Haemorrhoidal Disease
Conditions
Keywords
haemorroidal disease, haemorroidal crisis, internal haemorroids, external haemorroids, anal irritation
Brief summary
This trial aims to evaluate the overall performance and safety of the MD PROCTOeze® PLUS in relieving symptomatology of haemorrhoidal disease and anal irritation in adult patients affected by Grade I-II (Goligher classification) haemorrhoids as assessed by the patient and the Investigator at the end of the treatment period.
Detailed description
The protocol is based on what is already known on both the topic object of the study, i.e., the symptomatic treatment of haemorrhoids, and the investigational medical device - PROCTOeze® PLUS - which is a specific adjuvant for the symptomatic relief of internal and external haemorrhoids and anal irritation. Due to its formulation, it contributes to the physiological restoration of the anal and perianal tissues. The tool used in this research is a PMCF, a procedure which, through a scientific method of detection (one or more questionnaires to be submitted to a representative sample of patients related to the issue of the research), allows to collect, and subsequently analyse, the data needed to study the relationships between different variables.
Interventions
DEVICEHydrophilic emulsion for the relief of haemorroidal symptoms
Administration for 2 weeks of PROCTOeze® PLUS - a soft and light hydrophilic emulsion able to provide symptomatic relief of haemorrhoids and anal irritation.
Sponsors
Biokosmes Srl
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women ≥ 18 years old. * Patients diagnosed with Grade I - II symptomatic haemorrhoids (according to Goligher classification) confirmed by clinical and anoscopic or proctoscopic examination performed within 3 months before baseline. * Patients able to do self-administration at home of the MD, for 14 days, to treat symptoms of haemorrhoids and anal irritation. * Patient free from the following treatments for haemorrhoids for at least 4 weeks: laser treatments for haemorrhoids, steroidal or non-steroidal anti-inflammatory drugs, analgesics, any anti-haemorrhoidal treatment, anticoagulants, and antiplatelet agents. * Patients able to communicate adequately with the Investigator and understand the tral questionnaire. * Patients able to understand and who can provide valid informed consent to the trial.
Exclusion criteria
* Inflammatory and infectious disease of the digestive tract (e.g., IBD - Inflammatory Bowel Disease). * Frequent hemorraidal bleeding * Severe, uncontrolled hypertension, renal failure, cirrhosis, colorectal cancer, anal fissure or fistula. * Patients with known sensitivity to the tested medical device or its components. * Patients with any other medical condition that, in the opinion of the Investigator, would compromise participation or be likely to lead to hospitalisation during the study. * Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Performance by the Improvement in the Quality of Life Measured Through the Score on The Short Health Scale for Haemorrhoidal Disease (SHSHD) | From enrollment to the end of treatment on day 14. | The Short Health Scale for Haemorrhoidal Disease (SHSHD) will be used to evaluate the Quality of Life. The questionnaire will be completed by the patient at baseline and day 14, at the end of the treatment with the MD. Grades on a scale from 1 to 7, where lower grades are better, with a total of 4 items on the scale (minimum score 4, maximum score 28). Is an instrument with just 1 question in each of its 4 dimensions, including symptom burden, functional status, disease-specific worries, and general well-being measured according to A 7-point Likert scale to be summed giving a total score ranging from 4 to 28. The total of the four dimensions has been analyzed. The unit of measure is "score". SHS was adapted for HD (Short Health Scale for Haemorrhoidal Disease - SHSHD) in accordance with the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) guidelines; SHSHD has shown to be a reliable and responsive measure for HRQoL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Performance Through the Score on Haemorrhoid Severity Score (HSS) Reported by Physician | From enrollment to the end of treatment on day 14. | HSS is a physician-reported measurement instrument based on PNR-Bleed classification. All four components in this classification system are graded into five grades ranging from 1 to 5. Grade 1 is the normal anal cushions and Grade 5 is the worst grade in a specific characteristic. HSS is the total score obtained by the sum of the numerical grades of all four characteristics of haemorrhoids in the PNR-Bleed classification. The minimum HSS score is 4 and the maximum score can be 20. The HSS score of a normal person without any signs and symptoms of haemorrhoids is 4. Calculation of the HSS helps in the quantification of the haemorrhoidal disease for further reference and is helpful in post-treatment patient follow-up to grade the response to treatment and to assess the effectiveness or failure of any particular treatment regimen for haemorrhoids. The total of the four dimensions has been analyzed. The unit of measure is "score". |
| Assessment of Performance Through the Score Haemorrhoidal Disease Symptom Score (HDSS) Reported by Patient | From enrollment to the end of treatment on day 14. | The Haemorrhoidal Disease Symptom Score (HDSS), a patient-reported outcome questionnaire, will be administered by Investigator to each patient at baseline and at day 14, at the end of the treatment with the MD. Grades on a scale from 1 to 5, where lower grades are better, with a total of 5 items on the questionnaire. The HDSS is a patient-reported measurement instrument. It comprises five items. Symptoms are assessed using the patient-reported frequency of the 5 symptoms, including pain, itching, bleeding, soiling, and prolapse. Patients are instructed to answer based on their experience during the previous period. Each symptom is graded on a 5-point scale (0 = never, 1 = less than once a month, 2 = less than once a week, 3 = 1-6 days per week, 4 = every day or always), giving a total score ranging from 0 to 20. The total of the four dimensions has been analyzed. The unit of measure is "score". |
| Number of Treatment-emergent Adverse Events | From enrollment to the end of study on day 30. | Safety and tolerability will be evaluated through the incidence of Adverse Event, Serious Adverse Event, Adverse Device Effect, Serious Adverse Device Effect, Anticipated Serious Adverse Device Effect, and Unanticipated Serious Adverse Device Effect assessed by Investigator and reported according to the current legislation for the whole study period. Device Deficiency will be also evaluated. The number of adverse events recorded will be evaluated to measure the safety of the MD. |
Countries
Romania
Contacts
PRINCIPAL_INVESTIGATORLucia Cristina Sisu, Dr.
CMI Dr Sisu Lucia Cristina
Participant flow
Recruitment details
Start of enrolment (FPI) 5th November 2024; End of enrolment (LPI) 17th December 2024; End of treatment (LPO) 17th January 2025. Recruitment in the ambulatory of a General Physician office.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 43 Participants |
| Age, Continuous | 49.9 Years STANDARD_DEVIATION 13.9 |
| Patients diagnosed with Grade I - II symptomatic haemorrhoids (Goligher classification) | 8.50 Score STANDARD_DEVIATION 2.11 |
| Quality of Life measured by The Haemorrhoidal Disease Symptom Score (HDSS) | 10.12 Score STANDARD_DEVIATION 3.6 |
| Quality of Life measured by The Short Health Scale for Haemorrhoidal Disease (SHSHD) | 14.04 Score STANDARD_DEVIATION 7.79 |
| Region of Enrollment Romania | 50 participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
None listed