Single-Center Observational Study With Comparison of Endoscopic Extended-View Totally Extraperitoneal Prosthesis (eTEP) Versus Open Rives-Stoppa Repair as a Treatment of Midline Abdominal Wall Hernias With Rectus Diastasis
Conditions: Hernia, Ventral, Rectus Diastasis
Sponsor: AZ Alma

Single-Center Observational Study with Comparison of Endoscopic Extended-
View Totally Extraperitoneal Prosthesis (eTEP) Versus Open Rives-Stoppa Repair 
as a Treatment of Midline Abdominal Wall Hernias with Rectus Diastasis 
 
Study Protocol was composed according to the WHO data set [1] (version 1.3.1) and the SPIRIT 2013 
statement [2]. 
 
0.1 
Protocol additions 
Version 2:  
- 
Addition to participant flow (1.2.20) 
- 
Completion of entry to ClinicalTrials.gov. 
Version 3: Last updated December 26, 2022 
- 
Addition of ClinicalTrials.gov ID (1.1) 
- 
Addition to ‘actual sample size’ (1.2.14) 
- 
Addition to ‘recruitment status’ (1.2.15) 
- 
Addition of completion date (1.2.19) 
- 
Addition to participant flow and flowchart (1.2.20) 
- 
Additional registration to EHS-registry with addition to ‘baseline characteristics’ (1.2.20) 
- 
Correction of ‘adverse events’ under 1.2.20 since participant previously denoted with an adverse 
event exhibited exclusion criteria and was not included 
- 
Addition of ‘adverse events’ (1.2.20) 
- 
Addition of ‘brief summary’ (1.2.20) 
- 
Addition of ‘date of posting of results summaries’ (1.2.20) 
- 
Addition to IPD sharing statement (1.2.21) 
- 
Addition to ‘contributions’ (1.5) 
- 
Addition to ‘statistical analysis’ (3.1.9) 
 
1.1  Trial Registration 
ClinicalTrials.gov: 
- 
Date of Registration: June 24, 2022. 
- 
NCT05446675 
Secondary identifying number: EC/EH/220608-SK. 
 
1.2 
WHO Data Set   
1.2.1 Monetary or Material Support 
None. 
 
1.2.2  Primary Sponsor 

Department of Abdominal Surgery AZ Alma. 
Ringlaan 15, 9900 Eeklo, Belgium. 
 
1.2.3 Secondary Sponsors 
None. 
 
1.2.4  Contact for Public and Scientific Queries 
Dr. Sam Kinet, MD 
Trainee General Surgery, KU Leuven 
AZ Alma (general hospital), Ringlaan 15, 9900 Eeklo, Belgium 
Address: Ringlaan 15, 9900 Eeklo, Belgium 
Phone number: +32 (0)497 434 555 
E-mail: sam.kinet@a-kinetics.be 
ORCID: 0000-0001-7220-3489 
Twitter handle: @SamKinetMD. 
 
1.2.5  Public Title 
Endoscopic eTEP versus Open Rives-Stoppa. 
 
1.2.6 Scientific Title 
Single-Center Observational Study with Comparison of Endoscopic Extended-View Totally Extraperitoneal 
Prosthesis (eTEP) Versus Open Rives-Stoppa Repair as a Treatment of Midline Abdominal Wall Hernias 
with Rectus Diastasis. 
 
1.2.7 Countries of Recruitment 
Belgium. 
 
1.2.8 Health Conditions Studied 
Midline abdominal wall hernias alongside rectus abdominis diastasis. 
 
1.2.9 Interventions 

Group 1 (eTEP): Patients who underwent an endoscopic repair of their midline abdominal wall hernias and 
rectus diastasis via the extended-view totally extraperitoneal prosthesis method within our center. 
Group 2 (Rives-Stoppa, control group): Patients who underwent an open midline repair with sublay mesh 
according to the technique of Rives-Stoppa within our center. 
 
