The Russian Multicenter Observational Program Obtaining of Data on the Impact of Different Treatment Modalities on the Quality of Life of the Patients With Acute and Chronic Hemorrhoid Disease
Conditions: Hemorrhoids
Sponsor: Servier Russia

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The Russian Multicenter Observational Program  
 
Obtaining of data on the impact of different treatment modalities on the quality of 
life of the patients with acute and chronic hemorrhoid disease (EQUALISER) 
 
PROTOCOL 
 
NCT03743311 
 
 
Protocol № IC4 -05682-058-RUS 
 
 
 
Data of report: 1/03/2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Introduction 
Any long-term morbid condition associated severe physical discomfort, including hemorrhoids, is a powerful stress 
factor that affects psychological and physiological components of a person's health. 
 
As of today, about 10% of adults in total population suffer from hemorrhoids, and this disease accounts for more than 
40% of all cases of coloproctological diseases [1, 2, 3]. The prevalence of hemorrhoids is about 130-145 cases per 
1,000 adult population, and in the group of middle-aged and elderly adults it reaches 210-240 cases per 1,000 
population [2, 4]. 
 
The main method of treating chronic hemorrhoids of grade III-IV is surgical one [2, 3]. At the same time, the symptoms 
of hemorrhoids in grade 1-2 are successfully relieved with conservative treatment. 
 
Criteria for assessing the treatment efficacy in acute and chronic hemorrhoids are the rates of complications and relapse 
of the major clinical manifestations of the disease. In addition to quantitative indicators of treatment efficacy, qualitative 
methods are becoming increasingly important, and one of them is an assessment of the quality of life (QoL) of patients 
[5, 7,6]. The purpose of this program is to obtain data on the effect of different treatment approaches in acute and 
chronic hemorrhoids in a broad cohort of patients in routine clinical practice. 
 
References:  
1. Благодарный Л.А. Как улучшить результаты хирургического лечения геморроя / Л.А. Благодарный, Ю.А. 
Шелыгин. // Consilium Medicum. Хирургия. – 2006. – № 1.– С. 49–52.  
[Blagoradny L.A. How to improve the results of surgical treatment of hemorrhoids / Blagoradny L.A., Shelygin Yu.A. // 
Consilium Medicum. Surgery.(Supplement). - 2006. - No. 1. - P. 49-52. (in Russ.)] 
2. Воробьев Г.И. Геморрой / Г.И. Воробьев, Ю.А. Шелыгин, Л.А. Благодарный. – М.: Литтерра, 2010. – 200 с. 
[Vorobyev G.I. Hemorrhoids / Vorobiev G.I., Shelygin Yu.A., Blagoradny L.A.. - Moscow: Litterra, 2010. - 200 p. (in 
Russ.)] 
3. Ривкин В.Л. Геморрой и другие заболевания заднепроходного канала / В.Л. Ривкин, Ю.В. Дульцев, Л.Л. 
Капуллер. – М.: Медицина, 1994. – 239 с. 
[Rivkin V.L. Hemorrhoids and other diseases of anal canal / Rivkin V.L., Dultsev Yu.V., Cappuiller L.L. - Moscow: 
Medicine, 1994. - 239 p. (in Russ.)] 
4. Шелыгин Ю.А. Выбор способа геморроидэктомии при хроническом геморрое / Ю.А. Шелыгин, Л.А. 
Благодарный, Л.М. Хмылов. // Хирургия. – 2003. – № 3. – С. 39–45. 
[Shelygin Yu.A. Choice of hemorrhoidectomy in chronic hemorrhoids / Shelygin Yu.A., Blagoradny L.A., Khmylov L.M. // 
Surgery. - 2003. - No. 3. - P. 39-45.] 
5. Добровольский С.Р. Исследование качества жизни больных в хирургии / С.Р. Добровольский, Ю.Х. 
Абдурахманов, Э.К. Джамынчиев [и др.]. // Хирургия. Журнал им. Н.И. Пирогова. – 2008. – № 12. – С. 73–76. 
[Dobrovolsky S.R. A study of the quality of life of patients in surgery / Dobrovolsky S.R., Abdurakhmanov Yu.Kh., 
Dzhamynchiev E.K. et al. // Surgery. Journal named after N.I. Pirogov. - 2008. - No. 12. - P. 73-76] 
6. Дмитриева Л.В. Изучение качества жизни у больных, страдающих геморроем / Л.В. Дмитриева, Р.Ю. 
Муртазина. // Успехи современного естествознания. – 2013. – № 9. – С. 77–78. 
[Dmitrieva L.V. A study of the quality of life in patients with hemorrhoids / Dmitrieva L.V., Murtazin R.Yu. // The 
successes of modern natural science. - 2013. - No. 9. - P. 77-78]. 
7. Новик А.А. Руководство по исследованию качества жизни в медицине / А.А. Новик, Т.И. Ионова. – М.: РАЕН, 
2012. – 528 с. 
[Novik A.A. Guide to the study of the quality of life in medicine / Novik A.A., Ionov T.I. - Moscow: RANS, 2012. - 528 p.]  
 
