A randomized control trial to evaluate the effectiveness of onlay and sublay mesh repair in the treatment of ventral hernia.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
研究概览
简要总结
After the clearance from the IRC and IEC, sampling of 80 patients for onlay mesh repair and sublay mesh repair attending op and IP service during the study period mentioned, fulfilling the inclusion and exclusion criteria already listed above will be recruited for the study, after obtaining informed consent .The nature, purpose, and the roles in the study will be explained in detailed, including the information that their non-participation in the study would not affect the quality of the treatment that they are to receive and that they are free exit the study at any time. After assuring that their response would remain confidential, an informed written consent for the same shall be obtained from the all participants .Patients will be subjected to clinical examination and evaluated for vitals and clinical signs. Investigations such complete blood count, urine routine and microscopy, urea, electrolytes,serum creatinine and liver function test will be done Patients will be randomized into two groups of 40 patients in each group. Onlay mesh repair and sublay mesh repair will be performed for both the groups by the same surgeon. In one group onlay mesh repair and in the other group sublay mesh repair will be performed .Duration of surgery intra operative complications, ease of use (surgeon perceived), post
operative complication, duration of post operative hospital stay evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Patients aged 18 to 75 years diagnosed with primary or incisional ventral hernia.
- •2.Fit for elective surgical repair using mesh.
- •3.Consent to participate in the study.
排除标准
- •1.Recurrent hernias.
- •2.Immunocompromised patients or on steroids.
- •Emergency hernia surgeries.
- •4.Known hypersensitivity to cyanoacrylate.
研究者
U Kavitha
Aarupadai Veedu Medical College
