Comparative study of polypropylene mesh versus polyester mesh in open inguinal hernia repair
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- To assess the post operative pain between polypropylene mesh and polyester mesh
研究概览
简要总结
ABSTRACT
BACKGROUND:
Inguinal hernia is one of the most common surgical problems presenting to the surgical out patient department. Surgery being main treatment for hernia, surgical techniques of inguinal hernia has undergone a great development over a period of centuries and decades. Litchenstein’s tension free hernia repair have revolutionized the procedure and is the one of the first surgeries learnt by a surgery resident**.** Although the recurrence rates in hernia surgery have drastically been brought downby the placement of mesh, post operative pain still remain troublesome in hernia repair. Polyester is an softer pliable material offering the benefit of less post operative pain and improved quality of life than the routinely used polypropylene mesh
METHODS:
A prospective single blinded randomized control trial involving 144 patients who underwent Lichtenstein tension free repair were divided equally in 2 groups Group A - polypropylene mesh(n=72) and Group B polyester mesh (n=72). All the patients were operated by a single surgeon to maintain uniformity. Postoperatively, pain was assessed and compared using Visual Analogue Score (VAS) at 12 hours, 24 hours and 48 hours in the hospital and at 1 week, 1 month, and 3 months on outpatient basis. Additional analgesic requirements were recorded and postoperative complications were noted and compared.
CONCLUSION:
The usage of polyester mesh in open inguinal hernia repair was comparable and superior with that of polypropylene mesh in terms of less early and intermediate post operative pain, decreased additional analgesic requirements and reduced duration of stay in the hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of both sexes aged more than 18 years of age and giving valid written informed consent.
- •Patient with unilateral or bilateral inguinal hernia.
排除标准
- •Complicated hernia Co-morbidities Recurrent inguinal hernia COPD/BPH or any other associated illness causing increased intra-abdominal pressure Patients not willing for the study.
结局指标
主要结局
To assess the post operative pain between polypropylene mesh and polyester mesh
时间窗: Post operative pain is assessed 24 hours, 48 hours, 3 days, 7 days, 2 weeks, 4 weeks , 3 months using visual analogue scale
次要结局
- to assess the complication rate among both mesh group like seroma, infection(to assess the complication rate among both mesh group like seroma, infection at 24 hours, 48 hours, 1 week, 3 weeks, 3 months)