Laparoscopic Transabdominal Preperitoneal Surgical Repair of Inguinal Hernia Using Sutured Repair Versus Tacker Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Median and Range of Numeric Pain Rating Scale (NPRS) score [(median (range)]
研究概览
简要总结
Background: Mesh fixation is a critical step in laparoscopic Transabdominal Preperitoneal (TAPP) hernia repair because fixation is a significant step to prevent the hazard of mesh migration, but is supposed to be associated with a higher risk of acute and chronic pain compared with non-fixation. Fixation is more expensive than non-fixation.
Objective: To compare the efficiency of mesh fixation in laparoscopic TAPP surgical repair of inguinal hernia using sutured repair versus tacker use.
Patients and Methods: This prospective randomized comparative study was carried out on 60 patients who presented with a unilateral inguinal hernia and were assigned to laparoscopic TAPP hernia repair. Patients were randomly allocated into two equal groups (30 patients each); in group A, the mesh was fixed with a Titanium tacker, and in group B, the mesh was sutured and fixed with polypropylene 0.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 21 years
- •American Society of Anesthesiologists (ASA) physical status ≤ II
- •Patients with body mass index (BMI) of 25 to 35 kg/m²
- •Unilateral inguinal hernia
排除标准
- •Age < 21 years
- •ASA physical status > II
- •Patients with body mass index (BMI) > 35 kg/m²
- •Pregnant women
- •Bilateral inguinal hernia
- •Large inguinoscrotal hernia
- •Incarcerated hernia
- •Recurrent hernia
- •Strangulated hernia
- •Prostatic diseases
- •History of; Convulsions, Cerebrovascular accident, Previous neurological diseases
- •Dysrhythmia
- •Hypertension
- •Ischemic heart disease
- •Hyperthyroidism
- •Liver or Renal impairment
- •Alcohol or drug abuse
结局指标
主要结局
Median and Range of Numeric Pain Rating Scale (NPRS) score [(median (range)]
时间窗: 7 days after the end of the operation
NPRS measures the severity of postoperative pain, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (2h, 6h, 12h, 24h, 48h, 72h, and 7 days)
Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD)
时间窗: 7 days after the end of the operation
NPRS measures the severity of postoperative pain, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (2h, 6h, 12h, 24h, 48h, 72h, and 7 days)
次要结局
- Number of participants and Rate of Postoperative complications(1 year after the end of the operation)
- Mean and Standard deviation of Operative duration (minutes) (mean±SD)(2 minutes after the end of the operation)
- Mean and Standard deviation of Length of hospital stay (hours) (mean±SD)(24 hours after the end of the operation)
- Number of participants and Rate of Intraoperative complications(2 minutes after the end of the operation)