Aims and goals of the program: 
The program is aimed at obtaining data on the impact of the method and type of treatment on the quality of life of 
patients with acute or chronic hemorrhoids.  
 
Primary endpoints: 

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• 
Changes in the quality of life of patients suffering from acute or chronic hemorrhoids within 1 month after 
presenting to a doctor, in general population and in specific demographic and clinical groups. 
 
Secondary endpoints: 
• 
Scores for different health status dimensions of the SF36 questionnaire in patients suffering from acute or 
chronic hemorrhoids, and their association with demographic and clinical parameters, as well as the chosen 
treatment strategies (surgical, minimally invasive, or conservative). 
• 
Changes in the QoL of patients suffering from acute or chronic hemorrhoids, who underwent surgical 
intervention, within 1 month after presenting to a doctor.  
• 
Changes in the QoL of patients suffering from acute or chronic hemorrhoids, who received conserative 
treatment, within 1 month after presenting to a doctor. 
• 
Changes in the QoL of patients suffering from acute or chronic hemorrhoids, who received combination 
treatment, within 1 month after presenting to a doctor. 
• 
Changes in the QoL of patients suffering from acute or chronic hemorrhoids, who underwent minimally invasive 
interventions, within 1 month after presenting to a doctor.  
• 
Changes in clinical manifestations in patients suffering from acute or chronic hemorrhoids, and their association 
with demographic and clinical parameters, as well as the chosen treatment strategies (surgical, minimally 
invasive, or conservative). 
• 
Patient’s compliance with recommendations of a doctor. 
 
Design:  
 
The EQUALISER program is a Russian, multicenter, observational program. 
In Russia, the program is scheduled for 2018-2019. It is expected that 90 doctors will take part in the program in 60 
cities of the Russian Federation. The planned number of patients is 900. Each participating doctor includes at least 10 
patients and fills out an electronic case report form (CRF). All treatment is carried out in accordance with the instructions 
for medical use and routine clinical practice.  
 
First visit of the first patient 
 
  
02\2019 
Last visit of the last patient             
 
05\2019 
Completion of statistical analysis 
 
08\2019 
Preliminary report 
 
 
 
12\2019 
 
Final report 
 
 
 
             03\2020 
 
Methods: 
During the program, at each visit the leading clinical symptoms of hemorrhoids will be assessed. 
The quality of life assessment will be carried out using the validated questionnaire SF36  (in Russian) (Appendix 2) 
Inclusion visit (V0) 
Patients who meet the inclusion criteria will be included in the program, and for them the CRF will be completed. 
Visit 1 (V1) Surgical intervention (if applicable).  
Visit 2 (V2) in 5-7 days after surgical intervention or 5-7 days after the Inclusion Visit (V0), if intervention was not 
performed. 
Visit 3 (V3) in 25-30 days after surgical intervention or 25-30 days after Inclusion Visit (V0), if intervention was not 
performed. 
 
Visit 
Actions 
V0 
• Signing the Informed Consent Form 

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• Checking of fulfilment of inclusion/non-inclusion criteria. 
• Obtaining the data: 
- Disease duration  
- Clinical manifestations of haemorrhoids 
- клинические проявления геморроя:   
• 
prolapse of hemorrhoids (Appendix 4) 
• 
pain, itching, dyscomfort (Appendix 6) 
• 
bleeding 
- The Rome III criteria for constipation (Appendix 3) 
- Conservative treatment (systemic venotonic drug, topical agents, analgetics) 
- Diagnosis according to the National guidelines on coloproctology, 2015 (Appendix 5) 
 
- The surgical treatment scheduled  
- QoL assessment using the SF36  scale (Appendix 2) 
 
V1 
• Surgical treatment (if performed) 
 
V2 
• 5-7 days after intervention or after V0, if intervention was not performed 
• Clinical manifestations of haemorrhoids at the day of visit 
• Patient’s compliance with doctor recommendations 
• Recording the adverse events (Appendix 1). 
• Assessment of pain, itching, and discomfort using VAS (Appendix 5) 
 
