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CTRI Number  CTRI/2022/05/042701 [Registered on: 20/05/2022] Trial Registered Prospectively
Last Modified On: 15/05/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Comparison between onlay and sublay mesh repair for ventral hernias 
Scientific Title of Study   A Prospective Controlled Study For Comparision Between Onlay Versus Sublay Mesh Repair In Ventral Hernias In Our Population 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Paruchuri Anvitha 
Designation  Junior Resident, Post graduate student  
Affiliation  Institutional Ethics committee, Svmchrc  
Address  Department of General Surgery, Sri Venkateshwara Medical College Hospital and Research Centre, Ariyur
Dr Paruchuri Anvitha, Department of General Surgery, Sri Venkateshwara Medical College Hospital and Research Centre, Ariyur, Pondicherry 605102
Pondicherry
PONDICHERRY
605102
India 
Phone  9110336220  
Fax    
Email  anviparuchuri09@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr R Muthukumar  
Designation  Professor 
Affiliation  Institutional Ethics committee, Svmchrc  
Address  Department of General Surgery, Sri Venkateshwara Medical College Hospital and Research Centre, Ariyur
Prof. Dr. R. Muthukumar, Department of General Surgery, Sri Venkateshwara Medical College Hospital and Research Centre, Ariyur, Pondicherry 605102
Pondicherry
PONDICHERRY
605102
India 
Phone  9110336220  
Fax    
Email  drmuthu0402@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Paruchuri Anvitha 
Designation  Junior Resident, Post graduate student  
Affiliation  Institutional Ethics committee, Svmchrc  
Address  Department of General Surgery, Sri Venkateshwara Medical College Hospital and Research Centre, Ariyur
Department of General Surgery, Sri Venkateshwara Medical College Hospital and Research Centre, Ariyur, Pondicherry 605102
Pondicherry
PONDICHERRY
605102
India 
Phone  9110336220  
Fax    
Email  anviparuchuri09@gmail.com  
 
Source of Monetary or Material Support  
Sri Venkateshwara Medical College Hospital and Research Centre 
 
Primary Sponsor  
Name  Dr Paruchuri Anvitha 
Address  Sri Venkateshwara Medical College Hospital and Research Centre, Ariyur, Pondicherry, 605102 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Paruchuri Anvitha  Sri Venkateshwara Medical College Hospital and Research Centre  Department of General Surgery, Sri Venkateshwara Medical College Hospital and Research Hospital, Ariyur, Pondicherry, 605102
Pondicherry
PONDICHERRY 
9110336220

anviparuchuri09@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients of both sexes with age more than 18 years and with any of the following will be included in the study:
• Primary hernias with single defects (Umbilical, epigastric, paraumbilical, hypogastric )
• All incisional hernias regardless of size. 
 
ExclusionCriteria 
Details  Patients under the age of 18.
Obstructed or strangulated hernia.
Immunocompromised patients .
Patient with multiple defects ( swiss cheese defect).
Pregnancy 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
This study helps in evaluating the advantages of Sublay meshplasty over Onlay meshplasty in terms of postoperative complications
 
15days
 
 
Secondary Outcome  
Outcome  TimePoints 
This study helps in evaluating the advantages of Sublay meshplasty over Onlay meshplasty in terms of postoperative complications and recurrence of hernia at surgical site.
 
1month
 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   20/05/2022 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

A Ventral Hernia is defined by a protrusion through the anterior abdominal wall fascia

• These defects can be characterised by spontaneous or acquired or by their location on the abdominal wall.

 

Ventral hernia is commonly encountered in surgical practice.  An estimated one-quarter of all individuals are either born with or will develop a ventral hernia in their lifetimes. It is a common surgical problem and refers to fascial defect of the anterolateral parietal abdominal wall fascia and muscles, through which intermittent or continuous protrusion of intra-abdominal or preperitoneal contents occurs.

Types of ventral Hernia:These hernias have various types that can be categorized into either de novo or incisionalwhich occurs at the site of a pervious surgical scar. Both types have two subtypes, lateral and midline ventral hernias .

Incisional (Acquired) Hernia

Epigastric Hernia

Umbilical Hernia

Para-umbilical Hernia

Hypogastric Hernia

Incidence of incisional hernias is 15-20% of all abdominal wall hernias and umbilical and epigastric hernias constitute 10% of hernias.

Female to male ratio for incisional hernias is 2:1.

Patient related factors  linked to ventral hernia formation include obesity, older age, male gender, sleep apnea, emphysema, and prostatism.

Poor wound healing or wound infection, poor surgical techniques can lead to incisional hernias.

Despite advances in surgical technique and prosthetic technologies, the risks for recurrence and infection are high following the repair of ventral hernias. 

 

High-quality data suggest that all ventral hernia repairs should be reinforced with prosthetic repair materials. 

The current standard for reinforced hernia repair is synthetic mesh, which can reduce the risk for recurrence in many patients. 

The most 2 positions for mesh application in open repair are the onlay repair where the mesh is positioned over the anterior rectus sheath, and the sublay (retromuscular) repair, the more commonly known as stoppa technique .

Permanent synthetic mesh can pose a serious clinical problem in the setting of infection . However, it is the understanding of the abdominal wall that has made complex procedures possible including myofascial and musculocutaneous advancement flaps through component separation and muscular release.

These advancements have enabled surgeons the technical ability to use prosthetics in different manners and grant closure of abdominal defects that were considered impossible in the past.

 
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