Pilot Study of SuperSeton Placement in Patients With Perianal Fistulas
Phase: NA
Conditions: Perianal Fistula, Perianal Crohn Disease
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Version 4 – May 16th 2017                        The SuperSeton Pilot Study  
 
 
 
 
 
 
 
 
 
STUDY PROTOCOL 
 
 
 
Pilot Study of SuperSeton Placement in Patients with 
Perianal Fistulas 
 
 
The SuperSeton Feasibility Study 
 
 
 
 
 

Version 4 – May 16th 2017                        The SuperSeton Pilot Study  
 
 
 
 
 
PROTOCOL TITLE: 
Feasibility Study of SuperSeton Placement in Patients with Perianal Fistulas 
Short title 
The SuperSeton Feasibility Study 
Acronym 
The SuperSeton Feasibility Study 
 
Version 
4 
Date 
16-05-2017 
Coordinating investigator/project 
leader 
 
Prof. dr. W.A. Bemelman 
  
 
dept. of Surgery 
Academic Medical Center 
Department of Surgery, G4-111  
PO Box 22660 
1100 DD Amsterdam 
The Netherlands 
Telephone: +31-20-5666818 
Fax: +31-20-5666569  
E-mail: w.a.bemelman@amc.uva.nl 
Principal investigator(s) (in Dutch: 
hoofdonderzoeker/uitvoerder) 
 
Prof. dr. WA Bemelman, dept. of Surgery, AMC 
Dr. CJ Buskens, dept. of Surgery, AMC 
 
 
Research residents: 
Drs. ME Stellingwerf, dept. of Surgery & Gastroenterology 
AMC 
Independent physician(s) 
Dr. MGH Besselink 
dept. of Surgery, AMC 
 
E-mail: m.g.besselink@amc.uva.nl 
 
Tel: 020- 5662558 
 

Version 4 – May 16th 2017                        The SuperSeton Pilot Study  
 
 
 
 
 
PROTOCOL SIGNATURE SHEET 
 
Name 
Signature 
Date 
Head of Department: 
 
Prof. dr. DA Legemate 
Surgeon, Head of Surgery Department 
 
 
Coordinating Investigator/Project 
leader/Principal Investigator: 
 
Prof. dr. WA Bemelman 
Surgeon 
 
 
 
 
 
 

Version 4 – May 16th 2017                        The SuperSeton Pilot Study  
 
 
 
 
 
TABLE OF CONTENTS 
 
INTRODUCTION AND RATIONALE ................................................................................................. 8 
1.1 
Introduction & rationale ......................................................................................................... 8 
2. 
OBJECTIVES ............................................................................................................................ 9 
3. 
STUDY DESIGN ..................................................................................................................... 10 
4. 
STUDY POPULATION........................................................................................................... 11 
4.1 
Population (base) ................................................................................................................. 11 
4.2 
Inclusion criteria .................................................................................................................. 11 
4.3 
Exclusion criteria ................................................................................................................. 11 
4.4 
Sample size calculation ........................................................................................................ 11 
5. 
TREATMENT OF SUBJECTS ................................................................................................ 12 
5.1 
Investigational product/treatment ........................................................................................ 12 
6. 
METHODS ............................................................................................................................... 13 
6.1 
Study parameters/endpoints ................................................................................................. 13 
6.1.1 
Main study parameter/endpoint ..................................................................................... 13 
6.1.2 
Secondary study parameters/endpoints (if applicable) .................................................. 13 
6.2 
Study procedures .................................................................................................................. 13 
6.3 
Questionnaires ...................................................................................................................... 13 
6.4 
Withdrawal of individual subjects ....................................................................................... 13 
6.5 
Section 10 WMO event ........................................................................................................ 13 
6.6 
Adverse and serious adverse events ..................................................................................... 14 
6.6.1 
Suspected unexpected serious adverse reactions (SUSAR) .......................................... 15 
6.7 
Follow-up of adverse events ................................................................................................ 15 
6.8 
Data and safety monitoring and Data Safety Monitoring Board (DSMB) ........................... 15 
STATISTICAL ANALYSIS ................................................................................................................. 15 
6.9 
Statistics ............................................................................................................................... 16 
7. 
ETHICAL CONSIDERATIONS ............................................................................................. 17 
7.1 
Regulation statement ............................................................................................................ 17 
7.2 
Recruitment and consent ...................................................................................................... 17 
7.3 
Objection by minors or incapacitated subjects (if applicable) ............................................. 17 
7.4 
Compensation for injury ...................................................................................................... 17 
7.5 
Incentives (if applicable) ...................................................................................................... 18 
7.6 
Handling and storage of data and documents ...................................................................... 18 
7.7 
Monitoring ........................................................................................................................... 18 
7.8 
Amendments ........................................................................................................................ 18 
7.9 
Annual safety report ............................................................................................................. 18 

