A study to evaluate the operative outcomes in tension-free open inguinal hernia hernioplasty using a sterilised mosquito net-mesh versus a polypropylene mesh.

Phase 2/3

Active, not recruiting

Conditions: Unilateral inguinal hernia, without obstruction or gangrene, (2) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene,

Registration Number: CTRI/2024/01/061320

Lead Sponsor: Department of General surgery, Sarojini Naidu Medical College, Agra

Brief Summary: 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.

â€¢ 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.

2. To estimate the efficacy of sterilized net mesh in inguinal hernia repair

3. 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: All

Target Recruitment: 300

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 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	To be assessed in a study period of 1 year, i.e. January 2024 to December 2024.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1): Sarojini Naidu Medical College
🇮🇳
Agra, UTTAR PRADESH, India
Sarojini Naidu Medical College
🇮🇳Agra, UTTAR PRADESH, India
Dr Juhi Singhal
Principal investigator
9760014708
juhisinghal75@gmail.com