A Comparative Study on Effects of Defect Closure Versus Non-Closure in Laparoscopic Totally Extraperitoneal Repair of Direct Inguinal Hernia
Conditions: Hernia, Direct Inguinal Hernia, Seroma Following Procedure
Sponsor: B.P. Koirala Institute of Health Sciences

Date 01/09/2020 
 
 
Title: A Comparative Study on Effects of Defect Closure Versus Non-Closure in Laparoscopic 
Totally Extraperitoneal Repair of Direct Inguinal Hernia 
 
Running Title: Study on Effects of Defect Closure in Laparoscopic TEP Repair of Direct Inguinal 
Hernia 
 
  
AIMS AND OBJECTIVES: 
Aim: To Compare the Effects of Defect Closure versus Non-Closure on Outcomes of 
Laparoscopic TEP Direct Inguinal Hernia Repair. 
Primary Objectives  
• 
To compare Seroma formation rate in defect closure and non-closure groups.   
• 
To compare the score of pain in VAS on different interval of time in both groups. 
 
Secondary objectives  
• 
To evaluate the operative time and the length of post-operative hospital stays in both groups.  
• 
To evaluate the complication rate: vessel / visceral injury / vas injury/ peritoneal tear.  
• 
Days to resume normal activities and work. 
   
RESEARCH HYPOTHESES  
Null Hypothesis: There is no difference between defect closure and non-closure of Laparoscopic 
TEP direct Inguinal hernia repair.  
  
Alternate Hypothesis: Defect closure is superior to non-closure in laparoscopic direct inguinal 
hernia repair.  
 
 

 
 
Review of Literature 
 
Materials and Methods: 
 
a) Type of study design: A prospective cohort study reported as the CONSORT guideline. 
b) Study Population: Patients attending the outpatient department of surgery with complain of 
inguinal hernia  
c) Population/Participants: 
      Inclusion criteria 
1. Age greater than18 years  
2. uncomplicated direct inguinal hernia (≥M3)          
Exclusion criteria 
1. Defect size ≤M2 
2. Complicated hernia (irreducible, obstructed, or recurrent hernia) 
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 September 2020 to 
August 2021. 
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 with inguinal hernia presenting to surgery OPD with the inclusion criteria of age greater 
than 18 years and uncomplicated direct inguinal hernia (≥M3) were enrolled in the study. A 
total of 88 patients were enrolled in the study using the purposive alternate number sampling 

technique. They were divided into 2 groups: 44 patients each in the defect closure and non-
closure groups. All patients were explained and familiarized with the visual analog score (VAS) 
pain chart preoperatively. 
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 10days, 1 months, 3 months and 6 months 
• To return at any time if any complication arises. 
• During the follow up, assessment data will be recorded using annexure. 
 
 
 
 
 
 
 

ANNEXURES 
Proforma  
Particulars of patient Serial no:  
Patient ID:  
Date:  
Name:   
Age:   
  
  
  
  
  
  
  
Sex: Male / Female  
Address:  
Occupation: No / Student / Business / Service/ Others  
Religion: Hindu / Buddhist / Muslim / Kirati / Christian  
Marital status: Unmarried / Married  
Socio-economic status: Low / Medium / High  
Phone no:  
History   
  
Examination of the patient  
1. Direct/ Indirect:   
2. Defect Size: if applicable   
3. Content: Empty/Omentum/Bowel   
4. Cough impulse: Present/Absent   
5. Reducibility: Complete/Incomplete   
  
ASA grading:   
Operative Procedure and Date:   
Operative Time:   
Operative Detail:   
1. Type of hernia:   

2. Contents:   
3. Type of Mesh used  
  
Intra Operative Complications:    
1. Injury to Visceral organs: Yes/No   
2. Injury to vessels: Yes/No   
3. Peritoneal tear: Yes/No   
4. Injury to vas: Yes/No   
  
Late complications:     
1. Seroma formation: Yes/No   
2. Incisional hernia/recurrence: Yes/No   
 
FOLLOWUP 
Follow up Performa (seroma formation questionnaire to be filled up by 10 days, 30 days, 3 
months and 6 months)  
Day 10 
1. Seroma formation: yes / No 
2.  Pain:          yes/ No 
3. Recurrence: yes / No 
1 months 
1. Seroma formation: yes / No  
2.  Pain:          yes/ No  
3. Recurrence            yes/ No   
3rd month  
1. Seroma formation: yes / No   
2. Pain:          yes / No   
3. Recurrence             yes / No   
6th month  
1. Seroma formation: yes / No   
2. Pain:          yes / No   
3. Recurrence            yes / No  

 
Date 01/09/2020 
 
 
Participant Informed Consent Form  
Protocol Number: _______________  
Participant Identification number for the study: ______________  
Title of the research: “A Comparative Study on Effects of Defect Closure Versus Non-Closure in 
Laparoscopic Totally Extraperitoneal Repair of Direct Inguinal Hernia”. 
 
Name  of  
the  
candidate:  
______________,  
age  
_______  
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 and any 
other medical service that may become necessary during the procedure.  
I also consent for medical photographs/ video and I have been informed that these photographs/ 
video will be used without revealing the identity. 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________________  
Witness signature __________________  
Date ________________ 

  
If not literate  
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: