Evaluation of the New Veress Needle+ Mechanism; A Study on Thiel-embalmed Bodies.
Conditions: Pneumoperitoneum
Sponsor: Prof Jean Calleja-Agius

Amsterdam Skills Centre – Research Request Protocol – Template 2021 
 
TITLE: 
 
Principle Investigator 
 
Name: Roelf Postema MD 
Role: surgeon, PhD candidate 
Contact Details: r.r.postema@tudelft.nl 
Institutional affiliations: dept. of Surgery Amsterdam UMC, faculty of Biomedical Engineering 
TU Delft 
 
 
Other Investigators:  
 
Name: Tim Horeman-Franse MSc PhD 
Name: David Cefai MSc 
Role: assistant Professor-investigator 
Role: investigator 
Contact Details: t.horeman@tudelft.nl 
Contact Details: d.cefai@provinci-
medtech.com 
Institutional affiliations: faculty of Biomedical 
Engineering TU Delft 
Institutional affiliations: faculty of Biomedical 
Engineering TU Delft 
 
 
Name: Felix Nickel 
 
Role: surgeon-investigator 
 
Contact Details: Felix.Nickel@med.uni-
heidelberg.de 
 
Institutional affiliations: Dept. of Surgery 
Heidelberg University Medical Center Germany 
 
 
 
Date/Version: 29-3-2021 Vs. 2 
 
 
01-05-2021
Evaluation of the New Veress Needle+ Mechanism; A Pre-clinical Study on Thiel-embalmed Bodies.

Amsterdam Skills Centre – Research Request Protocol – Template 2021 
 
TABLE OF CONTENTS 
 
1. 
Background and significance ............................................................................................... 2 
2. 
Study objective(s): ................................................................................................................ 2 
3. 
Methods ............................................................................................................................... 2 
4. 
Data collection and analysis ................................................................................................ 3 
5. 
Data and study record management .................................................................................. 3 
6. 
Study Limitations .................................................................................................................. 3 
7. 
Ethical Considerations ......................................................................................................... 3 
8. 
Plans for dissemination of findings ..................................................................................... 4 
 
 
 
01-05-2021
Evaluation of the New Veress Needle+ Mechanism; A Pre-clinical Study on Thiel-embalmed Bodies.

Amsterdam Skills Centre – Research Request Protocol – Template 2021 
1. Background and significance  
Complications that occur in laparoscopic surgery are often associated with the 
initial entry into the peritoneal cavity. The literature reported incidences of Veress 
Needle (VN) injuries of e.g. 0.31% and 0.23% . In a 2010 national survey of 
laparoscopic entry techniques in the Canadian General Surgical practice, 57.3% of 
respondents had either experienced or witnessed a serious laparoscopic entry 
complication like bowel perforation and vascular injury. As those complications are 
potentially life threatening and should be avoided at all costs, improving safety of 
this initial action is paramount.  
Based on a bare minimum design approach with focus on function expansion of 
existing components, a new Safety mechanism was developed for the VN that 
decreases the risks of VN overshooting. The mechanism works by preventing the 
puncturing acceleration of the tip of the VN by decoupling the surgeon’s hand from 
the VN immediately after entering the abdomen.  
A first prototype of our so called VN+ with force decoupling mechanism proved 
very reliable in reducing overshooting in an ex-vivo model. 
2. Study objective(s):  
The purpose of the study is to repeat our previous ex-vivo experiments in a real-life 
laparoscopic set up in a human/cadaveric model.  
The primary objective will be to establish what the amount of benefit will be in 
using the VN+ as compared to a standard VN. We need to measure in a life-like 
situation what the reduction of the overshoot will be while in the hands of novices, 
junior residents and experts to validate the learning curve. Other secondary 
objectives are establishing the amount of haptic feedback of the VN+ compared to 
the standard VN and potential safety issues. All the practical investigations will 
need to take place in the ASC. Data study and technical alterations on the 
instruments will take place at the TU Delft.  
3. Methods 
 
3.1 Study design, population and procedures 
Study design: open randomized controlled prospective cross over cohort study  
Study population: A) group of 10 novices, B) group of 10 surgical, urological or 
gynaecological residents, C) group of 10 experts consisting of surgeons, urologists 
or gynaecologists. 
Study procedure: After information is given on the purpose and set up of the 
experiment all participants will be asked to sign an informed consent form. 
A video will be shown of the working of a normal VN and of the VN+. After this a 
detailed video will be shown wherein all basic steps of the procedure are outlined. 
Then after randomization half of the group will start with a VN and the other half 
with the VN+. After 5 attempts the groups will switch device and repeat the 
procedure.  
 
