A Comparative Longitudinal Study Between Bilateral Totally Extraperitoneal Repair and Unilateral Totally Extraperitoneal Repair Among Patients of Unilateral Inguinal Hernia at a Tertiary Care Hospital in Eastern Nepal
Phase: NA
Conditions: Inguinal Hernia
Sponsor: B.P. Koirala Institute of Health Sciences

Date 15/03/2018 
 
 
Tittle: A Comparative Longitudinal Study Between Bilateral and Unilateral Totally Extra 
Peritoneal Repair Among Patients with Unilateral Inguinal Hernia at Tertiary Care Hospital in 
Eastern Nepal 
Running Tittle: Bilateral vs Unilateral Totally Extraperitoneal Repair Among Patients With 
Unilateral Inguinal Hernia 
 
  
AIMS AND OBJECTIVES: 
AIMS 
To study the feasibility and desirability of bilateral TEP repair in patients with clinically unilateral 
hernia  
Primary Objective: To study and compare pain and complication rates in unilateral and bilateral 
total extra peritoneal repair.  
Secondary Objective: 
 
• To study the recurrence in both unilateral and bilateral TEP repair 
• To study the difference in duration elapsed before return to work and day to day activity. 
• To find the incidence of occult hernias in regional population. 
 
Research Hypothesis : 
 
Null Hypothesis-There is no difference betweenthe effects of bilateral TEP repair in patients with 
clinically unilateral hernia  
Alternate hypothesis- There is a difference between the effects of bilateral TEP repair in patients 
with clinically unilateral hernia 
 
 
 
 

Review of Literature 
 
It has been reported that there is a significantly high chance of contralateral concurrent occult or 
subsequent inguinal hernia in patients with unilateral inguinal hernia. The objective of this study 
is to investigate the feasibility of bilateral laparoscopic exploration for all unilateral cases followed 
by laparoscopic bilateral TEP repair and to compare complications, recurrence rates, postoperative 
pain, and operative duration with prospectively performed unilateral repairs. 
Materials and Methods      
: 
 
a) Type of study design: A hospital based longitudinal comparative study. 
b) Study Population: Patients attending the outpatient department of surgery with complain of 
unilateral inguinal hernia  
c) Population/Participants: 
      Inclusion criteria 
1. Age group of 16 years and above  
2. Clinically diagnosed unilateral inguinal hernias       
        Exclusion criteria 
1. Complicated hernia (obstructed, strangulated) 
2. Past history of pelvic radio-therapy  
3. Patient unfit for general anesthesia 
4. Patient not giving consent 
d. Setting: The study was conducted at B.P. Koirala institute of Health science (BPKIHS), Dharan, 
an independent health university in Nepal. 
e. Study period: The study was conducted over a period of 12 months from March 2018 to March 
2019. 
f. Ethical clearance: The study was performed in accordance with the principle of the declaration 
of Helsinki and after approved by the Institutional Review Committee and Protocol committee 
 
 

ENROLLMENT OF PATIENTS  
Patients attending the OPD for inguinal hernia will be counseled about the trial and fully 
encouraged to understand the difference in the two procedures and an informed consent 
acquired after which they will be enrolled in the study for a bilateral TEP to be performed 
on them, and controls should be taken from the patients who denied for bilateral repair 
for unilateral hernia and undergo   unilateral TEP repair. 
 
 
At discharge the patient will be given a chart to fill which will have daily visual assessment 
of pain as well as the following instructions: 
• To return to normal activity as soon as possible. 
• To record all analgesic intake 
• To return for follow up at 7days, 3 months, 6 months 
• To return at any time should any complication arise. 
• During the follow up assessment data will be recorded using annexure. 
 
 
 
 
 
 
 

ANNEXURES 
PRO FORMA 
Patient ID: ………………. 
Serial No.: ……………………….  Date: ………………………  
Name : -………………………………… IP No.: ……………….... 
Age 
: -…………............. Years  
Phone no. 
Address: -………………………………………... 
Diagnosis: ……………………………………… 
Symptom duration: .....................days 
Hernia:  
unilateral / bilateral 
BMI: 
Education: 
Income: 
Symptoms: 
• pain  
 
 
 
 
- yes/no, 
• anorexia 
 
 
 
 
- yes/no 
• nausea/vomiting  
 
 
- yes/no 
• fever 
 
 
 