Version 4 – May 16th 2017                        The SuperSeton Pilot Study  
 
 
 
 
 
7.10 
End of study report ............................................................................................................... 19 
7.11 
Public disclosure and publication policy ............................................................................. 19 
9. 
TIME SCHEDULE .................................................................................................................. 20 
10. 
REFERENCES ......................................................................................................................... 21 
11. 
APPENDIX ................................................................................................................................ 2 

Version 4 – May 16th 2017                        The SuperSeton Pilot Study  
 
 
 
 
6 of 22 
LIST OF ABBREVIATIONS AND RELEVANT DEFINITIONS 
 
ABR 
ABR form (General Assessment and Registration form) is the application form that 
is required for submission to the accredited Ethics Committee (ABR = Algemene 
Beoordeling en Registratie) 
AE 
Adverse Event 
AR 
Adverse Reaction 
CA 
Competent Authority 
CCMO 
Central Committee on Research Involving Human Subjects 
CV 
Curriculum Vitae 
DSMB 
Data Safety Monitoring Board 
EU 
European Union 
EudraCT European drug regulatory affairs Clinical Trials GCP Good Clinical Practice 
IB 
Investigator’s Brochure 
IC 
Informed Consent 
IMP 
Investigational Medicinal Product  
IMPD 
Investigational Medicinal Product Dossier  
METC  
Medical research ethics committee (MREC); in Dutch: medisch ethische toetsing 
commissie (METC) 
(S)AE 
Serious Adverse Event  
SPC 
Summary of Product Characteristics (in Dutch: officiële productinformatie IB1-
tekst) 
Sponsor 
The sponsor is the party that commissions the organisation or performance of the 
research, for example a pharmaceutical 
company, academic hospital, scientific organisation or investigator. A party that 
provides funding for a study but does not commission it is not regarded as the 
sponsor, but referred to as a subsidising party. 
SUSAR 
Suspected Unexpected Serious Adverse Reaction 
Wbp 
Personal Data Protection Act (in Dutch: Wet Bescherming Persoonsgevens) 
WMO 
Medical Research Involving Human Subjects Act (Wet Medisch-wetenschappelijk 
Onderzoek met Mensen 
 
 

Version 4 – May 16th 2017                        The SuperSeton Pilot Study  
 
 
 
 
7 of 22 
SUMMARY 
Rationale: Perianal fistulas are a common incapacitating problem. Many patients are treated by seton 
drainage to prevent recurrent abscess formation. Nowadays, vessel loops or sutures are used for 
drainage. The knot of these seton drains can cause complaints of pain or tenderness if it presses against 
the external opening of the fistula or even slides in to the fistula tract. Medishield B.V. designed a 
knotless seton drain, the SuperSeton. This could decrease the pain complaints caused by the knot. 
Objective: With this study we aim to determine the feasibility of SuperSeton placement in patients 
with perianal fistulas. 
Study design: The design of the study is a feasibility study. 
Study population: Patients (≥ 18 years) with perianal fistulas (ever) treated with a knotted seton are 
eligible. 
Intervention: The SuperSeton will be placed at the outpatient clinic in patients that already have a 
seton in situ. This seton will then be exchanged by the SuperSeton. In case patients do not have a seton 
in situ, the SuperSeton can be placed at the operating theatre in day care setting instead of a regular 
seton. 
Main study parameters/endpoints: The primary outcome is seton failure (loosening of the seton). 
Secondary outcomes are time of procedure, complications and quality of life measured by the PDAI 
(‘Perianal Disease Activity Index’). 
Nature and extent of the burden and risks associated with participation: The SuperSeton will be 
placed in patients with perianal fistulas (ever) treated with a conventional knotted seton. There are no 
additional risks involved. The seton will be placed at the outpatient clinic in patients with a seton in 
situ, or at the operating theatre in day care setting in patients with a perianal abscess without a seton. 
The material that is used for the Setons is of medical grade polyurethane, this is the same material of 
catheters that are already used in clinical practice (instech BTPU 027). The Setons including the insert 
(BTPU) are supplied sterile (Synergy Health). Sample size calculation: A group of 60 patients will be 
included to determine feasibility of the SuperSeton. The proposed treatment protocol is considered 
feasible if at least 70% of the SuperSetons stay in place. 
 