1.2.10  
Inclusion Criteria 
Group 1 (eTEP): 
- 
Patients who underwent an eTEP procedure in our center 
- 
Preoperative existence of one or more midline abdominal wall hernias 
- 
Preoperative existence of rectus abdominis diastasis 
 
Group 2 (Rives-Stoppa, control group): 
- 
Patients who underwent an open Rives-Stoppa (midline repair with sublay mesh) in our center 
 
1.2.11 
Exclusion Criteria 
Group 1 (eTEP): 
- 
Preoperative absence of midline abdominal wall hernias 
- 
Preoperative absence of rectus abdominis diastasis 
- 
Intraoperative performance of transverse abdominis release (TAR) 
- 
Intraoperative inguinal hernia repair 
 
Group 2 (Rives-Stoppa, control group): 
- 
Intraoperative performance of transverse abdominis release (TAR) 
- 
Intraoperative performance of anterior component separation 
- 
Intraoperative inguinal hernia repair 
 
1.2.12  
Study Type 
Single-center, observational study. 
Non-randomized allocation: 
- 
Group 1 (eTEP): First 30 patients who meet the inclusion criteria and do not exhibit any of the 
exclusion criteria will be investigated. The option for endoscopic eTEP repair, if feasible, is given 
preoperatively as a standard for the treatment of symptomatic midline abdominal wall hernias with 
concomitant rectus abdominis diastasis as an alternative to open Rives-Stoppa mesh repair. The 
modality of operative treatment is made in cooperation with the patient. 
 
- 
Group 2 (Rives-Stoppa, control): Thirty patients will be selected out of all patients who underwent an 
open Rives-Stoppa (midline repair with sublay mesh) in our center and who do not meet any of the 
exclusion criteria. Patient selection will consist of matching to patients in group 1 according to gender 
and age (e.g. a male patient in group 1 will be matched to a male patient (group 2) out of our records 

who underwent an open Rives-Stoppa repair and whose age most closely resembles the age of the 
matched patient in group 1). 
 
Masking: None. 
Assignment: Two-group, parallel. 
Purpose: Comparing two routinely used interventions for the treatment of midline abdominal wall hernias 
with rectus abdominis diastasis. 
 
1.2.13  
Date of First Enrollment 
June 9, 2022. 
 
1.2.14  
Sample Size 
Planned: 
- 
Group 1 (eTEP): 30 participants 
- 
Group 2 (Rives-Stoppa, control): 30 participants 
 
Actual: 
- 
Group 1 (eTEP): 30 participants 
- 
Group 2 (Rives-Stoppa, control): 30 participants 
 
1.2.15  
Recruitment Status 
Completed. 
 
1.2.16  
Primary Outcomes 
- 
Outcome name: Length of hospital stay 
Method of measurement: Time (days) spent within the hospital 
Timepoint: Start at day of operation (day zero) until day of discharge 
 
- 
Outcome name: Postoperative pain management 
Method of measurement: Modality (type, generic name), duration (days), dosage (grams or 
milligrams) and frequency (times per day) of analgesics administration  
Timepoint: During hospital stay 
 
1.2.17  
Secondary Outcomes 
- 
Outcome name: Intraoperative complications 
Method of measurement: Adverse event occurrence 
Timepoint: During surgery 

 
- 
Outcome name: Postoperative complications 
Method of measurement: Adverse event occurrence by readmission 
Timepoint: After discharge until 30 days postoperative 
 
1.2.18  
Ethics Review 
Ethics approval was granted on June 9, 2022, by the “Commissie voor Ethiek” at AZ Alma, after 
deliberation at their meeting on June 8, 2022. 
 
1.2.19  
Completion Date 
Planned: September 30, 2022. 
Actual: December 23, 2022. 
 
1.2.20  
Summary of Results 
Date of posting of results summaries: December 26, 2022 (within study protocol). 
Date of the first journal publication of results: Not yet achieved. 
URL: Not (yet) applicable. 
Baseline characteristics: 
- 
Group 1 (eTEP): EHS Registry: BEGZ, BEHA, BEHB, BEJR, BEJS, BEJT, BEJW, BEJX, BEJZ, 
BEKA, BEKB, BEKC, BEKG, BEKH, BEKI, BEKJ, BEKK, BEKL, BEKM, BELE, BELF, BELG, BELH, 
BELI, BELJ, BELK, BELL, BEOD, BETJ, BETK. 
- 
Group 2 (Open RS): EHS Registry: BELN, BELO, BELQ, BELR, BELS, BELT, BELU, BELV, BELW, 
BELY, BEOF, BEOH, BEOO, BEPV, BEPX, BEPY, BEPZ, BEQA, BEQF, BEQG, BEQJ, BEQK, 
BEQQ, BEQR, BEQS, BEQT, BEQV, BEQX, BETN, BETO. 
 