 
-yes/no 
 
General physical examination: 
BP:                        Pulse:             Temperature:               Respiratory rate: 
Jaundice:               Anemia:        Lymphadenopathy:      Cyanosis: 
Clubbing:              Edema:         Dehydration: 
 

 
 
PRE-OPERATIVE WORK UP 
 
 
 
 
 
VAS Score: 
Blood pressure: 
BMI: 
Height: 
Weight 
Dimension of Hernia 
Reducible 
Duration of Hernia 
Primary or recurrent 
Bilateral or Unilateral 
Occupation: 
Co-morbidity: 
 

Pain Assessment 
Oral analgesic name: 
Oral analgesic dose: 
Oral analgesic frequency per dose: 
Intravenous analgesic name: 
Intra venous analgesic dose: 
Intra venous analgesic frequency per dose: 
VAS score: 
Post-Operative Assessment on evening of surgery 
General Condition: 
 
Urinary Retention: 
 
Early recurrence: 
 
Bleeding from Port site: 
 
Hematoma Formation: 
 
Pneumoscrotum: 
Pain: (6h)-   
           (12h)- 
           (24h)- 
 
Intra Operative Assessment 
Operation Time 
 
Bleeding(ml) 
 
Peritoneal Breach 
 

Nerve Injury 
 
Vas Deferens Injury 
 
Tearing of Inferior Epigastric Vessels 
 
Major Visceral Injury 
 
Major Vascular Injury 
 

 

Post-operative pain will be evaluated by pictorial visual analogue scale within next 7days. They 
will be questioned about the severity of pain by using visual analogue scale. The pain score of 1-
2 will be regarded as mild pain, 3-5 moderate pain 6-8: severe pain and 9-10: worst pain. An 
additional requirement of analgesic after 24 hrs post-operatively  will be noted. 
 
 
 
DAY 1= 
DAY 2= 
DAY 3= 
DAY4= 
DAY5= 
DAY6= 
DAY7= 
 
 
 
 
 

 
 
FOLLOWUP 
Number of Follow up Visits  
Recurrence 
 
Any complications: 
 
Which Complication: 
 
VAS score(Visit 1): 
 
VAS score(Visit 2): 
 
VAS score(Visit 3): 
 
Analgesic intake 
(Visit 1): 
(Visit 2): 
(Visit 3): 
 
Recurrence 
Seroma 
Pneumoscrotum 
Hematoma  
Neuralgia 
 
 

Date 15/03/2018 
 
 
Participant Informed Consent Form 
 
Protocol Number: _______________ 
Participant Identification number for the study: ______________ 
Title of the research:’’ A Comparative Longitudinal Study Between Bilateral and Unilateral 
Totally Extra Peritoneal Repair Among Patients with Unilateral Inguinal Hernia at Tertiary 
Care Hospital in Eastern Nepal’’ 
Name of the candidate: ____________________________, aged _______ years, 
address_________________. 
Telephone: 
(residence) 
______________(mobile) 
_____________(friend/parents) ___________ Email___________,  
 
The content of the information sheet dated___________ that was provided have been 
read carefully by me/explained in detail to me, in a language that I comprehend, and I 
have fully understood the contents. I confirm that I have had the opportunity to ask 
questions. 
 
The nature and purpose of the study and its potential risks/ benefit and expected duration 
of the study, and other relevant details of the study have been explained to me in detail. 
I understand that my participation is voluntary and that I am free to withdraw at any time, 
without giving any reason, without my medical care or legal right being affected. 
 
I understand that the information collected about me from my participation in this research 
and sections of any of my medical notes may be looked at by responsible individuals from 
BPKIHS. I give permission for these individuals to have access to my record.  
 
I hereby give consent to take part in the above study and allow to perform the procedure 
that may become necessary during the procedure.  

 I understand that these along with the information I provide may be used in my medical 
record, for purpose of publication in textbook or medical journal and dissertation purpose, 
or for medical education. 
 
The consent form has been signed by me when I was not under the influence of any 
drugs. 
 
 
Patient’s signature _____  
Researcher/Doctor’s Signature: _____ 
Date: 
Witness signature _______ 
 
If illiterate 
I have witnessed the accurate reading of the consent form to the potential participant, and 
the individual has had the opportunity to ask questions and to understand the nature of 
study. I confirm that the individual has given consent freely.  
Thumb print of participant 
Researcher/Doctor’s signature ________________  
Date: 
Witness signature __________________ 
 
 
 
 
 
 
 
Left 
Right