HemorrhoidsNCT05772351
Preoperative Micronized Flavonoid Fraction (MFF) Use in Multimodal Anesthesia in Anorectal Surgery
A study testing micronized flavonoid fraction in people with Hemorrhoids and Hemorrhoid Pain, run by Center of Endourology "Endocenter" at 1 site in Russia.
Trial summary
Aim: To assess the efficiency of the micro-flavonoid fraction (MMF) administration prior to anorectal surgery with spinal anesthesia on postoperative pain severity reduction. Methods: Patients who meet the following criteria are included: participants must be diagnosed with surgical treatment of anorectal diseases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemorrhoids, Hemorrhoid Pain, Hemorrhoidal Bleeding
- What is being tested?
- micronized flavonoid fraction
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteRussia
- Study dates
- 25 Nov 2021to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage 2-4 hemorrhoidal disease;
- Presence of indications for elective surgery (open hemorrhoidectomy) using mono or bipolar coagulation possibly combined with other minimally invasive methods: hemorrhoidopexy and mucopexy, Ligasure hemorrhoidectomy;
- Absence of other diseases that cause pain;
- Class I, II ASA anesthesia risk;
Who cannot join
- The presence of the following diseases: paraproctitis, inflammatory bowel disease, metabolic or endocrine disorders, alcoholism, drug use, blood clotting disorders, and history of diseases in the anorectal region;
- Contraindicated or technically impossible subarachnoid anesthesia;
- Patients who refused to participate;
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Lomonosov Moscow State University, Fundamental Medicine Faculty
Moscow, 119991
About this study
Official title: Preoperative Micronized Flavonoid Fraction (MFF) Use in Multimodal Anesthesia in Anorectal Surgery: Study Protocol for Prospective, Randomized, Placebo-controlled, Double-blind Study
Aim: To assess the efficiency of the micro-flavonoid fraction (MMF) administration prior to anorectal surgery with spinal anesthesia on postoperative pain severity reduction.
Methods: Patients who meet the following criteria are included: participants must be diagnosed with surgical treatment of anorectal diseases. All participants are randomly divided into 2 groups: the first one gets a tablet with 1000 mg MFF (Detralex®), the second one gets a tablet containing starch per os 14 days before surgery (72 participants per arm). Then patients of each group will continue MFF administration for 30 days after surgery. Patients of both arms receive spinal anesthesia and undergo surgery. Following the procedure the primary and secondary outcomes are evaluated: frequency of the opioid drugs intake, the severity of the postoperative pain syndrome, duration and frequency of other drugs intake, readmission rate, overall quality of life, time from the procedure to returning to work and the complications rate, C-reactive protein level.
Discussion: the MFF intake allows reducing the severity of the hemorrhoidal disease symptoms during conservative treatment. In addition, the Detralex® efficacy has been proven in postoperative pain reduction for patients diagnosed with varicose veins of the lower extremities. The investigators intend to evaluate the feasibility of the preoperative MFF administration for the postoperative pain reduction and the decrease of the postoperative complications in patients with hemorrhoidal disease.
- Conditions
- Hemorrhoids, Hemorrhoid Pain, Hemorrhoidal Bleeding
- Being tested
- micronized flavonoid fraction
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micronized flavonoid fractionDrug
Patients of the experimental group received Detralex® 1000 mg QD for 15 days before the operation, 3000 mg starting from day 1 after the surgery for 4 days, then 2000 mg for the next 3 days and 1000 mg till day 30 after surgery.
Under spinal anesthesia appropriate surgical intervention was performed. After the surgery, the patient was given a questionnaire and a scale for assessing pain at rest and during defecation within the first 2 weeks after surgery. During the hospital stay, the nurse filled out a section on the drugs used; after discharge, the patient filled out this section for 7 days after the surgery. After 30 days, the side effects section was filled out, and the quality of life was assessed on days 7 and 30. Also, the patients indicated in a separate column on which day after the surgery they were able to return to normal living or go to work.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients of the experimental group received Detralex® 1000 mg QD for 15 days before the operation, 3000 mg starting from day 1 after the surgery for 4 days, then 2000 mg for the next 3 days and 1000 mg till day 30 after surgery Receives: Drug: micronized flavonoid fraction |
| Control group | No intervention | Patients of the control group received a tablet containing starch. |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of prescribing opioid analgesics
the rate of prescribing opioid analgesics to prevent the pain from rising above VAS 5 after surgery
Measured: 7 days after surgery
Secondary outcomes (6)
pain at rest and during defecation
The pain was assessed using a visual analogue scale (VAS, 0 to 10 points, where 10 is the maximum score).
