| CTRI Number |
CTRI/2023/05/052244 [Registered on: 02/05/2023] Trial Registered Prospectively |
| Last Modified On: |
01/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparision of two hernia operation techniques (Sublay Vs Onlay) |
|
Scientific Title of Study
|
Sublay vs. Onlay mesh hernioplasty in ventral hernia - A double blinded randomised control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SOWMYA RAMGOPAL |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
JIPMER |
| Address |
Department of Surgery, Unit 1, Ward 31,
JIPMER CAMPUS , DHANVANTRI NAGAR , GORIMEDU , PONDICHERRY 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9910795630 |
| Fax |
|
| Email |
sowmyaramgopal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suresh Kumar S |
| Designation |
Professor |
| Affiliation |
JIPMER |
| Address |
Department of Surgery, Unit 1, Ward 31
JIPMER CAMPUS , DHANVANTRI NAGAR , GORIMEDU , PONDICHERRY 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9788637893 |
| Fax |
|
| Email |
drsureshkumar08@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SOWMYA RAMGOPAL |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
JIPMER |
| Address |
Department of Surgery, Unit 1, Ward 31,
JIPMER CAMPUS , DHANVANTRI NAGAR , GORIMEDU , PONDICHERRY 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9910795630 |
| Fax |
|
| Email |
sowmyaramgopal@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
Pondicherry |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sowmya Ramgopal |
JIPMER |
Depart of Surgery, Unit 1, Ward 31, DHANVANTARI NAGAR , GORIMEDU , PONDICHERRY 605006
PONDICHERRY
605006
Pondicherry
PONDICHERRY |
9910795630
sowmyaramgopal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Intervention Studies JIPMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: K439||Ventral hernia without obstructionor gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Onlay Meshplasty |
Onlay meshplasty is the standaed of care that is being implemented in JIPMER owing to its technical feasilibity and lesser duration.
In onlay mesh repair, the peritoneal surface and fascia were
closed with polypropylene sutures. The subcutaneous tissue
was released to place the mesh on the anterior aspect of the
fascia. The mesh was placed on the anterior aspect of the fascia with at least 5 cm overlapping the fascial edges at all sides
and was fixed to the fascia with polypropylene sutures. In all patients, a vacuum drain was placed above the mesh, and the skin
and subcutaneous tissue were closed with absorbable sutures.
Post operative outcome will be measured in terms of pain , ssi ,seroma formation , recurrence , length of hospital stay , duration of drain kept in situ etc
|
| Intervention |
Sublay Meshplasty |
Sublay meshplasty is a novel , less explored technique which we are trying to introduce.
In sublay mesh repair, the posterior aspect of the rectus muscle was dissected and a polypropylene mesh was placed below the rectus muscle. The mesh was fixed to the posterior
rectus sheet using polypropylene sutures. If the fascia could
be closed without tension, it was sutured to the closest part of
the mesh. In all patients, the mesh was placed so that at least 5
cm overlapped the fascia at all sides.
Post operative outcome will be measured in terms of pain , ssi ,seroma formation , recurrence , length of hospital stay , duration of drain kept in situ etc
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
ALL ELECTIVE PATIENTS ABOVE 18 YEARS WHOA RE TO UNDERGO ELECTIVE MESHPLASTY FOR VENTRAL HERNIA REPAIR.
2.) VENTRAL HERNIA WITH SIZE DEFECT BETWEEN 2-8CM |
|
| ExclusionCriteria |
| Details |
MORBID OBESITY WITH BMI > 40KG/M2
PATIENTS WITH ABDOMINAL DISEASE AND END STAGE LIVER DISEASE
PATIENTS WITH OBSTRUCTIVE UROPATHY - BPH
PATIENTS PRESENTING AS AN EMERGENCY LIKE STRANGULATED HERNIA WITH SIGNS OF OBSTRUCTION
PRE EXISTING SIGNS OF INFECTION AT THE SITE OF HERNIA
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of seroma formation, wound infection between the sub-lay and on-lay mesh repair. |
Daily during hospital stay after the procedure and then telephonic follow up on 7-10 days, 1 month and 3 month from procedure date |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the impact of these two surgical techniques on the basis of operative time, postoperative pain (POD 0, 1 and 2), recurrence on drain output, length of hospital stay etc.
|
Daily during hospital stay after the procedure and then telephonic follow up on 7-10 days, 1 month and 3 month from procedure date |
|
|
Target Sample Size
|
Total Sample Size="87"
Sample Size from India="87"
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)
|
08/05/2023 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Ventral hernia repair is among the most frequently performed surgical operation globally and the two operative techniques most frequently used in cases of ventral hernia are the onlay and sublay repair.
The repair of ventral hernias has always been a big challenge to the surgeons.
Different mesh placement techniques has been followed. Onlay (Overlay) repair places the mesh directly on the anterior fascia. Inlay repair places the mesh inline with the hernia defect and secures the mesh circumferentially to the edges of the fascia. Sublay repair refers to retro rectus or preperitoneal mesh placement. Intraperitoneal onlay mesh (IPOM) refers to an intraperitoneal mesh position.
Mesh hernioplasty method was considered as a golden choice to prevent or minimize incidence of recurrence but the question is where surgeons should put the mesh sublay or onlay? Although, it remains uncertain as to which repair technique has shown to be more successful.
This study aims to compare Onlay with Sublay mesh repair for open incisional hernia and evaluate outcomes related to post-operative complications, recurrence of hernia, length of hospital stay etc. |