| CTRI Number |
CTRI/2024/10/074854 [Registered on: 07/10/2024] Trial Registered Prospectively |
| Last Modified On: |
30/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessment of post operative pain after mesh fixation with two different suture materials in patients operated for inguinal hernia repair. |
|
Scientific Title of Study
|
A randomised control trial of mesh fixation with polypropylene sutures (prolene) versus polyglactin sutures (vicryl) sutures in assessing inguinodynia in open inguinal hernia repair. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Shraddha Gajbhiye |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of General Surgery,
Jawaharlal Nehru Medical College
Sawangi (Meghe), Wardha Sawangi Meghe
Wardha
Maharashtra- 442001 Wardha MAHARASHTRA 442001 India |
| Phone |
7875372398 |
| Fax |
|
| Email |
gajbhiyeshraddha2@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Imran Ali Khan |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of General Surgery
Jawaharlal Nehru Medical College
Sawangi (Meghe)
Wardha
Wardha MAHARASHTRA 442001 India |
| Phone |
7875372398 |
| Fax |
|
| Email |
drimk@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr. Imran Ali Khan |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of General Surgery
Jawaharlal Nehru Medical College
Sawangi (Meghe)
Wardha
Wardha MAHARASHTRA 442001 India |
| Phone |
7875372398 |
| Fax |
|
| Email |
drimk@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery
Jawaharlal Nehru Medical College, Sawangi, Wardha-442001 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College |
| Address |
Department of General Surgery
Jawaharlal Nehru Medical College
Sawangi, Wardha- 442001 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Shraddha Gajbhiye |
Department of General Surgery
Jawaharlal Nehru Medical College
Sawangi Meghe, Wardha
Maharashtra- 442001 |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shraddha Gajbhiye |
Jawaharlal Nehru Medical College |
Department of General Surgery
Jawaharlal Nehru Medical College
Sawangi Meghe
Wardha Wardha MAHARASHTRA |
7875372398
gajbhiyeshraddha2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research (Deemed to be University) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dr. Shraddha Gajbhiye |
To assess and compare post operative inguinodynia of prolene versus vicryl mesh fixation in open inguinal hernia repair |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
Inclusion Criteria:
1. Primary inguinal hernia
2. Uncomplicated hernia
3. Age range of 18 to 70 years
4. Unilateral or bilateral inguinal hernia
5. Nerve identification
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria
Irreducible hernias, patients with bleeding disorders, patients on anticoagulant treatment, pregnancy, patients needing emergency repair, HIV and HbsAg positive patients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Based on the findings of the present study it may be concluded that, using polyglactin suture material to fix mesh is a safe, simple as well as an effective alternative to the conventional usage of polypropylene sutures for fixing the mesh in Lichtenstein hernia repair. The post- operative pain on day 1 and day 3 is similar with both vicryl and prolene sutures but on the day 7 and after 3 months it is significantly less. |
Post operative day 1, 3, 7 and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hence our study helps use to understand the benefits of using polyglactin sutures & also enables us to recommend its application to fix the mesh in Lichtenstien’s hernioplasty. So, routine usage of polyglactin (vicryl) sutures for mesh fixation in a Lichtenstien’s hernioplasty is safe & simple & thus a reasonable option.
|
Post operative day 1,3,7 & 3 months |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
11/10/2025 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Inguinal hernia, the most frequently occurring type of hernia globally, Chronic groin pain could be related to nerve mangling while operating. Mesh repair can lead to an inflammatory reaction over a period of time, though it still needs ground work to find out exact cause of pain. So this study aims to compare the effectiveness of polyglactin versus prolene sutures in reducing the post-operative pain in inguinal hernia repair. Chronic pain in the groin is a notable problem post Lichtenstien’s repair, even though the pain is usually mild, studies have revealed that irrespective of the severity, chronic pain may considerably hamper day to day activity. Chronic pain is the principle issue linked with the Lichtenstein technique with a conclusive rate between 15% and 40%. Routine usage of absorbable sutures to fix mesh in Lichtenstien’s repair have resulted in reduce post- operative chronic pain, yet controversies persist. So we took up this study to appraise post-operative groin pain in the patients where polyglactin sutures were used to fix the mesh (group A) versus polypropylene sutures in doing the same (group B) in Lichtenstein inguinal hernia repair. There have been many theories regarding the causes for the groin pain and one plausible theory is pain after surgery persists for a long period due to is inflammatory changes, fibrosis, subsequently entrapment of nerve, induced either by mesh or suture material, that’s in proximity of ilioinguinal nerve. Apart from this untimely mangling to nerve at the time of dissection may contribute as well to this. Vicryl (polyglactin) is a synthetic, absorbable, braided suture which can sustain its tensile strength for nearly 3 to 4 weeks in tissues. It’s entirely absorbed by hydrolysis within 60 days. |