| CTRI Number |
CTRI/2019/05/019115 [Registered on: 14/05/2019] Trial Registered Prospectively |
| Last Modified On: |
13/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparision between mesh fixation by absorbable tack and nonabsorbable in laparoscopy ventral hernia repair. |
|
Scientific Title of Study
|
To Compare absorbable versus non absorbable tacker for laparoscopy ventral hernia repair.a prospective randomised study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashok D Thanthvaliya |
| Designation |
second year resident, General surgery, |
| Affiliation |
Government medical college, Bhavnagar |
| Address |
Department of surgery,sir T Hospital,Jail road,Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9099328391 |
| Fax |
|
| Email |
ashokvaliya20790@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajan B Somani |
| Designation |
Additional Professor |
| Affiliation |
Government medical college, Bhavnagar |
| Address |
Department of surgery,sir T Hospital,Jail road, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
|
| Fax |
|
| Email |
somanirajan@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajan B Somani |
| Designation |
Additional Professor |
| Affiliation |
Government medical college, Bhavnagar |
| Address |
Department of surgery,sir T Hospital,Jail road, Bhavnagar
GUJARAT
364001
India |
| Phone |
|
| Fax |
|
| Email |
somanirajan@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery, Sir T Hospital, Jail Road, Bhavnagar - 364001(Gujarat) |
|
|
Primary Sponsor
|
| Name |
Department of General Surgery |
| Address |
Sir T Hospital, Jail Road, Bhavnagar - 364001(Gujarat) |
| 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 Ashok D Thanthvaliya |
Sir T Hospital |
Department of General Surgery, Sir T Hospital, Jail Road, Bhavnagar - 364001(Gujarat)
Bhavnagar
GUJARAT |
9099328391
ashokvaliya20790@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, GMC, Bhavnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K439||Ventral hernia without obstructionor gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Laparoscopic ventral hernia repair |
Laparoscopic ventral hernia repair using absorbable tackers |
| Comparator Agent |
Laparoscopic ventral hernia repair |
Laparoscopic ventral hernia repair using nonabsorbable tackers |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All the patients between 18 to 65 year age with uncomplicated ventral hernia |
|
| ExclusionCriteria |
| Details |
infants and children(<18 years),patients with large irreducible hernia,strangulated hernia,patients unfit for general anaesthesia due to any reason
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Patient comfort in post-operative period (measured by Visual Analog Scale for post operative pain)
Post operative complications
Recurrence rates.
Post operative hospital stay
|
7 day,1 month,3 month,6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Post operative complication.
Recurrence rate.
|
1month,3month,6month |
|
|
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)
|
23/05/2019 |
| 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
|
1. Ather CV, Kubasiak JC,Daly SC, Janssen I,Deziel DJ, Millikan KW, Myers JA and Luu MB. The utilisation of laparoscopy in ventral hernia repair; an update of outcomes analysis using ACS-NSQIP data.surg endosc 2015; 29:10991104.
2. Zhang Y, Zhou H, Chai Y, Cao C,Jin K and Hu Z. laparoscopic versus open incisional and ventral hernia repair; a systemic review and meta analysis.World J surg 2014; 38: 22332240.
3. Pham CT, Perera, Watkin DS, and Maddern GJ. Laparoscopic ventral hernia repair; a systemic review.surg endosc 2009; 23: 4-15.
4. Melvin WS, Renton D. Laparoscopic ventral hernia repair. World J Surg. 2011;35:1496-99.
5. Olmi S, Scaini A, Cesana GC, Erba E. laparoscopic versus open incisional hernia repair: an open randomised entral or incisional hernia repair.Cochrane Database Syst rev 2011;3, CD007781.
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this study regarding laparoscopic ventral hernia repair - 2 groups of 30 patients each (total sample size-60) ,selected randomly will be compared in terms of hernia repair by using absorbable vs nonabsorbable tackers.
Outcome in terms of post operative pain,hospital stay,recurrence rate,post operative complication. |