V3 
• 25-30 days after intervention or after V0, if intervention was not performed 
• Clinical manifestations of haemorrhoids at the day of visit 
• Patient’s compliance with doctor recommendations 
• Patient’s satisfaction with the treatment 
• Recording the adverse events  
• Clinical manifestations of haemorrhoids at the day of visit 
• QoL assessment using the SF36 scale 
 
 
Inclusion criteria  
Patients fulfilment of the criteria of the inclusion in the program will be determined by the following parameters: 
1) Age over 18 years;  
2) Providing written information to a patient about inclusion in the program, and his/her consent to participate in it,  
3) Absence of conditions requiring urgent medical care and not related to hemorrhoids;  
4) The patient was diagnosed with:   
▪ Acute hemorrhoids (with thrombosis of hemorrhoids); 
▪ Exacerbation of chronic hemorrhoids (pain, bleeding, oedema (swelling) of hemorrhoids); 
▪ Chronic hemorrhoids (prolapsed hemorrhoids, bleeding events, anal discomfort). 
 
Exclusion criteria  
1) The patient is consulting for an urgent issue not related to hemorrhoids; 
2) The presence of severe systemic diseases; 
3) Pregnancy; 

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4) Inability to understand the meaning of the Program and follow the doctor's recommendations 
5) Patients with inflammatory bowel diseases (Crohn's disease, non-specific ulcerative colitis); 
6) Patients with concomitant diseases of the anal canal (fissure, fistulas, paraproctitis, etc.); 
7) Patients taking anticoagulants; 
8) Patients with previous anorectal surgeries, including hemorrhoidectomy or excision of anal fistula. 
 
Treatment 
 
The observational nature of program presumes that all examinations, procedures and changes in the treatment of 
patients, including changes in the dosing regimen, should be carried out only on the basis of judgment of the treating 
physician and in full compliance with the guidelines on the treatment of patients of the analysed population, instructions 
for medical use of drugs, and in the settings of daily routine practice. 
Therapy is conducted in full accordance with existing guidelines. The patient’s participation in the program, as well as 
his/her refusal to continue such participation, should not affect the current treatment, the availability of diagnostic 
procedures or the volume and quality of other necessary medical care. 
 

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Safety considerations 
1. 
Definitions 
1.1 Pharmacovigilance information  
Pharmacovigilance data include any unintended or adverse event associated with the use of a medicinal product in 
humans, whether or not considered drug related, including the following special situations (situations where no adverse 
event occurred but information needs to be collected): 
- exposure during pregnancy or breastfeeding;  
- overdose, abuse, misuse, off-label uses, medication error, occupational exposure (including professional one); 
- lack of the treatment efficacy of drug. 
 
1.2. Adverse Event (AE) 
Adverse event is any untoward medical occurrence in a patient or a clinical-trial subject who received the medicinal 
product, which does not necessarily have a causal relationship with the use of this medicinal product. 
An adverse event can therefore be any unfavourable and unintended sign (e.g. an abnormal laboratory finding), 
symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the 
medicinal product. 
 
1.3. Adverse (drug) reaction (ADR)  
Adverse reaction (synonyms: Adverse drug reaction, Suspected adverse (drug) reaction, Adverse effect, Undesirable 
effect) is a response to a medicinal product which is noxious and unintended.  
“Response” in this context means that a causal relationship between a medicinal product and an adverse event is at 
least a reasonable possibility.  
Adverse reactions may arise from use of the product within or outside the terms of the marketing authorization or from 
occupational exposure. Conditions of use outside the marketing authorization include off-label use, overdose, misuse, 
abuse and medication errors. 
 
1.4. Serious adverse (drug) reaction (SADR)     
Serious adverse reaction is an adverse reaction, which results in death, is life-threatening, requires in-patient 
hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a 
congenital anomaly/birth defect. 
“Life threatening” in this context refers to a reaction in which the patient was at risk of death at the time of the reaction; it 
does not refer to a reaction that hypothetically might have caused death if more severe. 
Medical and scientific judgement should be exercised in deciding whether other situations should be considered serious 
reactions, such as important medical events that might not be immediately life threatening or result in death or 
hospitalisation but might jeopardise the patient or might require intervention to prevent one of the other outcomes listed 
above. 

