Light weight mesh vs Heavy weight mesh in open inguinal hernioplasty, a prospective and comparative study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- To Compare the Outcome of Light Weight mesh Vs Heavy Weight Mesh.
研究概览
简要总结
There is a constant debate between usage of Light weight vs heavy weight mesh in Inguinal Hernia repair. More studies were done Concentrating on Laparoscopic repairs rather than Open repairs. Chronic pain rather than recurrence is considered as a Greater adverse Outcome.
Patient will be approached for participating in the study and will be explained the details regarding the same. An informed consent is taken once the patient agrees and then will be recruited into the study. He will be placed in either of two groups, namely Light weight mesh category or a Heavy weight mesh category which is entirely based upon the surgeon preference. After the procedure he will be monitored regarding factors like postoperative pain, infection seroma formation which will be mentioned in the outcome measures
Patients are followed up for Postoperative Complications like Infection, Seroma formation, Foreign body sensation, Groin Stiffness along with Recurrence and Chronic groin Pain. Pain Score Based on Visual analogue scale(VAS) recorded on a scale of 0 to 10 on Postoperative day 1, Postoperative day 2, 1st followup day, after 3months and after 6months. Patient data on Duration of Hospital stay and Duration to start Physical activity is noted. Patients are questioned on quality of life after surgery with a followup periodmof 6months
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with Inguinal Hernia who underwent Open Inguinal hernioplasty.
排除标准
- •Patients with recurrent Inguinal hernia repair 2) patients with previous surgeries in Inguinoscrotal region 3) patients who underwent Inguinal hernia repair without mesh 4) patient who underwent any other surgery concurrent with Inguinal Hernioplasty 5) Patients who want to get operated only in laparoscopic approach 6) All emergency Presentations 7) Patients less than 18yrs of age.
结局指标
主要结局
To Compare the Outcome of Light Weight mesh Vs Heavy Weight Mesh.
时间窗: at baseline
次要结局
- to Compare the PostOperative Pain, PostOperative Complications like Urinary Retention, Seroma Formation, Wound Infection, groin pain & Stiffness, Scrotal pain, To compare Chronic Inguinodynia, Inguinal stiffness, foreign body Sensation on followup & to compare recurrence on followup(3months)