Comparison of Extended Totally Extra Peritoneal Repair (ETEP) and Subcutaneous Onlay Endoscopic Approach (SCOLA) for the Treatment of Para Umbilical Hernias (PUH) in Terms of Intraoperative Factors(Operative Time, Hernial Contents, Divarication of Recti, Conversion to Any Other Technique) and Postoperative Complications( Surgical Site Infection, Seroma Formation, Postoperative Pain, Rescue Analgesia, Drain Output)
Phase: NA
Conditions: Paraumbilical Hernia
Sponsor: King Edward Medical University

Comparison of Extended Totally Extra peritoneal Repair (ETEP) and Subcutaneous OnLay 
Endoscopic Approach (SCOLA) for the treatment of Para umbilical Hernias (PUH) in terms of  
intraoperative factors and postoperative complications. 
 
Date of document: 18/12/2025 
  SYNOPSIS   
  
  
  
 
  
Submitted By:  
DR KASHAN AZEEM HASSAN   
POST GRADUATE RESIDENT GENERAL SURGERY WEST SURGICAL WARD KEMU  
  
  
Supervisor:  
  
PROF DR AHMED UZAIR QURESHI   
HEAD OF DEPARTMENT WEST SURGICAL WARD KEMU  
  
  
  
King Edward Medical University  
  

Comparison of Extended Totally Extra peritoneal Repair (ETEP) and Subcutaneous OnLay 
Endoscopic Approach (SCOLA) for the treatment of Para umbilical Hernias (PUH) in terms of  
intraoperative factors and postoperative complications. 
 
Date of document: 18/12/2025 
Lahore – Pakistan  
  
  
 
Title of Research Project:  
Comparison of Extended Totally Extra peritoneal Repair (ETEP) and Subcutaneous OnLay Endoscopic 
Approach (SCOLA) for the treatment of Para umbilical Hernias (PUH) in terms of intraoperative factors and  
postoperative complications.  
Synopsis Submitted For:  
  
        MD / MS / MDS            Ph. D  
        M. Phil                            
 Research Grant  
Discipline:  
  
MS General surgery   
Name Of The Applicant:  
  
Dr Kashan Azeem Hassan  
D.O.B:   
  
24 April 1997  
Nationality:  
  
Pakistan  
  
NIC #:  
  
3540195824973  
Address:  
  
Village Dandian kalakhtai Road post office shadara bagh Lahore  
  
Phone #:  
  
03488676336  
Email:  
  
kashanazeem15@gmail.com   
  
  
Qualifications (list all; with date of graduation):  
                   Qualification                                            Year                                                   Institution  
  
  
KING EDWARD MEDICAL UNIVERSITY, LAHORE

Comparison of Extended Totally Extra peritoneal Repair (ETEP) and Subcutaneous OnLay 
Endoscopic Approach (SCOLA) for the treatment of Para umbilical Hernias (PUH) in terms of  
intraoperative factors and postoperative complications. 
 
Date of document: 18/12/2025 
MBBS  
  
Intermediate   
  
Matric  
2020  
  
2014  
  
2012  
King Edward Medical University Lahore   
  
BISE Lahore  
  
BISE Lahore   
Practical Experience (list all; with dates of employment):  
  
House surgeon – Ophthalmology ward unit II MHL (01-05-2020 to 31-07-2020)  
   
House surgeon – North surgical ward MHL ( 01-08-2020 to 31-10-2020)  
  
House physician – Pediatric ward unit II MHL (01-11-2020 to 31-01-2021)  
  
House physician – West medical ward MHL ( 01-02-2021 to 30-04-2021)  
  
  
  
 
 
 
 
 
Name of Parent Institution (if on Deputation):  
 
 
Name of Academic Supervisor / Principal Investigator:  
  
Prof Dr Ahmed Uzair Qureshi   
Signature:  
Date:  
Name of Co Supervisor / Co-Principal Investigator  
  
Signature:  
Date:  

Comparison of Extended Totally Extra peritoneal Repair (ETEP) and Subcutaneous OnLay 
Endoscopic Approach (SCOLA) for the treatment of Para umbilical Hernias (PUH) in terms of  
intraoperative factors and postoperative complications. 
 
