A study to Evaluate the operative outcomes in tension-free open inguinal hernia meshplasty using a sterilised mosquito net versus polypropylene mesh. A prospective hospital based randomised controlled trial.
试验速览
- 阶段
- 2/3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- 1.To assess the complications of a sterilized mosquito net mesh versus polypropylene synthetic mesh in-situ in terms of: Hematoma, Post-op Pain, Infection and Recurrence, etc.
研究概览
简要总结
Inguinal hernia repair is one of the most frequently performed procedures worldwide, but
raises specific problems in developing countries . In developing country with limited
resources, a mesh is used in less than 5% of patients , mainly because these expensive
devices (between 1000 and 5000 INR ) are neither affordable nor available.
The cost of importing a commercial synthetic mesh to low-income countries is commonly
reported to be approximately INR 1000-5000. This is in stark contrast to mosquito net mesh,
which costs consistently less than INR 10-20 for the net in bulk purchase or INR 150-200 per mesh. Following this,
the mesh must be sterilized and packaged. Sterilization is most commonly carried out using
an autoclave, which is cost-effective and used widely throughout India. However we will ETO (ethylene
oxide) sterilise the cut pieces. Even taking into consideration the cost of local sterilization
and packing, mosquito net mesh remains considerably cheaper than a commercial
synthetic mesh.
AIM AND OBJECTIVES
Aim- The aim of this study is comparison of feasibility, efficacy and cost of using sterilized
mosquito net mesh in Open inguinal hernia repair versus synthetic Polypropylene mesh.
• Objectives:-
1.To assess the complications of a sterilized mosquito net mesh versus polypropylene synthetic mesh in-situ in terms of: Hematoma, Post-op Pain, Infection and Recurrence, etc.
-
To estimate the efficacy of sterilized net mesh in inguinal hernia repair
-
To compare the feasibility and outcome of a sterilized mosquito net mesh versus a
polypropylene net mesh in inguinal hernia repair.
Place of work : Department of General Surgery, S.N. Medical College, Agra
Study Design : Prospective hospital based randomised control trial.
Duration of study : The study is scheduled to be completed in a period of 12 months or 1 year from
January 2024 to December 2024.
Study population : All patients 18 years and above requiring open Hernioplasty admitted in Sarojini Naidu Medical
College, Agra from 8th January 2024 to 31st December 2024 will be
eligible for the study.
Consent will be taken for participation in the study.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Patients aged 18 years and above both male and female 2 Patients having Unilateral bilateral inguinal hernias 3 Patients who give written and informed consent for participation.
排除标准
- •1 Patients having recurrent hernias 2 Patients with hernias other than inguinal hernias 3 Patients with obstructed or strangulated inguinal hernias 4 Patients with other comorbidities like uncontrolled diabetes or uncontrolled hypertension which may interfere with the post operative results 5 Patients undergoing laparoscopic hernia repair surgery as laparoscopic procedures are costly and time consuming.
结局指标
主要结局
1.To assess the complications of a sterilized mosquito net mesh versus polypropylene synthetic mesh in-situ in terms of: Hematoma, Post-op Pain, Infection and Recurrence, etc.
时间窗: To be assessed in a study period of 1 year, i.e. January 2024 to December 2024.
2.To estimate the efficacy of sterilized net mesh in inguinal hernia repair
时间窗: To be assessed in a study period of 1 year, i.e. January 2024 to December 2024.
次要结局
- To compare the feasibility and outcome of a sterilized mosquito net mesh versus a polypropylene net mesh in inguinal hernia repair.(To be assessed in a study period of 1 year, i.e. January 2024 to December 2024.)