PARTICIPATING CENTRES 
 
 
 
 
 
 
Surgeon 
 
 
Academic Medical Center 
 
Prof. dr. W.A. Bemelman 
 
 
 
 
 
Dr. C.J Buskens 
 
Proctos Kliniek 
 
 
 
Drs. C.B.H. Molenaar 

Version 4 – May 16th 2017                        The SuperSeton Pilot Study  
 
 
 
 
8 of 22 
 
INTRODUCTION AND RATIONALE 
 
1.1 Introduction & rationale 
Perianal fistulising disease is associated with local pain, discharge, and considerable morbidity 
rates (including sphincter and perineal tissue destruction) resulting in a negative impact on quality of 
life.1 The main cause of perianal fistula development is sepsis originating from the cryptoglandular 
glands.2 Other aetiologies are Crohn’s disease (CD), malignancies, radiation, trauma or foreign bodies. 
In simple or low fistulas (lower one-third of the external sphincter) treatment consists of lay open 
techniques and recurrences are hardly seen. 
 
In contrast, complex or high perianal fistulas (upper two-third of the external sphincter) have 
limited treatment options. The most frequently used treatment approach has been surgical non-cutting 
seton placement for chronic drainage of the fistula. This technique dates back to the ancient times. A 
seton maintains patency of the tract and eliminates the accumulation of pus which prevents the 
recurrent formation of tracts and abscesses. In addition, fibrosis of the fistula tract can be achieved. 
However, the seton has been reported to negatively influence quality of life and is associated 
with a decreased Perianal Disease Activity Index (PDAI score).3 Closure rates after seton removal 
vary widely in patients with CD (13.6%-100%).4 Nowadays, vessel loops or sutures are used as seton 
to drain the fistula. The ends of the seton drain are connected by a knot or a suture according to known 
methods. A knotted seton is relatively difficult to clean, and the knot has a tendency to rotate towards 
the external opening of the fistula tract and sometimes even migrate in to the fistula tract. This may 
cause complaints of pain and discomfort. This matter is widely discussed on patient forums. Last year, 
a survey regarding complaints of the knot of the seton, was send via the website of the CCUVN 
(Crohn en Colitis Ulcerosa Vereniging Nederland) to patients with perianal fistulas. This survey 
showed that complaints varied from irritation, discharge of blood and/or pus, pain and itching. Sitting 
and bicycling were mentioned as activities that aggravated the symptoms. Up till now one other 
knotless seton is available, the Comfort Drain.5 
Recently, MediShield B.V. developed a knotless seton, the ‘SuperSeton’. This seton connects 
the two ends of the drain to form a smooth closed loop. It is expected that this smooth joint will 
decrease pain and discomfort in patients with perianal fistulas that are treated by seton drainage. In 
addition, the SuperSeton can make placement of the seton less complex for the surgeon. 
With this study we will be able to comment on the feasibility of the SuperSeton.  
 
 
 
 

Version 4 – May 16th 2017                        The SuperSeton Pilot Study  
 
 
 
 
9 of 22 
2. OBJECTIVES 
 
With this study we aim to determine the feasibility of SuperSeton placement in patients with perianal 
fistulas. 
 
Primary Objective:  
The primary objective of this study is to determine feasibility of the SuperSeton drain.  
 
