| CTRI Number |
CTRI/2019/09/021094 [Registered on: 06/09/2019] Trial Registered Prospectively |
| Last Modified On: |
05/09/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
outcomes of light weight mesh in inguinal hernia surgery |
|
Scientific Title of Study
|
Efficacy of light weight mesh repair for uncomplicated inguinal hernia-A randomized clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Thanigai sakthi vadivel |
| Designation |
Principal investigator |
| Affiliation |
Pondicherry institute of medical sciences. |
| Address |
PG Resident,Pondicherry Institute Of Medical sciences,Department of General surgery,Ganapathichettikulam,Pondicherry-605014
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9487366539 |
| Fax |
|
| Email |
Thanigaisakthivadivel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Authy |
| Designation |
Guide |
| Affiliation |
Pondicherry institute of medical sciences. |
| Address |
Professor and Head of Department of General Surgery,Pondicherry Institute Of Medical sciences,Department of General surgery,Ganapathichettikulam,Pondicherry-605014
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9444020801 |
| Fax |
|
| Email |
dr.authy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrThanigai sakthi vadivel |
| Designation |
Principal investigator |
| Affiliation |
Pondicherry institute of medical sciences |
| Address |
PG Resident,Pondicherry Institute Of Medical sciences,Department of General surgery,Ganapathichettikulam,Pondicherry-605014
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9487366539 |
| Fax |
|
| Email |
thanigaisakthivadivel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pondicherry Institute Of Medical sciences,Ganapathichettikulam,Pondicherry-605014 |
|
|
Primary Sponsor
|
| Name |
DrThanigai sakthi vadivel |
| Address |
Junior resident Department of General Surgery Pondicherry institute of medical sciences puducherry |
| Type of Sponsor |
Other [Principal investigator ] |
|
|
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 |
| DrThanigai sakthi vadivel |
Pondicherry institute of medical sciences |
Pondicherry institute of medical sciences,Department of General surgery,kalathumettupathai,Ganapathichettikulam,village no 20, kalapet,puducherry 605014
Pondicherry
PONDICHERRY |
9487366539
Thanigaisakthivadivel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIMS INSTITUTE ETHICS COMITTEE,Registered with CDSCO- Reg no.ECR/400/lnst/Py/2013,Pondicherry institute of medical sciences,kalapet,puducherry 605014 |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Heavy weight mesh used in inguinal hernia surgery and thier post operative outcomes studied. |
postoperatively patient followed up from day 3,1 week,1 month to assess the postoperative pain,Surgical site infection,seroma,hematoma |
| Intervention |
Light weight mesh used in inguinal hernia surgery and their postoperative outcomes studied. |
Postoperatively patient followed up from day 3,1 week,1month to assess the postoperative pain ,surgical site infection,seroma,hematoma. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
Patients willing to participate in the study.
All patients of age 18 yrs to 80 yrs with uncomplicated inguinal hernia |
|
| ExclusionCriteria |
| Details |
patients with irreducible inguinal hernia.
Recurrent hernia.
Strangulated hernia.
Benign prostatic hyperplasia.
Stricture urethra.
Patient refusal to participate in this study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Light weight mesh is better than heavy weight mesh in terms of postoperative pain,less surgical site infection. |
After surgery patients were followed up from postoperative day 3,1 week,1 month to assess for postoperative pain and SSI. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
30/09/2019 |
| 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="2"
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)?
|
|
Brief Summary
|
Inguinal hernias are the most common operative procedure performed by general surgeons, and tension free mesh technique have revolutionized the procedure.Decreased,chronic postoperative pain has become recognized more widely.New mesh products has been introduced now available.Which are considered to be better than conventional polypropylene mesh in terms of postoperative pain and infection rates.
Usage of prosthetic materials decreased the frequency of hernia recurrence,although the chronic pain and surgical site infection will considerably affect the patients quality of life.The pain may be caused by damage to the inguinal nerves, but the surgical site infection is due to the foreign body reaction against the mesh which results in inflammatory response and scar tissue formation. Now a days lightweight meshes are used instead of heavyweight polypropylene mesh.Low mass decreased content of foreign body and large pores characteristic of light weight mesh.So light weight mesh decrease the postoperative pain and decreased tissue reaction. |