| CTRI Number |
CTRI/2022/02/040413 [Registered on: 18/02/2022] Trial Registered Prospectively |
| Last Modified On: |
17/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Comparison between two mesh groups in open inguinal hernia repair |
|
Scientific Title of Study
|
Comparative study of polypropylene mesh versus polyester mesh in open inguinal hernia repair |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrTharun Ganapathy |
| Designation |
associate professor |
| Affiliation |
Srm Medical College Hospital and Research Centre |
| Address |
SRM Medical College Hospital and Research Centre
kattankulathur Department of general surgery
kattankulathur Kancheepuram TAMIL NADU 603203 India |
| Phone |
9840044437 |
| Fax |
|
| Email |
drtarunchitrambalam@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrTharun Ganapathy |
| Designation |
associate professor |
| Affiliation |
Srm Medical College Hospital and Research Centre |
| Address |
SRM Medical College Hospital and Research Centre
kattankulathur Department of general surgery
kattankulathur Kancheepuram TAMIL NADU 603203 India |
| Phone |
9840044437 |
| Fax |
|
| Email |
drtarunchitrambalam@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DrTharun Ganapathy |
| Designation |
associate professor |
| Affiliation |
Srm Medical College Hospital and Research Centre |
| Address |
SRM Medical College Hospital and Research Centre
kattankulathur Department of general surgery
kattankulathur Kancheepuram TAMIL NADU 603203 India |
| Phone |
9840044437 |
| Fax |
|
| Email |
drtarunchitrambalam@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Medical college hospital and research centre |
|
|
Primary Sponsor
|
| Name |
Dr Sundeep |
| Address |
4/26 bharathi street
west mambalam
chennai 600033 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| sundeep |
SRM Medical College hospital and research centre |
Department of general surgery
Room number 300
Third floor B block
kattankulathur Kancheepuram TAMIL NADU |
9790756554
sundeep.kumaran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital and Research centre Institutional Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
lichtenstein tension free repair |
Open inguinal hernioplasty- with placement of either one of two meshes studied after reducing the hernial contents and posterior all plication if applicable |
| Comparator Agent |
nil applicable |
nil applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of both sexes aged more than 18 years of age and giving valid written informed consent.
Patient with unilateral or bilateral inguinal hernia
|
|
| ExclusionCriteria |
| Details |
Complicated hernia
Co-morbidities
Recurrent inguinal hernia
COPD/BPH or any other associated illness causing increased intra-abdominal pressure
Patients not willing for the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the post operative pain between polypropylene mesh and polyester mesh |
Post operative pain is assessed 24 hours, 48 hours, 3 days, 7 days, 2 weeks, 4 weeks , 3 months using visual analogue scale |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess the complication rate among both mesh group like seroma, infection |
to assess the complication rate among both mesh group like seroma, infection at 24 hours, 48 hours, 1 week, 3 weeks, 3 months |
|
|
Target Sample Size
|
Total Sample Size="144" Sample Size from India="144"
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)
|
24/02/2022 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
ABSTRACT BACKGROUND: Inguinal hernia is one of the most common surgical problems presenting to the surgical out patient department. Surgery being main treatment for hernia, surgical techniques of inguinal hernia has undergone a great development over a period of centuries and decades. Litchenstein’s tension free hernia repair have revolutionized the procedure and is the one of the first surgeries learnt by a surgery resident. Although the recurrence rates in hernia surgery have drastically been brought down by the placement of mesh, post operative pain still remain troublesome in hernia repair. Polyester is an softer pliable material offering the benefit of less post operative pain and improved quality of life than the routinely used polypropylene mesh METHODS: A prospective single blinded randomized control trial involving 144 patients who underwent Lichtenstein tension free repair were divided equally in 2 groups Group A - polypropylene mesh(n=72) and Group B polyester mesh (n=72). All the patients were operated by a single surgeon to maintain uniformity. Postoperatively, pain was assessed and compared using Visual Analogue Score (VAS) at 12 hours, 24 hours and 48 hours in the hospital and at 1 week, 1 month, and 3 months on outpatient basis. Additional analgesic requirements were recorded and postoperative complications were noted and compared. CONCLUSION: The usage of polyester mesh in open inguinal hernia repair was comparable and superior with that of polypropylene mesh in terms of less early and intermediate post operative pain, decreased additional analgesic requirements and reduced duration of stay in the hospital. |