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Examples of such events are intensive treatment in an emergency room or at home for allergic bronchospasm, blood 
dyscrasias or convulsions that do not result in hospitalisation or development of dependency or abuse. 
Any suspected transmission via a medicinal product of an infectious agent is also considered a serious adverse 
reaction. 
 
2. Responsibilities  
2.1. Events to be reported  
All available information about the following reported events occurring during the study will be recorded:   
- 
All serious adverse drug reactions related to the use to Detralex 
- 
All non-serious adverse drug reactions related to the use to Detralex 
- 
All reports about special situations (see 1.1) 
- 
All adverse events 
 
2.2. Responsibilities of the investigator 
In prospective studies, at medical visits, the investigator will ask the participating patient to indicate whether or not an 
adverse event (serious or not) has occurred. 
The investigator has to assess the causal relationship between an adverse event and the investigated drug intake, as 
well as the seriousness criteria and later on the outcome of the event.  
In case of Adverse Events, Adverse Drug Reactions or special situations that occurs during the study (both serious and 
non-serious), the investigator must complete the “Adverse event / Adverse drug reaction / Special Situation Reporting 
Form” (Appendix 1) without waiting for the clinical outcome or the results of additional investigations.  
When assessing the quality of life using the EQ-5D, the investigator should evaluate data (patient's answers), their 
clinical relevance, and fill out the " Adverse event / Adverse drug reaction / Special Situation Reporting Form” if he/she 
considers these data as AE, ADR or a special situation. 
If the event is serious, it will be notified immediately (same or next working day at the latest) to Servier company in 
Russia via e-mail to address pvmail.rus@servier.com or by fax to number (495) 937-47-66. The anonymized copies of 
all the available and relevant laboratory findings, hospitalisation reports or other investigation results performed in 
connection with the adverse event should be attached to the form. 
All other events should be reported by investigator within 2 working days. 
The same rules apply for the transferring of additional information about the event.  
The investigator must ensure the appropriate follow-up of the patient depending on the nature of event, until it resolves. 
The investigator will continue to notify follow up data according to timeframes defined above. 
If investigator does not follow-up a patients anymore (i.e. in case of hospitalisation followed by the treatment by 
specialist or the participant's general practitioner,…), he/she will do every effort to contact the specialist or department in 
charge of follow-up of the patient, so as to have additional information and report it to Servier company in Russia. 
 

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2.3. Responsibilities of the Sponsor/Marketing Authorisation Holder  
Independently of the regulatory obligations of investigator, the sponsor/MAH must report the pharmacovigilance data to 
the appropriate authorities in accordance with the Good Vigilance Practice and local regulations. 
Cases are closed when an adverse event has recovered or patient’s condition was stabilised and the report is deemed 
sufficiently detailed for adequate medical analysis of the case. 
 
Ethical considerations 
 
The study will be conducted in accordance with the principles set out in the Declaration of Helsinki (version adopted 
in Fortaleza, Brazil, in 2013). 
The protocol of the program was reviewed and approved in accordance with the legislation of the Russian 
Federation and will be followed by the sponsor, in particular, with regard to data collection. Participants will be fully 
informed and provide their written consent to participate in the program. Investigator is obliged to indicate in the CRF 
that the informed consent was obtained from the patient, as well as to keep the signed Form in the clinical file for the 
participant. The “informed consent” also means that individual discussion with participant concerning the nature of 
the program and the necessary investigations. Sponsor will not have access to the data allowing identification of 
participants. Documents relating to the study will be reviewed by Ethical committee. 
 
Organizational structure and responsibilities 
 
Investigators 
Investigators will receive informed consent forms and enroll participants, ensure data collection in accordance with 
the protocol, fill in case report forms and verify the accuracy of information in these case report forms, as much as 
possible. The patient will be provided with all information to obtain informed consent. At the same time, participants 
will be asked to consent to the use of their personal data. The data of the participants will remain completely 
confidential. 
 
Sponsor  
The sponsor will be responsible for all stages of the program, for providing the resources necessary to initiate and 
run the program in accordance with local regulations, as well as for the validity of the recorded data. 
 
