| CTRI Number |
CTRI/2024/01/061320 [Registered on: 10/01/2024] Trial Registered Prospectively |
| Last Modified On: |
12/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to evaluate the operative outcomes in tension-free open inguinal hernia hernioplasty using a sterilised mosquito net-mesh versus a polypropylene mesh. |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kshitij Srivastava |
| Designation |
Junior Resident |
| Affiliation |
Sarojini Naidu Medical College, Agra |
| Address |
Department of General surgery, 2nd floor, New Surgery Building, SN Medical College, Agra
Agra
UTTAR PRADESH
282003
India |
| Phone |
7000070562 |
| Fax |
|
| Email |
dr04kshitij@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Juhi Singhal |
| Designation |
Professor |
| Affiliation |
Sarojini Naidu Medical College, Agra |
| Address |
Department of General surgery, 2nd floor, New Surgery Building, Sarojini Naidu Medical College, Agra
Agra
UTTAR PRADESH
282003
India |
| Phone |
9760014708 |
| Fax |
|
| Email |
juhisinghal75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Juhi Singhal |
| Designation |
Professor |
| Affiliation |
Sarojini Naidu Medical College, Agra |
| Address |
Department of General surgery, 2nd floor, New Surgery Building, Sarojini Naidu Medical College, Agra
Agra
UTTAR PRADESH
282003
India |
| Phone |
9760014708 |
| Fax |
|
| Email |
juhisinghal75@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General surgery, Sarojini Naidu Medical College, Agra, Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Department of General surgery, Sarojini Naidu Medical College, Agra |
| Address |
Sarojini Naidu Medical College, Agra, Uttar Pradesh |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Juhi Singhal |
Sarojini Naidu Medical College |
Department of General surgery, 2nd Floor, New Surgery Building, Sarojini Naidu Medical College, Moti Katra, Mantola, Agra, Uttar Pradesh 282003
Agra
UTTAR PRADESH |
9760014708
juhisinghal75@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, SN Medical College Agra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (2) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Sterilized mosquito net mesh in Open Inguinal Hernioplasty |
A sterilised mosquito net-mesh will be used for Tension-Free Open Inguinal Hernia
Meshplasty instead of a polypropylene synthetic mesh and results will be compared. The duration of the procedure is expected to be of 1 hour to 1.5 hours. |
| Comparator Agent |
Tension-Free Open Inguinal Hernia
Meshplasty Using a synthetic polypropylene mesh |
Tension free open inguinal hernioplasty will be performed using a synthetic polypropylene mesh of size 7.5cm ×15cm and results will be compared to that of the same above-mentioned procedure with sterilised mosquito net-mesh in place of synthetic polypropylene mesh. The duration of such procedure is expected to be 1 hour to 1.5 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
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
|
To be assessed in a study period of 1 year, i.e. January 2024 to December 2024. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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. |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/01/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - Data will be available by email at dr04kshitij@gmail.com
- For how long will this data be available start date provided 12-05-2024 and end date provided 12-05-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
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. • 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.
|