Randomized Controlled Trial Comparing the Desarda Tissue Technique With the Lichtenstein Technique in Primary Inguinal Hernia Repair
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 478
- 试验地点
- 1
- 主要终点
- Rate of Participants with Post-surgery Complications
研究概览
简要总结
This study aims to evaluate whether a surgical technique (Desarda) is superior to the commonly used surgical technique (Lichtenstein) in inguinal hernia repair concerning the occurrence of postoperative complications. The Lichtenstein technique involves the use of a mesh, while the Desarda technique does not.
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, Investigator, Outcomes Assessor)
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
- •Diagnosed with primary inguinal hernia.
- •Body mass index below 31
- •Indication for inguinal hernia repair via anterior approach, either as outpatient surgery (CMA) or elective admission.
- •Legal capacity to provide informed consent.
排除标准
- •Patients with a weak, thin, or divided external oblique aponeurosis.
- •Participants diagnosed with any of the following conditions:
- •Ongoing oncological disease
- •Cirrhotic patients classified as Child B or higher
- •Women who have previously undergone a cesarean section
- •Cognitive or affective conditions that limit the ability to cooperate with the study procedures
研究组 & 干预措施
Lichtenstein Technique
Patients asigned to this arm will be treated with Lichtenstein Technique
干预措施: Lichtenstein (Procedure)
Desarda Technique
Patients asigned to this arm will be treated with Desarda Technique
干预措施: Desarda (Procedure)
结局指标
主要结局
Rate of Participants with Post-surgery Complications
时间窗: 3 months
Any of the following complications: ● Sensation of a foreign body that persists beyond 3 months after surgery, self-reported by the participant ● Seroma within the first 30 days after surgery, verified through physical examination by a surgeon ● Hematoma within the first 30 days after surgery, verified through physical examination by a surgeon ● Infection at the surgical site within the first 30 days after surgery, verified by a surgeon ● Severe postoperative pain (7 or higher on the visual analog scale \[VAS\]) within the first 30 days after surgery, self-reported by the participant ● Chronic postoperative pain (persisting more than three months after surgery), self-reported by the participant ● Persistent loss of skin sensitivity beyond 30 days after surgery, self-reported by the participant ● Limitation of normal activities at home, outside the home, or at work beyond 3 months after surgery, self-reported by the participant
次要结局
未报告次要终点