Secondary Objectives: 
Secondary outcomes are time of procedure, complications and quality of life measured by the PDAI 
(‘Perianal Disease Activity Index’). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Version 4 – May 16th 2017                        The SuperSeton Pilot Study  
 
 
 
 
10 of 22 
3. STUDY DESIGN 
 
The design of the study is a feasibility study with SuperSeton placement in patients with perianal 
fistulas. The trial will be conducted in the AMC and the Proctos Kliniek. Patients fulfilling the 
inclusion criteria without any exclusion criteria will be included in the study. The total inclusion is 
scheduled to take place within 10 months. 
 
Patients will be seen at the outpatient clinic 3 months after SuperSeton placement by 
the surgeon. Other visits will be scheduled on indication. During these contacts the PDAI score 
will be assessed. Patients will be followed by the research resident to assess complications or 
re-admissions.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Version 4 – May 16th 2017                        The SuperSeton Pilot Study  
 
 
 
 
11 of 22 
 
4. STUDY POPULATION 
 
4.1 Population (base)  
Patients with a perianal fistula for which a seton was already placed in day care setting (that is still in 
situ) and patients presenting with a recurrent perianal fistula (ever treated with a knotted seton) for 
which a new seton will be placed are eligible.  
 
4.2 Inclusion criteria 
-  ≥ 18 years 
- Written informed consent 
-  Perianal fistula with a seton in situ or a recurrent perianal fistula for which a new seton will be 
placed 
 
4.3 Exclusion criteria 
-  Patients with a pacemaker or an ICD in situ 
-  Rectovaginal fistula 
- Patients with a stoma 
- Life expectancy < 2 years 
-  The inability of reading/understanding and filling in the questionnaires 
-  Dementia or altered mental status that would prohibit the understanding and giving of informed  
   consent 
- Participation in another trial 
 
4.4 Sample size calculation 
The sample size calculation is based on a clinically relevant decrease in the PDAI and number of re-
interventions. The PDAI has 5 items, subdivided in a 5-point Likert scale (range 0-20). A score of >7 
is considered as serious perianal disease. The CCUVN survey indicated that the PDAI reflected severe 
complaints in Crohn’s fistula patients, with high scores on all 5 scales (average 9.2). A decrease to 6.9 
is considered to be clinically relevant (<7 considered as moderate perianal complaints). In the survey it 
also became apparent that 50% required re-interventions related to the knot. Reducing the 50% of 
reinterventions to 30% is considered clinically important and can be expected due to the stronger 
insert connection and less knot-related complaints.  
 
The sample size needed to demonstrate superiority of the SuperSeton with a significant decrease in 
PDAI and number of re-interventions is 60 patients (alpha 0.05, power 90%, and 5% drop-out).  
Feasibility:  

Version 4 – May 16th 2017                        The SuperSeton Pilot Study  
 
 
 
 
12 of 22 
The proposed treatment protocol is considered feasible if at least 70% of  the SuperSetons  stay in 
place. 
 
 
5. TREATMENT OF SUBJECTS 
 
5.1 Investigational product/treatment 
Patients with an established perianal fistula and a seton in situ or for which a new seton will be placed 
will be included in the study. 
All patients start with the placement of the SuperSeton at the outpatient clinic or at the operating 
theatre in day care setting. The flow chart is demonstrated in the attached figure 1 (Appendix). After 3 
months, the feasibility of the SuperSeton will be assessed. 
The SuperSeton is made of medical grade Polyurethaan, which is widely already used in 
clinical practice as catheters (instech BTPU 027). The setons including the insert (BTPU) are delivered 
sterile (Synergy Health).Therefore, there is no additional risk associated with SuperSeton placement. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Version 4 – May 16th 2017                        The SuperSeton Pilot Study  
 
 
 
 
13 of 22 
6. METHODS 
 
6.1 Study parameters/endpoints 
6.1.1 Main study parameter/endpoint 
- 
The primary outcome is seton failure (loosening of the seton) 
 
6.1.2 Secondary study parameters/endpoints (if applicable) 
- Procedure time 
- Complications 
- Disease activity and quality of life, as measured with the Perianal Disease Activity Index (PDAI) 
score 
 
6.2 Study procedures 
Informed consent will be obtained at the outpatient department in all eligible patients by the study team. 
Seton replacement will be performed at the outpatient clinic and new setons will be placed at the 
operating theatre in day care setting. 
 All patients will be followed for 3 months by the study team. 
The flow chart is provided in the attached figure 1 (Appendix). 
 