3.2 Procedure and anatomical considerations 
After making a small skin incision the insertion of the Veress needles will be: 
- at Palmer’s point which is 2-3 cm below the left costal margin in the midclavicular 
line. 
- right below the umbilicus after lifting the skin with a clamp 
01-05-2021
Evaluation of the New Veress Needle+ Mechanism; A Pre-clinical Study on Thiel-embalmed Bodies.

Amsterdam Skills Centre – Research Request Protocol – Template 2021 
A “grid” will be drawn on the skin. Guided by the grid each attempt will be in a new 
and unused part of the abdominal wall.  
As in total 300 VN(+) insertions have to be performed we will probably need three 
cadavers 
 
The anatomical region to be used will thus be the abdomen. 
In order to see what depth the different needles reach and the possible anatomical 
structures that will be injured, we will first introduce a laparoscope in the left (or 
depending on the cadaver the right) lower abdominal quadrant via an open 
technique and establish pneumoperitoneum through this laparoscope trocar with 
a pressure that is as low as possible.  
Then measurements will take place through recording the number of marks on the 
needle (previously laser engraved) that are to be seen in the abdomen. The actions 
will all be filmed and photographed.  
4. Data collection and analysis 
In all three groups the measured maximum insertion depths will be calculated in Excel 
and then any differences between the conventional (VN) and the modified (VN+) 
groups will be determined with a Mann-Whitney test (SPSS v16, SPSS inc. Chicago, IL) 
as the data will not be normally distributed. A p-value<0.05 will be considered 
significant. 
All inadvertent tissue or organ damage will be determined and compared between the 
two types of needles and the groups using a Student T-test (SPSS v16, SPSS inc. 
Chicago, IL). 
A questionnaire (with a Likert scale) will be used to establish the amount of haptic 
feedback the subjects experience with either the VN or the VN+ at the two different 
entry sites.  
5. Data and study record management 
Data and video footage will be stored on a secured TU Delft laptop and designated 
secured part of the 3ME faculty TU Delft server. All personal information of individuals 
taking part in this study will be anonymized.  
6. Study Limitations  
Limitations: 
- different tissue volume and elasticity compared to living tissue 
- intraabdominal organs will not react the same way as in living human being 
- to be able to determine depth of insertion a small pneumoperitoneum has to be 
created which in real life situations will not be the case 
7. Ethical Considerations  
If the VN+ really does make a significant difference in safety of VN insertion its use will 
lead to a worldwide reduction in morbidity and mortality caused by VN insertion. A 
pilot study in an ex-vivo animal (pig) model showed significant positive results. In order 
to take the step to clinical implementation experiments on human tissue are 
paramount.  
01-05-2021
Evaluation of the New Veress Needle+ Mechanism; A Pre-clinical Study on Thiel-embalmed Bodies.

Amsterdam Skills Centre – Research Request Protocol – Template 2021 
8.  Plans for dissemination of findings 
The results of this study will be disseminated to a clinical scientific audience through 
publishing in peer reviewed clinical surgical journals and participation in relevant 
international congresses and symposia. 
Adequate references to our use of the specimens and associated anatomy 
departments will be given.  
 
 
 
01-05-2021
Evaluation of the New Veress Needle+ Mechanism; A Pre-clinical Study on Thiel-embalmed Bodies.

Amsterdam Skills Centre – Research Request Protocol – Template 2021 
The following protocol will be presented to an ethics committee. This 
committee comprises of a professor in medical ethics, a professor in 
anatomy, two legal councils and two surgeons. Based on your answers 
provided, a decision will be made as to whether the proposed research can 
take place on human specimens, derived from the Dutch body donation 
program, within the Amsterdam Skills Centre. Once a decision has been 
reached, we will notify you of the outcome and provide you with a cost 
estimate.  
 
01-05-2021
Evaluation of the New Veress Needle+ Mechanism; A Pre-clinical Study on Thiel-embalmed Bodies.