Aims, Objectives and Rationale

• Aims and Objectives

• To assess efficacy of SCOLA in ventral hernia.
• To assess feasibility of SCOLA in ventral hernia.
• To do hernia repair via a subcutaneous onlay
laproscopic approach [as compared to open hernia
repair]

• Rationale
• To reduce size of surgical wound and intervention
[as compared to open surgery] so there is reduction
in:
• Morbidity
• Operative time
• Hospitalization
• Patient recovery time
Introduction
Diastasis of the Rectus Abdominis Muscles (DMRA), defined as distancing from the
muscular borders in the midline greater than 2.2 cm, is not a rare condition. It is
characterized by bulging in the anterior wall of the abdomen when the patient exerts
contraction of the abdominal musculature and/or increase of the intra-abdominal
pressure, being often confused with hernia of the abdominal wall. DMRA is usually not
associated with symptoms, pain or discomfort, as well as any risk of complications. The
main complaint is aesthetic, a buldging at the abdomen, making its treatment,
nowadays, performed by plastic surgeons.

However, the simultaneous presence of a hernia of the anterior abdominal wall is not
uncommon. The concomitant presence of it and the non-use of meshes appear to be the
most important factors associated with failure to repair midline defects and consequent
recurrence of the hernia.

Treatment of DMRA, associated or not with abdominal wall hernias, in patients with
excess skin is usually performed by a large transverse incision in the lower abdomen
associated with dermolipectomy. Plication techniques are the most commonly used and
may or may not be associated with mesh placement.

The conventional laparoscopic technique of intraperitoneal mesh placement does not

seem to solve the problem of diasthesis unless it is also repaired by intracorporeal or
transfascial sutures. Nevertheless, the results have been questionable and
extraperitoneal alternatives have been described.

The aim of the present study was to describe a “new” technique (SCOLA) for the
correction of ventral hernias combined with the plication of the diastasis of the rectus
abdominis muscles and present the initial results of a series of cases.
Study Centre and Duration of study
 The entire study will be conducted at the
Department of General Surgery, M.G.M. Memorial
Medical College and MY Hospital Indore.
 One year
 Methodology [Materials and Methods]
Source of data and place of study
Cases reporting to Department of General Department of General Surgery, MY
Hospital, M.G.M. Memorial Medical College suitable for Endoscopic Anterior
Inguinal Hernioplasty.

Study design
Randomised Control Study

Study period
One year from issuance of letter of approval from surgical committee.

Sample size
All the patients fulfilling the inclusion criteria and attending surgery OPD at MY
Hospital from 8:30 am to 2:30 pm during the study period.
Patient selection
• Inclusion criteria

1. Ages 20-60 years.

2. Both Male and female patients.
3. Patients with unilateral inguinal hernia.

• Exclusion criteria

1. Patients on anticoagulant therapy.

2. Patients suffering from COPD.
3. Patients with immunocompromised status e.g. HIV
4. Extensive intra-abdominal adhesions
5. Very voluminous sliding hernias with the bowel
attached to the hernia sac
6. Late diagnosed strangulated hernias with
advanced bowel obstruction etc.
7. Previous lower abdominal surgery or pelvic
radiation.
8. Recurrent inguinal hernia
Methodology
Statistical Analysis
Data obtained will be analysed using suitable
software and appropriate statistical tests
Distribution and Determinant variables

Frequency and pattern of disease [distribution variable]

Age group [<20, 20-40 …] Number Percentage

Gender [M/F/Other] Number Percentage

Co-morbidity/risk factors Number Percentage

[smoking, DM, Alcohol,
etc.]
Distribution and Determinant variables
Determinant variable – exposure variable / outcome
variable

Percentage

Percentage

Percentage
Table 1
Distribution of patients according to age

Age Group Number Pe

<=20 years

21 - 40 years

41 – 60 years
 Table 2

Distribution of patients according to risk factors

Comorbidities Number Percentage

Diabetes

Obesity
Table 3
Distribution of patients according to sex
Sex Number Percentage

Male
Female
 Table 4
Distribution of patients according to duration of symptoms

Duration of disease Number Percentage

< 3 months

> 3 months

Total
 Record of possible complications
Table 5

Complications related with

YES/No
Laparoscopy

Bowel Injury

Vascular Injury

Gas Embolism

Bladder Injury

Bowel Obstruction

Subcutaneous

Emphysema

Arrythmias

Shoulder pain
 Record of possible complications
Table 6

Complications related with Patient YES/No

DVT

Urinary retention

Ileus

Cardiopulmonary complications
Record of possible complications
Table 7

Complications related with YES/No

hernioplasty
Port site problems

Recurrence

Hematoma

Seroma

Hydrocele

Infertility

paraesthesia

Anaesthesia

Groin pain
 Record of possible complications
Table 8

Complications related
YES/No
with mesh
Folding

Contraction

Infection

Rejection

Erosion
Proforma

Name

Ip/Op no.

Age at time of surgery

Address

Mobile no.

Religion

Socio-economic status

Investigations

Type of surgery
The following will recorded for all patients

Follow up
 7 days, 14 days, 21 days, 1 month, 3 month, 6 months, 1 year.
 