 
Statistical parameters 
 
Variables: 
 
• 
Change in the mean score of the EQ-5D index in patients suffering from acute or chronic hemorrhoids within 1 
month after presenting a doctor, in general population and in specific demographic and clinical groups. 
• 
Rates (in %) of different variables of health profile according to the EQ-5D in patients suffering from acute or 
chronic hemorrhoids, and their relationship to demographic, clinical parameters and the chosen treatment 
strategies (surgical, minimally invasive, and conservative). 
• 
Change in the mean score of the EQ-5D index in patients suffering from acute or chronic hemorrhoids, who 
underwent surgical intervention, within 1 month after presenting to a doctor 
• 
Change in the mean score of the EQ-5D index in patients suffering from acute or chronic hemorrhoids, who 
received conservative treatment, within 1 month after presenting to a doctor 
• 
Change in the mean score of the EQ-5D index in patients suffering from acute or chronic hemorrhoids, who 
received combination treatment, within 1 month after presenting to a doctor 
• 
Change in the mean score of the EQ-5D index in patients suffering from acute or chronic hemorrhoids, who 
underwent minimally invasive intervention, within 1 month after presenting to a doctor 

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• 
Change in the mean score by VAS (in mm) scale from SF36 questionnaire in patients suffering from acute or 
chronic hemorrhoids, who underwent surgical intervention, within 1 month after presenting a doctor, in general 
population and in specific demographic groups 
• 
Change in the mean score by VAS (in mm) scale from SF36 questionnaire in patients suffering from acute or 
chronic hemorrhoids, who received conservative treatment, within 1 month after presenting to a doctor 
• 
Change in the mean score by VAS (in mm) scale from SF36 questionnaire in patients suffering from acute or 
chronic hemorrhoids, who received combination treatment, within 1 month after presenting to a doctor 
• 
Change in the mean score by VAS (in mm) scale from SF36 questionnaire in patients suffering from acute or 
chronic hemorrhoids, who underwent minimally invasive intervention, within 1 month after presenting to a doctor 
• 
Change in the mean score by VAS (in mm) scale from CRF for pain, itching, and discomfort in patients suffering 
from acute or chronic hemorrhoids, within 1 month after presenting to a doctor, and their relationship to 
demographic, clinical parameters and the chosen treatment strategies (surgical, minimally invasive, and 
conservative). 
• 
Change in the proportion (in %) of patients with bleeding events or prolapse of hemorrhoids among patients 
suffering from acute or chronic hemorrhoids, within 1 month after presenting a doctor, and its relationship to 
demographic, clinical parameters and the chosen treatment strategies (surgical, minimally invasive, and 
conservative). 
• 
Proportion (%) of patients compliant with recommendations on lifestyle changes 
• 
Proportion (%) of patients compliant with recommendations on medical therapy. 
 
Statistical analysis: 
Baseline characteristics will be analyzed in all included patients despite adherence to the protocol. Analysis of the 
results of program will be performed using the SPSS 12.0 software package (SPSS Inc., USA). The data entry errors 
will be corrected before the statistical processing. Quantitative parameters will be presented depending on the 
distribution of primary data as arithmetic mean ± standard deviation for parametric variables, or as median (25; 75 
percentiles) for nonparametric variables. Multiple comparisons will include adjustments for continuity.  
Changes in the quantitative parameters during the follow-up period will be evaluated using the Student's t-test for paired 
samples or its nonparametric analogue, Wilcoxon test. Differences on the quantitative parameters, both between the 
independent groups and during the follow-up, will be evaluated as the mean difference with the corresponding 95% 
confidence interval. 
Comparisons of changes on the VAS scales and the Rome III constipation scale will be carried out using two-factor 
analysis of variance (ANOVA) with repeated measures to compare the scores before and after the treatment. 
Adverse events will be recorded and analyzed in patients with the reporting of all the AEs, SAEs, ADRs, SADRs and 
special situations. 
 
Administrative considerations 
The right to own the documentation, data and results of the program. 
The sponsor reserves the exclusive rights for all materials, information, unpublished documentation, results and 
information received during the program. The sponsor reserves the right to send data on the program (case report 
forms, results of analyses, and reports) to health authorities. 
No unpublished documentation or information transmitted to investigators can be transferred to unauthorized 
persons without the prior written consent of the Sponsor. 
 
Publication and communication 
Sponsor is responsible for communication and publication of data on the program. No aspect of the results of this 
program or other data may be published, presented, or distributed without the explicit written permission of Sponsor. 
Participants of the program fully transfer to the Sponsor the authority for the first presentation, communication and 
publication of the results on behalf of all employees. No other communication or publication is permitted before this 
first publication. Any subsequent communication or publication must first be considered and approved by the 
Sponsor and must refer to the program and the first publication. 

