A Multi-Centre, Prospective Observation Real- World Evidence study Comparing Mesh Fixation using Glue to Mesh fixation using tackers in patients undergoing Laparoscopic/Robotic Inguinal Hernia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 2
研究概览
简要总结
Laparoscopic/robotic inguinal hernia repair has become a widely accepted surgical approach due to its advantages over open repair including reduced postoperative pain, faster recovery and better cosmetic outcomes A critical aspect of this procedure is mesh fixation which plays a key role in preventing recurrence but may also contribute to complications such as chronic postoperative pain Traditionally mechanical fixation using tackers has been the most common method however it is associated with tissue trauma neurovascular injury and an increased risk of chronic pain.
In recent years atraumatic mesh fixation with tissue adhesive has increasingly become the method of choice It is the recommended mesh fixation method by the International Hernia Society Guidelines for groin hernia management It offers a less invasive approach that may reduce nerve damage and tissue irritation with favorable biological properties including biodegradability hemostatic capability and strong tissue adhesion have the potential to enhance healing and minimize postoperative discomfort However despite its theoretical advantages there is lack of comprehensive evidence from India which directly compares the clinical outcomes of adhesive glue versus traditional mechanical fixation methods in laparoscopic or robotic inguinal hernia repair
This study aims to address this gap by comparing clinical outcomes including postoperative pain, complications and recurrence rates, between patients undergoing mesh fixation with n butyl 2 cyano acrylate glue and those treated with mechanical tackers during laparoscopic or robotic inguinal hernia repair
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Adults greater than 18 years old Patients diagnosed with unilateral or bilateral uncomplicated inguinal hernia less than 3 cm Patients requiring laparoscopic or robotic inguinal hernia repair with mesh fixation using glue or tackers Patients who consent to participate in the study and adhere to the follow up schedule.
排除标准
- •Patients with recurrent hernias Patients with irreducible hernia Patients with contraindications to laparoscopic/robotic procedures Patients with a history of glue or tacker hypersensitivity Patients with other significant comorbidities (example uncontrolled diabetes active infection) that may affect surgical outcomes Patients unwilling or unable to provide informed consent.
研究者
Dr Vivek Bindal
Max Super Speciality Hospital Vaishali(A unit of Crosslay Remedies Limited)
