| 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
|
|
|
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
|
|
|
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. |