Participant flow (see also participant flowchart on next page):  
Date 
Group 1 
Group 2 
June 9, 2022 
23 participants 
23 participants 
June 13, 2022 
24 participants 
24 participants 
June 17, 2022 
25 participants 
25 participants 
June 20, 2022 
26 participants 
26 participants 
June 21, 2022 
27 participants 
27 participants 
July 11, 2022 
28 participants 
28 participants 
August 30, 2022 
30 participants 
30 participants 
 
 
 
 

Participant flowchart: 
 
 
 
Patients who underwent endoscopic eTEP at our 
center between September 2021 and August 2022: 
N = 40 
Patients included in the eTEP group: 
N = 30 
Patients excluded: 
 
N = 10 
Reasons for exclusion: 
• 
No rectus diastasis 
N = 3 
• 
TAR performed  
N = 4 
• 
No midline hernia 
N = 2 
• 
Inguinal hernia repair 
N = 1 
Patients from all Rives-Stoppa repairs in 
our center matched to patients in eTEP 
group according to gender and BMI: 
N = 30 
Patients excluded: 
 
N = 5 
Reasons for exclusion: 
• 
TAR performed  
N = 4 
• 
TAR performed  
+ no midline hernia 
N = 1 
Extra patients from all Rives-Stoppa repairs 
in our center matched to patients in eTEP 
group according to gender and BMI: 
N = 5 
Patients included in the open RS group: 
N = 30 
Total included patients: 
N = 60 

Adverse events: 
- 
Three conversions were needed in group 1 (eTEP) because no adequate visualization could be 
achieved (1 participant) or because the diastasis was deemed to large to be appropriately closed 
endoscopically (2 participants) 
- 
Observed complicationa according to the Clavien-Dindo (CD) classification [3]:  
During hospital stay in the eTEP group: 1x CD I, 12x CD II. 
During hospital stay in the Open RS group: 4x CD I, 10x CD II, 4x CD IIIb. 
After discharge until 30 days in the eTEP group: 5x CD I, 1x CD II, 2x CD IIIa, 1x CD IIIb. 
After discharge until 30 days in the Open RS group: 5x CD I, 1x CD II, 5x CD IIIa, 4x CD IIIb. 
 
Outcome measures: See brief summary. 
URL protocol files: Not applicable. 
Brief summary: 
- 
Median length of hospital stay was longer in the open RS group. 
- 
Median duration of patient-controlled analgesia was longer in the open RS group. 
- 
Switch to only oral analgesics took longer in the open RS group. 
- 
No significant difference in ‘comparable parameter’* for postoperatively administered analgesics 
irrespective of PCA between both groups. 
- 
No significant difference between the presence of prescription opioids at discharge. 
- 
Median duration of surgery (skin-to-skin time) was significantly shorter in the open RS group. 
- 
Need for drainage (postoperative drain inserted during primary surgery) was significantly greater in 
the open RS group. 
- 
No early recurrences were found in both groups (postoperative consultation at approximately one 
month after surgery). 
- 
Bulging of the abdominal midline was seen in 11 participants in the eTEP group and was not seen in 
the open RS group, this difference was statistically significant.  
 
*Comparable parameter: Types of analgesics were divided into three categories. Category 1 
contained only paracetamol, category 2 contained all non-steroidal anti-inflammatory drugs, and 
category 3 consisted of all opioids. A combination of active substances (in one analgesic) of which at 
least one was an opioid was seen as category 3. For each participant the absolute amount of 
analgesics in each category was calculated between postoperative day one and the day before 
discharge, this amount was divided by the amount of days between postoperative day one and the 
day before discharge.  
 
 
1.2.21  
IPD Sharing Statement 
IPD will be shared via the online EHS registry with contents adhering to their format. Accessible to all EHS 
members for all types of analyses. Currently shared: BEGZ, BEHA, BEHB, BEJR, BEJS, BEJT, BEJW, 
BEJX, BEJZ, BEKA, BEKB, BEKC, BEKG, BEKH, BEKI, BEKJ, BEKK, BEKL, BEKM, BELE, BELF, 
BELG, BELH, BELI, BELJ, BELK, BELL, BEOD, BETJ, BETK, BELN, BELO, BELQ, BELR, BELS, BELT, 
BELU, BELV, BELW, BELY, BEOF, BEOH, BEOO, BEPV, BEPX, BEPY, BEPZ, BEQA, BEQF, BEQG, 
BEQJ, BEQK, BEQQ, BEQR, BEQS, BEQT, BEQV, BEQX, BETN, BETO. 
 

