| CTRI Number |
CTRI/2025/04/085911 [Registered on: 29/04/2025] Trial Registered Prospectively |
| Last Modified On: |
26/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparing pain after surgery in patients undergoing hernia operation using two different techniques |
|
Scientific Title of Study
|
Comparing sutures with tackers (ST) versus tackers alone [Double crown technique (DC)] for mesh fixation in reducing post-operative pain in patients undergoing laparoscopic ventral hernia repair (LVHR)- A double blinded randomized 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 |
Karavadi Anuradha |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal institute of postgraduate medical sciences and research institute |
| Address |
Jipmer Campus Rd, Jipmer Campus,
Dhanvantri Nagar
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8897444955 |
| Fax |
|
| Email |
karavadianuradha98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. suresh kumar |
| Designation |
professor and unit chief |
| Affiliation |
Jawaharlal institute of postgraduate medical sciences and research institute |
| Address |
Jipmer Campus Rd, Jipmer Campus,
Dhanvantri Nagar
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8897444955 |
| Fax |
|
| Email |
drsureshkumar08@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Karavadi Anuradha |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal institute of postgraduate medical sciences and research institute |
| Address |
Jipmer Campus Rd, Jipmer Campus,
Dhanvantri Nagar
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8897444955 |
| Fax |
|
| Email |
karavadianuradha98@gmail.com |
|
|
Source of Monetary or Material Support
|
| JIPMER, dharvantrhri nagar, jipmer campus road, pondicherry, 605006 |
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
Dhanvantri nagar, Jipmer campus road, JIPMER, pondicherry 605006 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Karavadi Anuradha |
JIPMER |
department of surgery, dhanvantri nagar, JIPMER campus road, pondicherry,
Pondicherry
PONDICHERRY |
8897444977
karavadianuradha98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER INSTITUTIONAL ETHICS COMMITTEE |
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 |
sutures |
mesh fixation using sutures in laparoscopic hernia repair, duration: takes 120mins |
| Intervention |
tackers with sutures |
mesh fixation with tackers and sutures in laparoscopic hernia surgery, duration takes 120 mins |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
All consenting patients planned for elective laparoscopic hernia repair |
|
| ExclusionCriteria |
| Details |
1.All hernias close to bony structures
2. Hernia patients with bleeding
3. Chronic pain due problems
4. Patients undergoing concomitant surgeries along with mesh repair
5. Parastomal hernias
6. Large hernias that require skin excision/ revision.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare postoperative pain scores between sutures with tackers vs tackers alone in laparoscopic hernia surgery |
pain is assessed at 6hours, 12 hours, 24hours, 1 week and one month after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduction in recurrence rates, seroma, hematoma formation, length of hospital stay |
recurrence rates & pain after 6 months & 1 yea, ssi within 90 days, seroma formation within 1 month |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
12/05/2026 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
ouble-crown fixation of intra-peritoneal mesh during laparoscopic ventral hernia repair was quicker, was less painful immediately post-operative and after 3 months, and did not increase the recurrence rate at 24 months. In hernias at a distance from the bony borders of the abdomen, transfascial sutures can be omitted if a double crown of tackers is placed. |