Date of document: 18/12/2025 
Name of Chairman/ Head of Department  
  
Prof Dr Ahmed Uzair Qureshi  
  
Signature:  
Date:  
Name of Principal/ Dean  
  
  
Signature:  
  
  
Date:  
Convener, Institutional Review Board  
  
PROF. DR. SAQIB SAEED  
  
Signature:  
Date:  
Chairman (Advanced Studies & Research Board)  
  
  
                  
 Approved                               Not Approved  
  
  
  
  
  
  
  
                                               Vice Chancellor, KEMU  
Signature:   
Date:   
  
  
  
  
  
  
  
  
  
  
  

Comparison of Extended Totally Extra peritoneal Repair (ETEP) and Subcutaneous OnLay 
Endoscopic Approach (SCOLA) for the treatment of Para umbilical Hernias (PUH) in terms of  
intraoperative factors and postoperative complications. 
 
Date of document: 18/12/2025 
TITLE:  
Comparison of Extended Totally Extra peritoneal Repair (ETEP) and Subcutaneous OnLay 
Endoscopic Approach (SCOLA) for the treatment of Para umbilical Hernias (PUH) in terms 
of  intraoperative factors and postoperative complications. 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
  
 
  
  
  

Comparison of Extended Totally Extra peritoneal Repair (ETEP) and Subcutaneous OnLay 
Endoscopic Approach (SCOLA) for the treatment of Para umbilical Hernias (PUH) in terms of  
intraoperative factors and postoperative complications. 
 
Date of document: 18/12/2025 
 
  
 
  
INTRODUCTION:   
Para umbilical Hernias (PUH) are bulging of a part of intestine, peritoneal fat or omenta through 
the side of umbilicus. PUH are associated with  defective collagen, old age, smoking and high 
intra abdominal pressure such as coughing, prostatic symptoms, constipation, obesity and 
pregnancy. Short neck of hernial sac makes PUH more prone to be irreducible, obstructed and 
strangulated that leads to surgical treatment1. In the last decade of previous century treatment 
of PUH has evolved from traditionally open repair to minimally invasive surgery such as 
IPOM, PPOM, TAPP, MILOS, ETEP, SCOLA, and TARUP. MIS provides multiple benefits 
to patient as compared to open surgery like short hospital stay, decrease incidence of surgical 
site infection (SSI) and wound dehiscence2.  
ETEP (Extended Totally Extra Peritoneal) and SCOLA (Subcutaneous OnLay endoscopic 
Approach) are novel approaches in hernia repair. ETEP has been compared in multiple studies 
with IPOM where ETEP is showing promising results regarding postoperative pain and early 
return to activities. In ETEP Extra peritoneal working space and inexpensive polypropylene 
mesh placement is associated with decrease incidence of intraperitoneal complications and cost 
effective respectively. But ETEP has been associated with longer operative time(113minutes), 
steep learning curve and increased conversation rate to IPOM and open repair(10%)3-6.   
SCOLA repair was introduced to repair the hernias which were associated with divarication of 
recti.  As compared to the open repair SCOLA technique has provided good cosmetic results 
specially in those patients who were not ideal candidates for abdominoplasty. Dissection in 
subcutaneous tissue and preaponeurotic placement of mesh makes this technique more prone 
to SSI(6.3%) and seroma formation(25%)7,8.   
Till now there is no comparative study between SCOLA and ETEP. Most of studies previously 
done are either case based, descriptive or cohort1,2,4. Benefits of each technique need to be 
evaluated in terms of preoperative factors, intraoperative challenges and post-operative 
complications. If any one these technique proves better than the other then this study will guide 
the surgeons in training to focus on that technique.  
  
  
  
  

Comparison of Extended Totally Extra peritoneal Repair (ETEP) and Subcutaneous OnLay 
Endoscopic Approach (SCOLA) for the treatment of Para umbilical Hernias (PUH) in terms of  
intraoperative factors and postoperative complications. 
 
Date of document: 18/12/2025 
  
  
  
  
 
 
  
  
  
OBJECTIVES:  
The objective of this study is to compare the outcomes of  ETEP verses SCOLA in terms of 
preoperative factors,  intraoperative factors and post operative complications in patients with 
Para umbilical hernias(PUH).  
  