1.3 
Protocol Version 
Protocol version 3, December 26, 2022. 
 
1.4 
Funding 
No finincial, material or other support. 
 
1.5 
Roles and Responsibilities 
- 
Contributor 1:  Dr. Sam Kinet, MD (CORRESPONDANCE) 
Trainee General Surgery (2nd year), KU Leuven 
AZ Alma (general hospital), Ringlaan 15, 9900 Eeklo, Belgium 
Address: Ringlaan 15, 9900 Eeklo, Belgium 
Phone number: +32 (0)497 434 555 
E-mail: sam.kinet@a-kinetics.be 
ORCID: 0000-0001-7220-3489 
Twitter handle: @SamKinetMD. 
 
- 
Contributor 2: Dr. Hendrik Maes, MD 
Attending physician Abdominal and General Surgery 
AZ Alma (general hospital), Ringlaan 15, 9900 Eeklo, Belgium 
 
- 
Contributor 3: Dr. Eddy FP Kuppens, MD 
Attending physician and chief Abdominal and General Surgery 
AZ Alma (general hospital), Ringlaan 15, 9900 Eeklo, Belgium 
 
- 
Contributor 4: Dr. Stijn Van Cleven, MD 
Attending physician Abdominal and General Surgery 
AZ Alma (general hospital), Ringlaan 15, 9900 Eeklo, Belgium 
 
Contributions: 
All contributors contributed to the study conception and design. Material preparation, data collection and 
analysis were performed by contributor 1. The study protocol and first draft of the manuscript were written 
by contributor 1 and all authors commented on previous versions of the study protocol and manuscript. 
Statistical analysis was performed by contributor 1 after consultation with a biostatistician. All contributors 
read and approved the final study protocol and manuscript. 
 
 
2.1 
Introduction 
2.1.1 Background and Rationale: 

Extended view totally extraperitoneal prosthesis (eTEP) repair is a fairly new, up-and-coming technique as 
a treatment option for ventral abdominal wall hernias. The endoscopic eTEP approach has been proven to 
be a feasible approach [4, 5]. Our center recently started offering this treatment option from September 7, 
2021 (first performance of the eTEP surgery within our center) onwards as a minimally invasive alternative 
to an open Rives-Stoppa [6] repair. A quick search revealed some comparisons of eTEP with IPOM [7], or 
comparisons between robotic and endoscopic eTEP [8], but little or no information could be found about 
comparisons between endoscopic (non-robot-assisted) eTEP and open Rives-Stoppa repair. Since the 
endoscopic eTEP repair and the open Rives-Stoppa repair both consist of a retromuscular mesh 
placement, and the endoscopic eTEP procedure is offered as a minimally invasive alternative to an open 
Rives-Stoppa repair in our center, an objective comparison between the two of them seemed logical. 
 
2.1.2 Objectives: 
To compare the outcomes of endoscopic eTEP repair versus open Rives-Stoppa repair in terms of length 
of hospital stay, postoperative pain management and complications. 
 
2.1.3 Trial Design: 
Partially retrospective, partially prospective, two-group, parallel, observational, superiority cohort study 
with an allocation ratio of 1:1. 
 
 
3.1 
Methods: Participants, Interventions and Outcomes 
3.1.1 Study setting 
AZ Alma Eeklo, general hospital. 
Country of data collection: Belgium. 
 
3.1.2 Eligibility criteria 
Inclusion and exclusion criteria for participants are listed under 1.2.10 and 1.2.11 respectively. AZ Alma 
Eeklo is the only eligible center. The eligible surgeons are those listed under 1.5 as contributor 2, 
contributor 3 and contributor 4.  
 
3.1.3 Interventions 
Explained under 1.2.9 and elaborated under 1.2.10, 1.2.11 and 1.2.12. All procedures were performed or 
will be performed by one of three surgeons listed under 1.5 as contributor 2, contributor 3 and contributor 
4. 
 
3.1.4  Outcomes 
Primary and secondary outcomes are listed under 1.2.16 and 1.2.17 respectively. 

3.1.5 Participant timeline 
See “Participant flow” under 1.2.20. 
 
3.1.6 Sample size 
Explained under 1.2.14. 
 
3.1.7 Recruitment 
No specific recruitment measures are undertaken. Participants are recruited retrospectively post-surgery, 
or, if possible at consultation when they present with eligible pathology and inclusion criteria. No difference 
to normal standard of care is made. From September 2021 onwards, the eTEP procedure was offered as 
an alternative to open Rives-Stoppa mesh repair for eligible participants. 
 
