| CTRI Number |
CTRI/2021/09/036264 [Registered on: 06/09/2021] Trial Registered Prospectively |
| Last Modified On: |
04/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two types of mesh fixation technique in open inguinal hernia surgery |
|
Scientific Title of Study
|
Comparison of two point fixation versus conventional fixation of polypropylene mesh in patients undergoing Lichtenstein repair for inguinal hernia: a pilot study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vinayaka HJ |
| Designation |
Postgraduate resident |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Room 416, D1 Block, AIIMS, Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9482046997 |
| Fax |
|
| Email |
hjvinayaka@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Debajyoti Mohanty |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Room 416, D1 Block, AIIMS, Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
8518881737 |
| Fax |
|
| Email |
debajyotimohanty@aiimsraipur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Debajyoti Mohanty |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Room 416, D1 Block, AIIMS, Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
8518881737 |
| Fax |
|
| Email |
debajyotimohanty@aiimsraipur.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Raipur |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Raipur |
| Address |
Tatibandh, GE Road, Raipur, CG, 492099 |
| 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 Debajyoti Mohanty |
All India Institute of Medical Sciences, Raipur |
Department of General Surgery
Raipur
CHHATTISGARH |
8518881737
debajyotimohanty@aiimsraipur.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, AIIMS Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional fixation of polypropylene mesh |
The polypropylene mesh will be fixed with a 3-0 polypropylene suture to the inguinal ligament, conjoint tendon and the pubic tubercle as described by standard Lichtenstein technique. |
| Intervention |
Two point fixation of polypropylene mesh |
The polypropylene mesh will be fixed with a 3-0 polypropylene suture at two points, The first point of fixation is just beyond the pubic tubercle and second point is at the internal ring involving the both the slit ends of the mesh |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients > 18 years with uncomplicated primary inguinal hernia |
|
| ExclusionCriteria |
| Details |
1. ASA grade III and IV patients
2. Emergency hernioplasty
3. Recurrent inguinal hernia
4. Hernioplasty combined with orchiectomy or any additional procedure
5. Patients on immunosuppressive agents, steroid therapy, antipsychotic drugs
6. History of connective tissue disorder (eg: Rheumatoid arthritis, Scleroderma, Sjogren syndrome, Lupus erythematosus )
7. Patients having allergy to Paracetamol
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of postoperative groin discomfort |
To be measured at 06 hours, 24 hours. 07 days, and 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of surgery |
to be measured in minutes starting from the time of skin incision to last skin approximation suture |
| The total number of doses of analgesia required in postoperative period |
From the postoperative recovery room upto the time of discharge from hospital |
| The length of postoperative hospital stay |
To be measured in hours starting from the time of commencement of surgery up to the time of discharge |
| The incidence of chronic groin discomfort |
To be measured at 03 months using visual analogue score |
| Operational cost saving with two point mesh fixation technique |
to be calculated in INR depending upon the usage of suture materials for each intervention |
| Local surgical site complications |
To be evaluated clinically at the time of discharge, at 07 days, 30 days and 90 days |
| The quality of life and satisfaction score of the patients |
To be evaluated at 03 months using Q-LES-Q-SF questionnaire and ECOG score |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "72"
Final Enrollment numbers achieved (India)="72" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/09/2021 |
| Date of Study Completion (India) |
31/01/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- 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 - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [debajyotimohanty@aiimsraipur.edu.in].
- For how long will this data be available start date provided 01-12-2021 and end date provided 31-01-2022?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
This randomised trial intends to evaluate the reduced rate of recurrence as well as improvement in the postoperative pain scores with of polypropylene mesh fixation at two ends of the inguinal canal (pubic tubercle and internal ring) to cover the posterior inguinal wall defect than conventional mesh fixation of Lichtenstein repair in adult patients with uncomplicated inguinal hernia. This study will recruit 45 patients in each intervention arm and follow them up for a period of 03 months following surgery for evaluation of the outcome measures. The postoperative groin discomfort will be considered the primary outcome measure in both the groups and duration of surgery, postoperative analgesia requirement, cost to the patient, chronic groin pain, and patient satisfaction will be evaluated as secondary outcome measures. |