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APPENDIX 1 
Adverse event / Adverse drug reaction / Special Situation Reporting Form*  
 
IC4-05682-058-RUS Please send this form immediately by fax (495) 937-47-66 or by email to 
pvmail.rus@servier.com, or pass to the associate of the company. 
Year of birth   or      Age              Gender 
  Height 
 Weight                       Patient’s ID: 
 
|__|__|__|__|       or   |__|__|__|             M / F 
  |__|__|__| 
  |__|__|__| 
        |_|_|_|_|_|_|_|_|_|_| 
     
Description of adverse event/reaction/special situation: 
Date of event onset 
 
|_|_|  |_|_|  |_|_|_|_| 
Date of event  
termination (in case 
of recovery) 
 
|_|_|  |_|_|  |_|_|_|_| 
 
 
 
Criteria of seriousness:  NO 
 
                        YES (please, specify from stated below)  
 
 Death   
 
 Life threatening 
 
 Hospitalization or prolongation of existing hospitalisation 
 
 Persistent or significant disability or incapacity 
 
 Congenital anomaly/birth defect 
 
    Medically important event 
Outcome: 
 
 Recovered    
 
 Recovered with consequences (persistent  
      structural or functional impairment) 
 
 Not yet recovered   
 
 No recovery 
 
 Death  
 
 Unknown 
General disease(s) / Concomitant disease(s) (please indicate year when first diagnosed). 
Course adverse event/reaction/special situation (please enclose relevant findings, e.g. laboratory, hospital reports, 
histology, etc.): 
 
Causal relationship with intake of investigational drug:⁬ 
 
 NO 
          
 YES  
 NOT APPLICABLE 
 
If  «Yes», please indicate dates of the use of investigational drug in the first line of the table below:  
 
If «No» or «Not applicable», please specify whether the adverse event/special situation is related to the medication 
of Servier company (which is specified in the table below): 
  NO         YES 
Please indicate the name of the medication of Servier company: ………………………… 
List of current 
medications  
Daily dose / 
route of 
administration
Dates of intake: 
from 
to 
Indication 
 
 
- 
 
 
 
 
 
 
 
- 
 
 
 
- 
 
 
 
 
 
Name (last, first, patronymic) of doctor:  
Speciality:  
Work address: 
Phone number: ________________________________________ 
                                 (city code) 
Date:                                                         
 
 
Signature: 
*Special situations are cases when adverse event was not observed, but the information should be collected: the impact of the drug during 
pregnancy/breastfeeding, abuse, misuse, medication error, overdose, off-label use, occupational exposure, or treatment failure…  
Stamp 
(whenever 
possible) 

11 
 
APPENDIX 2 SF36 Questionnaire 
 
 
 
 
 
 
 
 

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13 
 

14 
 
 
 
 
 
 

15 
 
 
 
APPENDIX 3. The Rome III diagnostic criteria for the constipation 
 
Symptoms 
 
Characteristics of the symptoms 
1. Straining during at least 25% of defecations 
 
 
Symptoms should be observed within 12 weeks (not 
necessarily consecutive) during the previous year. 
 
Syndrome must include two or more of the symptoms 
listed in this table. 
 
2. Lumpy or hard stools in at least 25% of 
defecations 
 
3. Sensation of incomplete evacuation for at 
least 25% of defecations  
 

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4. Sensation of anorectal obstruction/blockage 
for at least 25% of defecations  
 
5. Manual maneuvers to facilitate at least 25% 
of defecations (e.g., digital evacuation, 
support of the pelvic floor) 
 
6. Fewer than three defecations per week 
 
 
 
APPENDIX 4 
 
Classification of internal hemorrhoids (Goligher’s classification) 
 
*Assessment criteria: 
Grade I 
Hemorrhoids are prolapsed only into the anal canal. 
Grade II 
Bleeding and prolapse of hemorrhoids. Hemorrhoids spontaneously reduce after defecation. 
Grade III 
Prolapse of hemorrhoids after defecation requires their manual reduction. 
Grade IV 
Prolapse of hemorrhoids that cannot be reduced into the anal canal. 
 
APPENDIX 5. 
Example of wording of the diagnosis statement (National guidelines on coloproctology, 2015) 
 
 
Internal hemorrhoids (II- 3, III- 7, II-11) 
 
External (3А, 7В) and internal hemorrhoids (II- 3, III- 7, II-11) 
 
External hemorrhoids, complicated by an acute thrombosis of grade 2 (7 o`clock). 
 
 
APPENDIX 6. 
Visual analogue scale (VAS) 
 
«Not at all»                                                     «Most severe … ever experienced» 
 
 
 
|__|__| , |__| cm *