3.1.8 Methods: Assignment of interventions 
Not applicable (not a controlled trial). No sequence generation, allocation concealment or blinding were 
applied. Matching of the control group is elaborated under 1.2.12. Participants are enrolled by one of three 
surgeons listed under 1.5 as contributor 2, 3 and 4. Matching of participants and (retrospective) creation of 
the control (Rives-Stoppa) group is done by contributor 1.  
 
3.1.9 Methods: Data collection, management, and analysis 
Data collection is done by reviewing the electronic medical records of participants. No additional tests or 
interventions are undertaken other to those that are considered as standard of care. Collected data can be 
found in the EHS-registry as mentioned under 1.2.20 and 1.2.21. Additional data (if applicable) will be 
supplied within the final report. All relevant data regarding the outcome measures explained under 1.2.16 
and 1.2.17 will be collected for all enrolled participants. 
Uncoded data is entered and stored to files only accessible to members of the primary sponsor (1.2.2). 
Data quality will be regularly checked by contributor 1. 
A biostatistician was consulted for advice regarding statistical analysis. Statistical analysis was performed 
by contributor 1. JASP [9] was used for the majority of statistical analysis, Vassarstats [10] was used to 
calculate Fisher’s exact tests on 3 x 2 contingency tables, XLSTAT [11] was used to create Kaplan-Meier 
curves. 
 
3.1.10  
Methods: Data monitoring 
A specific data monitoring committee other than the primary sponsor was deemed irrelevant given the 
observational nature of the study. Interim results will only be available to the primary sponsor. No specific 
stopping guidelines are in effect. 
Adverse events are part of the secondary outcomes (1.2.17) and will be given within the final report. 
Unintended events will also be reported within the final manuscript. 

Auditing of intended trial conduct was assessed at ethics review during the meeting of “Commissie voor 
Ethiek” at AZ Alma on June 8, 2022. No further auditing is intended. 
 
4.1 
Ethics and Dissemination 
4.1.1  Research ethics approval 
As stated under 1.2.18, ethics approval was granted on June 9, 2022, by the “Commissie voor Ethiek” at 
AZ Alma, after deliberation at their meeting on June 8, 2022. 
 
4.1.2 Protocol amendments 
Amendments and complements are stated at the top of the protocol. Important protocol modifications (if 
applicable) will be separately communicated with all relevant parties. Final version of the protocol will be 
supplied to the journal at submission. 
 
4.1.3 Consent or assent  
Informed consent of all participants is obtained prior to surgery by one of the contributors listed under 1.5, 
and stored within the electronic medical record of the respective participant. Additional consent forms will 
be sent to all enrolled participants after achievement of final sample size.  
 
4.1.4 Confidentiality 
Uncoded data will only be accessible by the primary sponsor (1.2.2), which consists of the team of 
attending physicians. Only anonymised and relevant data will be available through the final manuscript 
and the EHS-registry as stated under 1.2.21.  Data collection, management and monitoring are explained 
under 3.1.9 and 3.1.10. 
 
4.1.5 Declaration of interest 
All contributors declare that they have no competing interests. No funding was acquired.  
 
4.1.6 Access to data 
Final study dataset will be available to the primary sponsor and relevant data will be supplied within the 
final manuscript. Anonymised relevant data is also available at the EHS-registry (see 1.2.20, 1.2.21 and 
4.1.4). Access is not limited to any contractual agreements. 
 
4.1.7 Ancillary and post-trial care 
Because both studied interventions are part of the standard of care, no specific additional care is foreseen 
or deemed applicable.  

4.1.8 Dissemination policy 
The primary sponsor and investigators/contributors plan to publish the results to a medical journal (title to 
be discussed). Data will also be available at the EHS-registry (see 1.2.20, 1.2.21, 4.1.4 and 4.1.6). 
All authors contributed to the study conception and design. Material preparation, data collection and 
analysis were performed by contributor 1 (see 1.5). The first draft of the manuscript will be written by 
contributor 1 and all authors/contributors will comment on previous versions of the manuscript. All 
authors/contributors will read and approve of the final manuscript. No intended use of professional writers. 
If allowed by the accepting journal, the study protocol will be made publicly available. Participant level 
dataset will be available (anonymized) at the EHS-registry as stated above. Statistical code is discussed 
under 3.1.9. 
 