  
   
  
  
   
  
  
  
   
  
  
   
  
  
   
  

Comparison of Extended Totally Extra peritoneal Repair (ETEP) and Subcutaneous OnLay 
Endoscopic Approach (SCOLA) for the treatment of Para umbilical Hernias (PUH) in terms of  
intraoperative factors and postoperative complications. 
 
Date of document: 18/12/2025 
 
 
 
 
 
 
 
 
 
 
  
  
OPERATIONAL DEFINITIONS:  
       
      Intraoperative factors   
Intraoperative factors will include operative time, conversion to any other procedure, 
hernial contents and divarication of recti.  
Operative time  
Operative time will include time from the first incision to approximation of skin by skin 
stapler.  
Conversion to any other procedure  
If the operating surgeon has to shift the operative technique to IPOM or open hernia repair 
then this will be considered as conversion to any other procedure.  
Hernial contents  
Hernial contents will include fat, omentum or bowel.  
Divarication of recti  
An inter recti distance more than 2cm will be considered as diastasis of recti.  

Comparison of Extended Totally Extra peritoneal Repair (ETEP) and Subcutaneous OnLay 
Endoscopic Approach (SCOLA) for the treatment of Para umbilical Hernias (PUH) in terms of  
intraoperative factors and postoperative complications. 
 
Date of document: 18/12/2025 
     Postoperative complications  
Postoperative complications will include postoperative pain, rescue analgesia, Drain 
volume,  seroma and  surgical site infection.  
      Postoperative pain  
Postoperative pain will be assessed by the visual analogue score( 0-10) with zero showing 
no pain and 10 showing maximum pain. 
Rescue analgesia  
Rescue analgesia will include injection nalbuphine 3mg given for breakthrough pain. VAS 
score more than 4 will be considered as breakthrough pain. It will be measured as rescue 
analgesia given or not. 
 
Drain output   
Drain output will include amount and type of fluid (blood, serous, serosanginous,). Drains 
will be removed when drain out will be less than 25ml over 24h. Drain output more than 
100ml will be considered as high drain output and less than 100ml will be considered as 
low output. Drain out put will be measured as high  output or low output. 
      Seroma  
Collection of serous fluid at the operative site after hernia repair surgery within 30 days 
once the drains placed at the site of surgery would been out.  
Surgical site infections.    
If a Patient presents with hyperemia and pus discharge from wound within 30 days of 
operation requiring opening of wound or change in antibiotics will be labeled as surgical 
site infection. 
  
  
  
  
  
  
  
  

Comparison of Extended Totally Extra peritoneal Repair (ETEP) and Subcutaneous OnLay 
Endoscopic Approach (SCOLA) for the treatment of Para umbilical Hernias (PUH) in terms of  
intraoperative factors and postoperative complications. 
 
Date of document: 18/12/2025 
  
  
  
  
 
 
 
 
  
  
 
  
   
HYPOTHESIS:  
Extended Totally Extra peritoneal Repair (ETEP) is better than the Subcutaneous OnLay 
Endoscopic Approach (SCOLA) for the treatment of PUH in terms of  intraoperative factors 
and postoperative complications.  
  
  
 

Comparison of Extended Totally Extra peritoneal Repair (ETEP) and Subcutaneous OnLay 
Endoscopic Approach (SCOLA) for the treatment of Para umbilical Hernias (PUH) in terms of  
intraoperative factors and postoperative complications. 
 
Date of document: 18/12/2025 
MATERIAL AND METHODS:   
STUDY DESIGN:   
Randomized controlled trial.  
SETTING:   
The study will be conducted at the surgical floor in Mayo Hospital Lahore.  
DURATION OF STUDY:   
6 Months from the date of approval of synopsis  
SAMPLE SIZE:   
Sample size of 86 patients (43 patients in each group) is estimated by using 5% 
level of significance, 90% power of the test with expected percentage of seroma 
in ETEP as 3.3%3  and in SCOLA as 25%8.  
  
 
  
Z1-α = confidence level 95%   
Z1-β = power of the test 90%   
P1   = population proportion 1= 3.3%   
P2   = population proportion 2 = 25%  
  
 
 
 
  
SAMPLING TECHNIQUE:   
Non probability convenient sampling 

Comparison of Extended Totally Extra peritoneal Repair (ETEP) and Subcutaneous OnLay 
Endoscopic Approach (SCOLA) for the treatment of Para umbilical Hernias (PUH) in terms of  
intraoperative factors and postoperative complications. 
 
