| CTRI Number |
CTRI/2023/01/048745 [Registered on: 04/01/2023] Trial Registered Prospectively |
| Last Modified On: |
21/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Laparoscopic hernia surgery |
|
Scientific Title of Study
|
Comparison between tackers vs sutures in mesh fixation for laparoscopic IPOM repair of umbilical hernia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Brijesh Kumar Sundaray |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College |
| Address |
Department of General surgery,3rd floor,OPD building,Kasturba hospital,Manipal
Manipal,
Udupi,
Karnataka
Pin-576104
Udupi
KARNATAKA
576104
India |
| Phone |
6370372522 |
| Fax |
|
| Email |
Docbksy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Badareesh L |
| Designation |
Professor and HOU |
| Affiliation |
Kasturba Medical College |
| Address |
Department of General Surgery,
3rd floor,OPD Building,
Kasturba hospital,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
badareesh.l@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Steffi Dcruz |
| Designation |
Assistant professor |
| Affiliation |
Kasturba Medical College |
| Address |
Department of General Surgery,
3rd floor,OPD building,
Kasturba hospital,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9686676584 |
| Fax |
|
| Email |
Steffi.dcruz@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba hospital,Manipal,Udupi,karnataka |
|
|
Primary Sponsor
|
| Name |
Brijesh kumar Sundaray |
| Address |
Department of General Surgery,3rd floor,OPD building,Kasturba hospital,Manipal,Karnataka |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Brijesh Kumar Sundaray |
Kasturba hospital |
Department of General Surgery,Kasturba hospital,Manipal,Udupi,Karnataka
Udupi
KARNATAKA |
6370372522
docbksy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba hospital IEC-2 |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
All patient with umbilical hernia planned for Lap IPOM repair |
|
| ExclusionCriteria |
| Details |
Congenital hernias,recurrent hernias,Morbid obesity (>35), Pregnant females,hernia with complications(obstruction,strangulation) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The patients are to be followed up postoperatively to calculate the individual pain scores of both the groups using sf MPQ scale. |
Post operative day (POD) 1,POD 2,POD 7 or 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Status of analgesics IV/oral, |
POD 3,4,5,6 |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/01/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Mesh repair is regarded as obligatory for umbilical hernias with a defect greater than 4 cm. There are no limits to laparoscopic and open IPOM insertion as regards hernia size. The two methods of mesh fixation are compared and evaluated in this study.The tacker are expensive and easy to use while sutures are relatively cheap and requires skills.In the intraoperative period ,the patient will be divided on the basis of type of material used for mesh fixation .At the end of the study we can find out the optimal method of mesh fixation in laparoscopic IPOM repair in terms of post operative pain post surgery. |