Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain; higher scores indicate worse pain.

次要结局

  • Duration of postoperative analgesic use(From the day of surgery through 30 days after surgery)
  • Length of hospital stay(From the day of surgery to hospital discharge, up to 7 days)
  • Incidence of predefined early postoperative complications(Within 30 days after surgery)
  • Time to return to daily activities(Up to 30 days after surgery)
  • Patient satisfaction(Up to 3 months after surgery)

研究者

发起方
Sanliurfa Education and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Vedat Kaplan

General Surgery Specialist

Sanliurfa Education and Research Hospital

研究点 (1)

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