Date of document: 18/12/2025 
  
 
  
  
SAMPLE SELECTION:   
Inclusion Criteria:  
• 
Adults of  age group from 18 to 65 years  
• 
Patients of both gender admit with diagnosis of Para umbilical Hernias through outdoor 
department, documented on clinical examination by consultant general surgeon.  
Exclusion Criteria:  
• 
Patients with hernial defect more than 5cm, documented on peroperative findings  
• 
Patients with complicated hernias including irreducible and obstructed varieties, 
documented on clinical findings.  
• 
Patients who require abdominoplasty, opinion given by operative surgeon.  
• 
Patients with intermediate to high risk of MACE during the surgery, documented on 
fitness performa filled by cardiology team.   
• 
Patients with previous midline incision or laparotomy, documented on clinical 
examination.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Comparison of Extended Totally Extra peritoneal Repair (ETEP) and Subcutaneous OnLay 
Endoscopic Approach (SCOLA) for the treatment of Para umbilical Hernias (PUH) in terms of  
intraoperative factors and postoperative complications. 
 
Date of document: 18/12/2025 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
DATA COLLECTION PROCEDURE:  
 
All the patients who will fulfill the inclusion criteria will be admitted through OPD after taking 
their consent to be part of study. Risk to benefit ratio will be explained to them Preoperatively 
demographics of the patients including age, gender, BMI, hypertension, diabetes will be 
noted(CRF A). All the patient who fulfill inclusion criteria will be divided into two groups at 
the time surgery through lottery method. Group A and B will represent ETEP and SCOLA 
respectively.  
All the procedures will be performed by same surgical team.  
Intraoperative parameters including hernial content, hernial rent size, divarication of recti, 
operative time and conversion to any other technique of hernia repair will be noted by operating 
Surgeon.  
Postoperatively all the patients will be kept under observation for vitals derangement or 
hematoma formation or any primary bleeding complication . All the patients will be kept nil 
per oral for 6 hours . All the patients will be mobilized after 6 hours . Ringer lactate solution 1 
liter will be given once during the period of NPO.  Amoxicillin / Clavulanic acid 1.2g 
intravenous injection will be given three time a day for as many days as patient stay in ward. 
Injection ketorolac 30mg two times a day will be given for as many days as patient stays in 
ward. Rescue analgesia will be given as injection nalbuphine 3mg intravenous for breakthrough 
pain. Abdominal belt will be advised to all the patients postoperatively. 24h drain output will 
be monitored on the next day. All the patients will be discharged on the next day with oral 
antibiotics (Amoxicillin/ Clavulanic acid 1g two times a day), oral analgesic ( acetaminophen 
1g three times a day) for 7 days, abdominal belt and drains.  
All the patients will be called back for follow up visit at 3rd day, 7th day, 1st  month and at any 
day with complication for post operative pain, drain output, seroma formation and surgical site 
infection(CRF B).  
  

Comparison of Extended Totally Extra peritoneal Repair (ETEP) and Subcutaneous OnLay 
Endoscopic Approach (SCOLA) for the treatment of Para umbilical Hernias (PUH) in terms of  
intraoperative factors and postoperative complications. 
 
Date of document: 18/12/2025 
  
 
 
 
 
 
 
 
 
 
 
 
 
DATA ANALYSIS PRODECURE:  
 
The data will be analyzed by SPSS v26.0. Mean and standard deviation will he used for 
quantitative data and frequency and ratios will be used for qualitative data. Quantitative 
variables (Age, BMI, hernial rent size, operative time, VAS score, total rescue analgesia, drain 
volume) will be assessed by t-test. Qualitative variables( gender, diabetes, hypertension, 
operative technique, hernial contents, divarication of recti, seroma and SSI ) will be compared 
using chi-square test. P value < 0.05 will be considered as significant. 
  
  
  
 
  
  
  
  
  
  

Comparison of Extended Totally Extra peritoneal Repair (ETEP) and Subcutaneous OnLay 
Endoscopic Approach (SCOLA) for the treatment of Para umbilical Hernias (PUH) in terms of  
intraoperative factors and postoperative complications. 
 