Patients will be contacted by telephone after ± 3 months the study coordinator to assess 
complications, additional interventions, re-admissions, duration of hospital stay and visits to the 
outpatient clinic.  
 
6.3 Questionnaires 
The following questionnaire will be used: 
PDAI score: The Perianal Disease Activity Index (PDAI) is the gold standard for evaluating the 
severity of perianal disease. It includes five items: discharge, pain, restriction of sexual activity, type of 
perianal disease, and degree of induration. Each category is graded on a 5-point Likert scale ranging 
from no symptoms to severe symptoms.  
 
6.4 Withdrawal of individual subjects 
Patients can leave the study at any time for any reason if they wish to do so without any consequences. 
The investigator can decide to withdraw a subject from the study for urgent medical reasons. 
 
SAFETY REPORTING 
 
6.5 Section 10 WMO event 
In accordance to section 10, subsection 4, of the WMO, the sponsor will suspend the study if there is 
sufficient ground that continuation of the study will jeopardise subject health or safety.  The sponsor 

Version 4 – May 16th 2017                        The SuperSeton Pilot Study  
 
 
 
 
14 of 22 
will notify the accredited METC without undue delay of a temporary halt including the reason for such 
an action. The study will be suspended pending a further positive decision by the accredited METC. 
The investigator will take care that all subjects are kept informed.  
 
 
6.6 Adverse and serious adverse events 
Adverse events are defined as any undesirable experience occurring to a subject during a 
clinical trial, whether or not considered related to the investigational procedure. All adverse 
events reported spontaneously by the subject, or observed by the investigator or his staff will 
be recorded. 
A serious adverse event is any untoward medical occurrence or effect that  
 
- results in death; 
- is life threatening (at the time of the event); 
- requires hospitalisation  
- results in persistent or significant disability or incapacity; 
- is a new event of the study likely to affect the safety of the subjects, such as an unexpected  
outcome of an adverse reaction, lack of efficacy of an IMP used for the treatment of a life  
threatening disease, major safety finding from a newly completed animal study, etc. 
 
An adverse reaction (AR) is an untoward and unintended response to the investigational 
product(s) related to any dose administered. 
A suspected serious adverse reaction (SSAR) is a serious adverse reaction, of which the 
nature, or severity, is consistent with the applicable product information i.e. the summary of 
the product characteristics. 
A suspected unexpected serious adverse reaction (SUSAR) is a serious adverse reaction, of 
which the nature, or severity, is not consistent with the applicable product information i.e. the 
summary of the product characteristics. 
 
Reporting procedure applies to all (S)AE's occurring from the time a subject gives consent 
until 30 days after the last study medication administration and to any SAE that occurs after 
the 30-day period, if it is considered to have a reasonable possibility to be related to the 
protocol treatment or study participation.  
A life threatening SAE, or SAE with death as a result, must be reported within 7 days 
after the local investigator has been informed. Other SAEs must be reported within 15 days. 

Version 4 – May 16th 2017                        The SuperSeton Pilot Study  
 
 
 
 
15 of 22 
The study coordinator is responsible for reporting SAEs at CCMO module ‘ToetsingOnline’. 
Using the CCMO module ‘ToetsingOnline’, all SAEs will be reported to the CCMO and 
central METC. By means of this website notifications will be sent to the relevant authorities 
(METC/LAREB/EudraVigilance). The reporting will occur within 15 days after the 
investigator has first received information on the SAE. For fatal or life-threatening cases a 
preliminary report will be offered within 7 days followed by a complete report within 8 days.  
 
The following SAE’s do not require immediate reporting but will be reported once yearly in 
line-listings to the accredited METC that approved the protocol: 
- 
Elective hospitalization for pre-existing conditions that have not  been exacerbated by trial 
treatment 
- 
A hospitalization which was planned before the subject consented for study participation 
and where admission did not take longer than  anticipated 
- 
Social and/or convenience admission to a hospital 
- 
Disease recurrence in the follow-up period requiring hospitalisation 
 
6.6.1 Suspected unexpected serious adverse reactions (SUSAR) 
SUSARs will be electronically reported via ToetsingOnline and the trial coordinator will communicate 
all SUSARs to the independent monitor and to the steering committee (WA Bemelman and CJ 
Buskens) of this study. 
 