Observations
 

Expected outcomes
 
Informed Consent Form (English)

Study title: A Randomized Control Study of Efficacy/Feasibility of Endoscopic Anterior Inguinal

Hernioplasty

 Subject

Full name

Date of birth / age

Address
1. I have been explained the nature of study by the investigator and had the opportunity to ask
questions.

 2. I understand that my participation in the study is voluntary and that I am free, to withdraw
at any time, without giving any reason and without my medical care or legal rights being
affected.

 3. I understand that the Ethics & scientific review committee and the regulatory authorities will
not need my permission to look at my health records both in respect of the current study and
any further research that may be conducted in relation to it, even if I withdraw from the trial.
However, I understand that my identity will not be revealed in any information released to third
parties or published.

 4. I agree not to restrict the use of any data or results that arise from this study provided such a
use is only for scientific purpose(s).

5. All information about the study are given, still, I agree to take part in the above study.

NOTE: For illiterate participants this consent come information letter is manually read in front
of them and their thumb impression will be taken after complete satisfaction / understanding
about the matter written in the form in case of minor the consent will be taken by the legal
guardian
1 Signature (thumb impression) of the subject / legally acceptable representative:

2 Signatory’s Name and address__________________________________

Date:

3. Signature of the investigator______________________; Date

4 Study investigator’s name Ramendra Singh Gurjar 8962478000 PG resident

5 Name of the guide Dr. Arvind Ghanghoria; Ph. No. 9827215466

Professor and Head Gen. Surgery.

Signature of the witness ________________Date ________

Received a signed copy of participant information document and consent form

Patient consent form
[Hindi]
PATIENT INFORMATION DOCUMENT
 
Study title: A Randomized Control Study of Efficacy/Feasibility of Endoscopic Anterior
Inguinal Hernioplasty
 
 
Invitation: I, Dr. Meher Kalsi, wish to invite you to take part in a research study. My
study is an observational or non-interventional research study and your participation is
voluntary. After giving the consent also, you have all the rights to withdraw your
authorization to use and share your information at any time during course of the study.
Before you decide to authorize yourself and give consent for the purpose of study, it is
important for you to understand the purpose of study and reasons for choosing you as a
part of this study. Please take time to read the following information carefully and
discussing it with friends, relatives and any doctor. I, along with my guide, co guides and
your treating doctor will always be there to clear any doubt or information about your
role or any other query regarding the study. Take time to decide whether you would or
would not like to take part in the study.
S. NO. QUERY RESPONSE

The purpose of the study is to collect medical and hea

1. What is the purpose of information about you as a participant of study. My ro
the study? principal investigator is to collect the data based on in
gathered from you and your treating doctor during the
study that involves the management of your inguinal h

2 What am I suffering You are suffering from Inguinal hernia, a very common
from ? pathology.

3 What are the various
treatment options
available for treatment
of inguinal hernia ?
There are many treatment modalities for inguinal hern
from Open Mesh repair to Laparascopic and Endoscop
Since it is a randomized control study, and your doctor
you to be a suitable candidate, you will be randomly se
either Laparoscopic or Endoscopic mesh repair.

4 What are the It is a more advanced technique for hernia repair whic
advantages of advantages like
endoscopic anterior o lesser operative time,
hernia repair ? o lesser hospitalistion time.
o Cosmetically better scar.
o Lesser risk of bowel injury, bowel adhesions.

5 Would the procedure You will be given general anaesthesia.

be done under
anaesthesia ?
6 What are the disadvantages The procedure might include intra operative complications like pain (neuralgia) due
associated with endoscopic to damage to nerves, haemorrhage, etc.
anterior inguinal hernia repair ? Late complications like recurrence.

Complications related to general anaesthesia like intraop respiratory distress, heart

rhythm disturbances and later, increased nausea and vomiting, muscle weakness,
excessive sedation.
and in rare cases aspiration pneumonitis.

7. You are suffering from inguinal hernia. You have opted for either endoscopic or
laparoscopic surgery; hence, you are a suitable participant for this study
What is the purpose of
choosing me as a
participant for this study?

If you give authorization and written consent to participate for the study, we will
8. note the data related to your medical and health related information in the study
What will happen to me if I take proforma.
part?

Your role is to answer the questions of the principal investigator and allow her to
What do I have to do? note the details of your procedure and follow up visits.
9.

10. There are no side effects of your participation in the study. Institutional ethical
What are the side effects of taking committee protects the confidentiality and rights of the participant and it will happen
part in this study? in your case.
11. The benefit will be of medical fraternity in understanding the
What are the possible benefits various aspects and that will help the community.
of taking part in the study?

Will my taking part in this Yes, there is no clause of disclosure of confidentiality of

12. study be kept confidential? participants during or after the study.

13. The principal investigator will submit thesis based on the results
What will happen to the and she may submit it to various journals for publications.
results of research study?

14. Department of Surgery, M. G. M. Medical College, Indore is

Who is organizing and organising the research. All treatment in our medical college is free
funding the research? of cost so there is no role of funding for the research.

15. Who has reviewed the study? Scientific review board and Institutional Ethics Committee, M. G.
M. Medical College, Indore has approved the study.

16. In this study, participation is voluntary and participant is free to

What if I want to withdraw withdraw at any time, without giving any reasons. It will not
from participation? affect the standard of medical care or legal rights given to the
participant.