Date of document: 18/12/2025 
  
  
  
  
  
  
  
  
  
 
  
  
  
  
  
OUTCOME & UTILIZATION:   
 
If any of these techniques proves better than the other then it will help the surgeons in 
training to focus on that technique for proper preoperative patients selection ,lesser 
number of postoperative complications.  
  
  
  
  
  
  
  
  
  

Comparison of Extended Totally Extra peritoneal Repair (ETEP) and Subcutaneous OnLay 
Endoscopic Approach (SCOLA) for the treatment of Para umbilical Hernias (PUH) in terms of  
intraoperative factors and postoperative complications. 
 
Date of document: 18/12/2025 
  
  
  
  
  
  
  
  
  
 
 
 
 
 
  
  
  
SCHEDULE/PHASING:   
 
  
 
 
Month  
 
 
  
1st  
2nd-3th  
4th   
5th   
6th    
Review literature   
  
  
  
  
  
Data collection  
  
  
  
  
  
Data Analysis  
  
  
  
  
  
Thesis writing  
  
  
  
  
  

Comparison of Extended Totally Extra peritoneal Repair (ETEP) and Subcutaneous OnLay 
Endoscopic Approach (SCOLA) for the treatment of Para umbilical Hernias (PUH) in terms of  
intraoperative factors and postoperative complications. 
 
Date of document: 18/12/2025 
Thesis submission  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
  
  
  
  
REFERENCES:   
1. O’Connell PR, McCaskie AW and Sayers RD. Bailey & Love’s short practice of surgery. 
28th ed. Boca Raton: CRC Press; 2023. P. 1073. 
2. Van Hoef S, Tollens T. Primary non-complicated midline ventral hernia: is laparoscopic 
IPOM still a reasonable approach?. Hernia. 2019;23(5):915-25. 
3. Jain M, Krishna A, Prakash O, Kumar S, Sagar R, Ramachandran R, et al. Comparison of 
extended totally extra peritoneal (eTEP) vs intra peritoneal onlay mesh (IPOM) repair 

Comparison of Extended Totally Extra peritoneal Repair (ETEP) and Subcutaneous OnLay 
Endoscopic Approach (SCOLA) for the treatment of Para umbilical Hernias (PUH) in terms of  
intraoperative factors and postoperative complications. 
 
Date of document: 18/12/2025 
for management of primary and incisional hernia in terms of early outcomes and cost 
effectiveness—a randomized controlled trial. Surg Endos. 2022;36(10):7494-502. 
4. Bellido Luque J, Gomez Rosado JC, Bellido Luque A, Gomez Menchero J, Suarez Grau 
JM, Sanchez Matamoros I, et al. Endoscopic retromuscular technique (eTEP) vs 
conventional laparoscopic ventral or incisional hernia repair with defect closure 
(IPOM+) for midline hernias. A case–control study. Hernia. 2021;25(4):1061-70. 
5. Kumar N, Palanisamy NV, Parthasarathi R, Sabnis SC, Nayak SK, Palanivelu C. A 
comparative prospective study of short-term outcomes of extended view totally 
extraperitoneal (e-TEP) repair versus laparoscopic intraperitoneal on lay mesh (IPOM) 
plus repair for ventral hernia. Surg Endosc. 2021;35(9):5072-7. 
6. Prakhar G, Parthasarathi R, Cumar B, Subbaiah R, Nalankilli VP, Praveen Raj P, et al. 
Extended view: totally extra peritoneal (e-TEP) approach for ventral and incisional 
hernia—early results from a single center. Surg Endosc. 2021;35(5):2005-13. 
7. Dong CT, Sreeramoju P, Pechman DM, Weithorn D, Camacho D, Malcher F. 
SubCutaneous OnLay endoscopic Approach (SCOLA) mesh repair for small midline 
ventral hernias with diastasis recti: An initial US experience. Surg Endosc. 
2021;35(12):6449-54. 
8. Claus C, Cavazzola L, Malcher F. SubCutaneous OnLay endoscopic Approach (SCOLA) 
for midline ventral hernias associated with diastasis recti. Hernia. 2021;25(4):957-62. 
 
