| CTRI Number |
CTRI/2019/12/022498 [Registered on: 23/12/2019] Trial Registered Prospectively |
| Last Modified On: |
18/12/2019 |
| 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
|
Comparision of two different meshes in Hernia repair surgery |
|
Scientific Title of Study
|
Comparison of polypropylene versus polyester mesh in the Lichtenstein hernia repair with respect to chronic pain and inflammatory changes |
| Trial Acronym |
PROESTER |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajaypandian |
| Designation |
MS General Surgery (First year resident) |
| Affiliation |
PIMS |
| Address |
MS General Surgery (First year resident)
PIMS, Kalathumettupathai, Ganapathichettikulam, Village No.20, Kalapet, Puducherry, 605014
Pondicherry PONDICHERRY 605014 India |
| Phone |
8825520836 |
| Fax |
|
| Email |
srimugilmecse@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sampath Kumar |
| Designation |
Professor |
| Affiliation |
PIMS |
| Address |
Professor
Department of
General Surgery, Pondicherry Institute of medical sciences,Kalathumettupathai, Ganapathichettikulam, Village No.20, Kalapet, Puducherry, 605014
Pondicherry PONDICHERRY 605014 India |
| Phone |
9486267863 |
| Fax |
|
| Email |
skdrsampathkumar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ajaypandian |
| Designation |
MS General Surgery (First year Resident) |
| Affiliation |
PIMS |
| Address |
First year resident,
MS General Surgery,
Pondicherry Institute of medical sciences.Kalathumettupathai, Ganapathichettikulam, Village No.20, Kalapet, Puducherry, 605014
Pondicherry PONDICHERRY 605014 India |
| Phone |
8825520836 |
| Fax |
|
| Email |
srimugilmecse@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pondicherry Institute of medical sciences, kalathumettupathai, Ganapathichettikulam, Village no
20, kalapet, puducherry, 605014 |
|
|
Primary Sponsor
|
| Name |
Dr Ajaypandian |
| Address |
Junior resident Department of General Surgery Pondicherry
Institute Of Medical Sciences Puducherry |
| Type of Sponsor |
Other [Dr Ajaypandian] |
|
|
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 Ajaypandian |
PONDICHERRY INSTITUTE OF MEDICAL SCIENCES |
Address :
Kalathumettupathai,
Ganapathichettikulam,
Village No.20, Kalapet,
Puducherry, 605014
Pondicherry
PONDICHERRY Pondicherry PONDICHERRY |
8825520836
srimugilmecse@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIMS INSTITUTE ETHICS COMMITTEE(IEC), Registered with CDSCO- Reg No ECR/400/Inst/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 |
| Intervention |
To assess the postoperative pain following Lichtenstein inguinal hernioplasty using polyester mesh |
To assess the postoperative pain following Lichtenstein inguinal hernioplasty using polyester mesh |
| Comparator Agent |
To assess the postoperative pain following Lichtenstein inguinal hernioplasty using polypropylene mesh |
To assess the postoperative pain following Lichtenstein inguinal hernioplasty using polypropylene mesh |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All patients of age above 18 years with unilateral inguinal hernia presenting to PIMS undergoing surgery, willing to participate in this study |
|
| ExclusionCriteria |
| Details |
1.Patients with strangulated hernia,
2.Recurrent hernia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the postoperative pain following Lichtenstein inguinal hernioplasty using polyester vs. polypropylene mesh |
Post operatively after 1 week and after 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Assessment of inflammatory markers like [hsCRP, IL 6] in pre-op and postop at 12 hours
2.To document the duration of operative time, duration of hospital stay.
3.Assessment of surgical site infections, seroma and hematoma formation |
Post operative assessment |
|
|
Target Sample Size
|
Total Sample Size="94" Sample Size from India="94"
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)
|
30/12/2019 |
| 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="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)?
|
|
Brief Summary
|
Inguinal hernias are the most common operative procedures performed by general surgeons. Various procedures described to improve outcome in terms of decrease chronic pain and recurrence. Lichtenstein hernia repair showed a significant reduction in recurrence and also chronic pain. Usage of lightweight mesh materials like polyester is found to reduce inguinal hernia pain as compared to polypropylene mesh and improve quality of life. Prosthetic materials induce an inflammatory response characterized by an increased level of IL-6 and hsCRP.Chronic pain is that pain which persists at the surgical site and nearby surrounding tissues 3 months after surgery. Despite adequate research chronic postoperative pain continues to be a significant problem in hernioplasty. Polyester mesh has a higher degree of connective tissue integration, it has less mesh contraction, less fibrous encapsulation and less stiffness around the mesh. Prosthetic materials induce an inflammatory response characterized by an increased level of IL-6 and hsCRP, however, there is no significant difference between preoperative level, 12 hr, 48hr, and 2weeks. The main reasons hypothesized for chronic groin pain are per-operative nerve damage, post-operative fibrosis, or mesh-related fibrosis. They have been classified as either neuropathic or non-neuropathic pain. The three nerves potentially involved are the Ilioinguinal Nerve (IIN), Iliohypogastric Nerve (IHN) and genital branch of the Genitofemoral Nerve (GFN). These nerves can be damaged either by trauma during dissection or retraction of tissues, or nerve entrapment from post-operative fibrosis, mesh-related fibrosis or sutures used to fix the mesh. Non-neuropathic causes are excessive scar formation resulting from prosthetic mesh reaction, the periosteal reaction from sutures or staples inserted into the pubic tubercle or due to rolled-up bulky mesh leading to mechanical pressure. Hereby we are conducting a study to compare the efficacy between polypropylene mesh and polyester mesh in terms of pain, inflammatory changes |