5.1 Appendices 
5.1.1 Informed consent 
Translated version of the informed consent (original in Dutch) given to the participants prior to surgery. 
Point 6 is of particular interest to the conducted study. 
 
As a patient, you have the right to information about your condition and recommended surgical, 
medical and diagnostic procedures. You can only make a decision about undergoing a 
procedure/surgery if you have been sufficiently informed about the cost of the treatment, the 
purpose and risks of the treatment, the risks of not treating or delaying treatment, other treatment 
options and diagnostic investigations. This information is not intended to alarm you. The intention 
is to provide you with sufficient information, so that you can make a good decision whether or not 
you want to undergo the procedure/operation. You have the right to receive additional 
explanations from your doctor if you do not fully understand the information. 
 
1. The undersigned clearly declares that they do / do not (note 1) grant permission to the following 
surgery/procedure: (eTEP or open Rives-Stoppa). As a result, an admission and/or ambulatory 
procedure is foreseen at AZ Alma from / on: (date of admission / surgery). 
 
2. On (date of consultation prior to surgery) the doctor did / did not (note 1) give precise information 
about my state of health and about the diagnosis (midline abdominal wall hernia with rectus 
diastasis / other reason for Rives-Stoppa repair) that deemes this intervention/procedure 
necessary. They have explained to me the possible evolution if the above procedure is not 
followed, in simple and understandable terms. They also gave me information regarding other 
treatments/investigations, if any, with their pros and cons. They also explained to me the 
usefulness and effectiveness of the proposed treatment. 
 
3. The doctor did / didn't (note 1) clearly describe the nature and the intervention/procedure itself, 
any inconveniences that may result, as well as the risks and possible immediate and late 
complications. I have received oral and/or written explanations in this regard. I realize that most 
diagnostic, surgical or medical procedures can lead to inflammation, bleeding, blood clots 
(thrombosis) and allergic reactions. With regard to the planned procedure, I was also informed 
about other possible risks, in particular: (expanding care if necessary and acting on perioperative 
findings, possibility of conversion if eTEP). I also understand that medical clinical practice is not 

an exact science, that a list of possible complications can never be exhaustive and that no 
commitment/agreement can be made about the final outcome of the intervention/procedure. 
 
4. I was / wasn't (note 1) informed that during the intervention/procedure/admission, in case of 
unforeseen circumstances, the doctor may be forced to extend the intervention/procedure with 
additional treatments, different from those originally foreseen. In these circumstances, I authorize 
the physician to take any action he deems absolutely necessary to maintain or restore my state of 
health. (= DNR 0: apply full resuscitation procedure, as well as maximum therapeutic support) 
5. I do / do not (note 1) give permission to receive blood products if necessary. An information 
brochure is available for the patient (note 2). 
 
6. I do / do not (note 1) give permission to use all visual material, photos, body material and personal 
data that are taken or collected from me as a result of the intervention/procedure, and that are 
unrecognizable, for educational purposes, scientific research or processing in objective medical-
scientific information. 
 
7. I have / have not (note 1) been informed of an estimate of the financial costs associated with this 
type of treatment/procedure, in regard to to my personal requirements. I myself will inform about 
the extent of the intervention of my hospitalization insurance. 
 
8. I do / do not (note 1) give permission to the doctor mentioned below to perform the intervention or 
procedure in collaboration with a doctor or doctor-specialist in training of his/her choice. 
 
9. I did / didn't (note 1) have the opportunity to ask questions and the doctor answered them 
satisfactorily. I have understood the answers correctly. 
 
10. I declare that I have honestly informed the physician of my pre-existing health condition. 
 
I do / do not (note 1) give my consent for the abovementioned treatment/procedure to be carried out. 
Date: (date of signature). 
Signature of the patient or his legal representative, to be stated “read and approved”. 
Doctor's signature and stamp. 
 
Notes to the informed consent form: 
1. Cross out which one does not fit. 
2. If you do not agree with point 5 (blood transfusion), please complete the discharge form for 
patients who refuse a blood administration. 
3. For the storage of cells and tissue you must give permission on a separate form. 
4. The following appendices (description) are part of this document: (description of appendices if 
applicable). 
 
5.1.2 Biological specimens 
Not applicable. 
 

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