 
 
 
  
  
 
 
 
 
  
 
  
                                                                                   Annexure I  

Comparison of Extended Totally Extra peritoneal Repair (ETEP) and Subcutaneous OnLay 
Endoscopic Approach (SCOLA) for the treatment of Para umbilical Hernias (PUH) in terms of  
intraoperative factors and postoperative complications. 
 
Date of document: 18/12/2025 
 
                CRF (A)                                           Day                       
Biodata  
Registration number                                                        Name       
Age                            Gender                                             Profession     
Inclusion criteria   
Patient’s age is between 18 year to 65 years and diagnosis of 
the patient is para umbilical hernia  
Yes  
No 
                                          
 Exclusion criteria   
  
Hernial defect is more than 5cm  
Yes  
No 
Patient’s hernia is of irreducible and obstructed variety  
Yes  
No 
Patient is a candidate of abdominoplasty 
Yes  
No 
Patient with high risk of MACE during surgery  
Yes  
No 
Patient with precious midline incision or laparotomy  
Yes  
No 
 
 
 
    
 Is patient giving consent                                  YES                        No      
  Alloted Group                                 Group A                                   Group B    
   
  
Preoperative variable  
                Value  
Age  
  
Gender  
  
BMI  
  
Diabetes   
  
Hypertension   
  
  

Comparison of Extended Totally Extra peritoneal Repair (ETEP) and Subcutaneous OnLay 
Endoscopic Approach (SCOLA) for the treatment of Para umbilical Hernias (PUH) in terms of  
intraoperative factors and postoperative complications. 
 
Date of document: 18/12/2025 
  
   
  
CRF (B)     
Date                                                                                                                           Day  
 
Registration number                                             Name  
Allocated group                           Group A                        Group B  
                                        Intraoperative and postoperative  variables  
  
Intraoperative Variables   Value  
Operative technique  
  
Hernial rent size   
  
Divarication of recti   
  
Contents of hernia  
Operative time  
  
Conversion  
to  
other 
technique  
  
  
Postoperative 
variables  
Day 0  
Day 1  
Day 3  
Day 7  
1 month  3  
month  
6  
month  
VAS score   
  
  
  
  
  
  
  
Total  
rescue 
analgesia   
  
  
  
  
  
  
  
Total  
drain 
volume  
  
  
  
  
  
  
  
Drain contents  
  
  
  
  
  
  
  
Seroma  
  
  
  
  
  
  
  
Surgical  
site 
infection  
  
  
  
  
  
  
  
  
  
  

Comparison of Extended Totally Extra peritoneal Repair (ETEP) and Subcutaneous OnLay 
Endoscopic Approach (SCOLA) for the treatment of Para umbilical Hernias (PUH) in terms of  
intraoperative factors and postoperative complications. 
 
Date of document: 18/12/2025 
  
  
 
 
 
 
 
 
  
                                                            ANNEXURE II                                                                             
                                                           Consent form  
 
  
 
  
 Comparison of Extended Totally Extraperitoneal Repair (ETEP) and 
Subcutaneous Onlay Endoscopic Approach (SCOLA) for the Treatment of 
Para-umbilical Hernias (PUH) in terms of intraoperative factors, 
postoperative complications, learning curve, patient satisfaction, and 
financial burden. 
I have been fully informed by my doctor about the complete details and the basic objectives 
of this research study. I have also been informed about the possible benefits and risks 
associated with participation in this research study. 
I understand that my participation in this research study is entirely voluntary, and that I may 
withdraw from the study at any time of my own free will without any penalty. In such a 
situation, my doctor will remain fully responsible for my complete medical treatment. 
I understand that my doctor or any person authorized by them may contact me at any time 
regarding this research study. I am also aware that all information provided by me will be 
kept confidential and will be used only for the purposes of this research study. 

Comparison of Extended Totally Extra peritoneal Repair (ETEP) and Subcutaneous OnLay 
Endoscopic Approach (SCOLA) for the treatment of Para umbilical Hernias (PUH) in terms of  
intraoperative factors and postoperative complications. 
 
Date of document: 18/12/2025 
By signing below, I indicate that I have read and understood the above information and 
voluntarily agree to participate in this research study. 
Participant’s Name: ______________________ 
Signature/Thumb Impression: ______________ 
Date: ______________________ 
Investigator’s Name: ______________________ 
Signature: