| CTRI Number |
CTRI/2024/08/072358 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the patient related outcomes in patient who undergo open method of surgical repair and patients who undergo laparoscopic surgical repair amongst those patients who are suffering from Inguinal Hernia |
|
Scientific Title of Study
|
To assess the patient related outcome measures following open and laparoscopic repair in cases of Inguinal hernia in a tertiary care centre in western Maharashtra- A randomised control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dheerendra Yadav |
| Designation |
Junior Resident |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of General Surgery
Armed Forces Medical College, Pune 40
Pune
MAHARASHTRA
411040
India |
| Phone |
9923817883 |
| Fax |
|
| Email |
dheerucms93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ameet Kumar |
| Designation |
HOD, GI Surgery Department |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of GI Surgery
Command Hospital Southern Command
Pune 40
Pune
MAHARASHTRA
411040
India |
| Phone |
9013818845 |
| Fax |
|
| Email |
ameetalpha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dheerendra Yadav |
| Designation |
Junior Resident |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of General Surgery
Armed Forces Medical College, Pune 40
Pune
MAHARASHTRA
411040
India |
| Phone |
9923817883 |
| Fax |
|
| Email |
dheerucms93@gmail.com |
|
|
Source of Monetary or Material Support
|
| Command Hospital(SC), Pune, Maharashtra, 411040
India |
|
|
Primary Sponsor
|
| Name |
Department of General Surgery |
| Address |
Command Hospital (SC) Pune, Maharashtra 411040, India |
| 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 Dheerendra Yadav |
Surgical Division, Command Hospital Pune |
Command Hospital Southern Command , Pune
Pune
MAHARASHTRA |
9923817883
dheerucms93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AFMC |
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 |
Laparoscopic Surgery |
Laparoscopic Inguinal hernia Repair(Lap TEP/Lap TAPP) |
| Comparator Agent |
Open Mesh Hernia Surgery |
Open mesh Hernioplasty |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All unilateral inguinal hernias |
|
| ExclusionCriteria |
| Details |
Patients with bilateral hernia
Unfit for Surgery
Chronic pain patients |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patient related outcome measures demonstrate better results in patients undergoing Laparoscopic repair for inguinal hernia as compared to open repair |
6hrs, 24 hrs, 36 hrs, 72 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain is less in laparoscopic repair as compared to open repair of inguinal hernia |
3months |
|
|
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)
|
31/08/2024 |
| 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)
|
Closed to Recruitment of Participants |
| 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
|
The study aims to assess the patient related outcome measures in patients undergoing open and laparoscopic repair in cases of inguinal hernia in a tertiary care centre in western Maharashtra. Both are established and proven methods of hernia repair. |