6.7 Follow-up of adverse events 
All adverse events will be followed until they have abated, or until a stable situation has been reached. 
Depending on the event, follow up may require additional tests or medical procedures as indicated, 
and or referral to the general physician or a medical specialist. 
 
6.8 Data and safety monitoring and Data Safety Monitoring Board (DSMB) 
This study is considered a low risk trial. Therefore no DSMB will be installed. The AMC study 
coordinator will monitor the data.  
 
Furthermore, to keep insights in SAE’s, the trial coordinator will communicate all SAE’s to the the 
steering committee (WA Bemelman and CJ Buskens) of this study. The steering committee will 
comment on the reports. 
 
STATISTICAL ANALYSIS 
 

Version 4 – May 16th 2017                        The SuperSeton Pilot Study  
 
 
 
 
16 of 22 
6.9 Statistics 
All data will be collected in an electronic database by the AMC study coordinator. The outcome 
parameters will be analysed after 3 months follow up with appropriate statistical tests using the 
statistical program SPSS. A two-tailed p < 0.05 is considered statistically significant. Descriptive 
statistics will be used to describe patient characteristics and outcomes. Preoperative PDAI  scores will 
be compared to postoperative PDAI scores after 3 months follow up. Results will be analysed using 
the paired t-test. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Version 4 – May 16th 2017                        The SuperSeton Pilot Study  
 
 
 
 
17 of 22 
7. ETHICAL CONSIDERATIONS 
 
7.1 Regulation statement 
This trial will be conducted according to the principles of the declaration of Fortalezea Brazil (October 
2013) and in accordance with the Medical Research Involving Human Subjects Act (WMO) and other 
European guidelines, regulations and acts. Data management, monitoring and reporting of the study 
will be carried out in accordance with the ICH GCP guidelines. 
 
7.2 Recruitment and consent 
The information offered to the patient or representative contains: 
- A statement that the trial involves research 
- A full and fair explanation of the procedures to be followed 
- A full explanation of the nature, expected duration, and purpose of the study 
- A description of any reasonable foreseeable risks or discomfort to the patient 
- A description of any benefits which may reasonably be expected 
- A statement that patient data will be handled with care and confidentiality 
- A statement that participation is voluntary, that refusal to participate will involve no penalty or loss 
of benefits to which the patient is otherwise entitled, and that the patient may discontinue 
participation at any time without penalty or loss of benefits, in which case the patient will receive 
standard treatment with the same degree of care 
 
7.3 Objection by minors or incapacitated subjects (if applicable) 
Minors and legally incompetent adults are excluded from the trial. 
 
7.4 Compensation for injury 
The AMC Medical Research BV has insurance, which is in accordance with the legal requirements in 
The Netherlands (Article 7 WMO and the Measure regarding Compulsory Insurance for Clinical 
Research in Humans of June 23, 2003). This insurance provides cover for damage to research subjects 
through injury or death caused by the trial:  
- € 450.000,-- (i.e. four hundred and fifty thousand Euro) for death or injury for each subject who 
participates in the research;  
- € 3.500.000,-- (i.e. three million five hundred thousand Euro) for death or injury for all subjects who 
participate in the research;  
- € 5.000.000,-- (i.e. five million Euro) for the total damage incurred by the organization for all  
damage disclosed by scientific research for the AMC as ‘Sponsor (verrichter)’ in the meaning of said 
Act in each year of insurance coverage. The insurance applies to the damage that becomes apparent 
during the study or within 4 years after.  

Version 4 – May 16th 2017                        The SuperSeton Pilot Study  
 
 
 
 
18 of 22 
The insurance applies to the damage that becomes apparent during the study or within 4 years after the 
end of the study.  
 
7.5 Incentives (if applicable) 
Enrolled patients will not receive any special incentives, compensation or treatment through 
participation in this trial, except for covering of travel expenses in case of additional appointments to 
standard care. 
 
7.6 Handling and storage of data and documents 
Every randomised patient will be assigned a three-digit study number. Communication occurs only 
with this number. The full name and birth date of the patient will only be recorded on the informed 
consent form.    
A study coordinator coordinates the study, monitors patient inclusion and protocol steps, data 
collection, data entry, preparation and performs analyses and will report the data. Continuous data 
monitoring, and data collection on a CRF will guarantee complete and real-time prospective recording 
of data. All data (personal, medical and other relevant information) will be sent by the local 
investigators to the AMC. After study completion all data will be  stored (15 years) at the AMC in a 
separate, closed room. 
 
7.7 Monitoring 
The study will be monitored by the AMC study coordinator 
 
7.8 Amendments  
Amendments are changes made to the research after a favourable opinion by the accredited METC has 
been given. All amendments will be notified to the METC that gave a favourable opinion. All 
substantial amendments will be notified to the METC and to the competent authority. Non-substantial 
amendments will not be notified to the accredited METC and the competent authority, but will be 
recorded and filed by the sponsor. 
 
7.9 Annual safety report 
The study coordinator will submit a safety report after completion of the trial to the accredited METC. 
Information will be provided on the date of inclusion of the first subject, numbers of subjects included 
and numbers of subjects that have completed the study, serious adverse events/ serious adverse 
reactions, other problems, and amendments. 
 

Version 4 – May 16th 2017                        The SuperSeton Pilot Study  
 
 
 
 
19 of 22 
7.10 End of study report 
The investigator will notify the accredited METC of the end of the study within a period of 8 weeks. 
The end of the study is defined as the last patient’s last visit. In case the study is ended prematurely, 
the investigator will notify the accredited METC, including the reasons for the premature termination. 
Within one year after the end of the study, the investigator/sponsor will submit a final study report 
with the results of the study, including any publications/abstracts of the study, to the accredited 
METC.  
 
7.11 Public disclosure and publication policy 
Patients are entitled to public disclosure of the results of the trial on the basis of their participation in 
it. The results of research will be submitted for publication to peer-reviewed scientific journals.  
Agreements with respect to participation in publication will be made before the start of the trial. 
 
 

Version 4 – May 16th 2017                        The SuperSeton Pilot Study  
 
 
 
 
20 of 22 
8. TIME SCHEDULE 
 
July  2016:  
Obtaining Ethic Committee Approval AMC 
 
Second half of 2016 until June 2017: 
Start clinical study 
Inclusion of patients  
Follow up of included patients 
Data management 
Analysis of data 
Writing report 
 
 

Version 4 – May 16th 2017                        The SuperSeton Pilot Study  
 
 
 
 
21 of 22 
9. REFERENCES 
 
1. Vigano C. LA, Caprioli F. Basilisco G. Incidence and Clinical Outcomes of Intersphincteric 
Abscessed Diagnosed by Anal Ultrasonography in Patients with Crohn's Disease. Inflamm Bowel Dis 
2011;17:2102-8. 
 
2. A.G. P. Pathogenesis and treatment of fistula-in-ano. British medical journal 1961;1:463-9. 
 
3. Tanaka S, Matsuo K, Sasaki T, et al. Clinical advantages of combined seton placement and 
infliximab maintenance therapy for perianal fistulizing Crohn's disease: when and how were the seton 
drains removed? Hepatogastroenterology 2010;57:3-7. 
 
4. Subhas G, Singh Bhullar J, Al-Omari A, Unawane A, Mittal VK, Pearlman R. Setons in the 
treatment of anal fistula: review of variations in materials and techniques. Dig Surg 2012;29:292-300. 
 
5. Riss S. B-HT, Stift A. The Comfort Drain: a new device for treating complex anal fistula. Tech 
Coloproctol 2014;18:1133-5. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Version 4 – May 16th 2017                        The SuperSeton Pilot Study  
 
 
 
 
22 of 22 
10. APPENDIX 
 
 
Patients with perianal fistulas 
and a seton in situ or a 
recurrent perianal fistula for 
which a seton wil be placed
SuperSeton placement 
Follow-up 3 months
Assessment feasibility
(& secondary outcomes 
parameters)
 
Appendix. Figure 1: flow chart of trial design