Measured: 15 days after surgery
other medications use
the need for other medications after surgery
Measured: 7 days after surgery
readmission rate
Measured: 30 days after surgery
The life quality rate
The overall quality of life was assessed using the EQ-5D patient questionnaire.
Measured: 7 and 30 days
time from surgery to return to work
Measured: during 30 days after surgery
complication rates
bleeding, urinary retention, infectious complications
Measured: within 30 days after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start25 Nov 2021
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center of Endourology "Endocenter"
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772351
- Sponsor's protocol ID
- 5995465475
- Status last verified
- Aug 2023
- First submitted
- 6 Mar 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Micronized Flavonoid Fraction (MFF) Use in Multimodal Anesthesia in Anorectal Surgery: Study Protocol for Prospective, Randomized, Placebo-controlled, Double-blind Study
- ClinicalTrials.gov ID
- NCT05772351
- Acronym / sponsor ID
- 5995465475
- Conditions
- Hemorrhoids, Hemorrhoid Pain, Hemorrhoidal Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Center of Endourology "Endocenter"University, hospital or other
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim: To assess the efficiency of the micro-flavonoid fraction (MMF) administration prior to anorectal surgery with spinal anesthesia on postoperative pain severity reduction.
Methods: Patients who meet the following criteria are included: participants must be diagnosed with surgical treatment of anorectal diseases. All participants are randomly divided into 2 groups: the first one gets a tablet with 1000 mg MFF (Detralex®), the second one gets a tablet containing starch per os 14 days before surgery (72 participants per arm). Then patients of each group will continue MFF administration for 30 days after surgery. Patients of both arms receive spinal anesthesia and undergo surgery. Following the procedure the primary and secondary outcomes are evaluated: frequency of the opioid drugs intake, the severity of the postoperative pain syndrome, duration and frequency of other drugs intake, readmission rate, overall quality of life, time from the procedure to returning to work and the complications rate, C-reactive protein level.
Discussion: the MFF intake allows reducing the severity of the hemorrhoidal disease symptoms during conservative treatment. In addition, the Detralex® efficacy has been proven in postoperative pain reduction for patients diagnosed with varicose veins of the lower extremities. The investigators intend to evaluate the feasibility of the preoperative MFF administration for the postoperative pain reduction and the decrease of the postoperative complications in patients with hemorrhoidal disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: micronized flavonoid fractionPatients of the experimental group received Detralex® 1000 mg QD for 15 days before the operation, 3000 mg starting from day 1 after the surgery for 4 days, then 2000 mg for the next 3 days and 1000 mg till day 30 after surgery |
| Control group | No intervention | –Patients of the control group received a tablet containing starch. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stage 2-4 hemorrhoidal disease;
- Presence of indications for elective surgery (open hemorrhoidectomy) using mono or bipolar coagulation possibly combined with other minimally invasive methods: hemorrhoidopexy and mucopexy, Ligasure hemorrhoidectomy;
- Absence of other diseases that cause pain;
- Class I, II ASA anesthesia risk;
Key exclusion criteria (4 listed)
- The presence of the following diseases: paraproctitis, inflammatory bowel disease, metabolic or endocrine disorders, alcoholism, drug use, blood clotting disorders, and history of diseases in the anorectal region;
- Contraindicated or technically impossible subarachnoid anesthesia;
- Patients who refused to participate;
- Pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| micronized flavonoid fractionPatients of the experimental group received Detralex® 1000 mg QD for 15 days before the operation, 3000 mg starting from day 1 after the surgery for 4 days, then 2000 mg for the next 3 days and 1000 mg till day 30 after surgery. Under spinal anesthesia appropriate surgical intervention was performed. After the surgery, the patient was given a questionnaire and a scale for assessing pain at rest and during defecation within the first 2 weeks after surgery. During the hospital stay, the nurse filled out a section on the drugs used; after discharge, the patient filled out this section for 7 days after the surgery. After 30 days, the side effects section was filled out, and the quality of life was assessed on days 7 and 30. Also, the patients indicated in a separate column on which day after the surgery they were able to return to normal living or go to work. | Drug | Experimental group |
Primary outcome
rate of prescribing opioid analgesics
Time frame: 7 days after surgery
the rate of prescribing opioid analgesics to prevent the pain from rising above VAS 5 after surgery
6 secondary outcomes
pain at rest and during defecation
Time frame: 15 days after surgery
other medications use
Time frame: 7 days after surgery
readmission rate
Time frame: 30 days after surgery
The life quality rate
Time frame: 7 and 30 days
time from surgery to return to work
Time frame: during 30 days after surgery
complication rates
Time frame: within 30 days after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing micronized flavonoid fraction in people with Hemorrhoids and Hemorrhoid Pain, run by Center of Endourology "Endocenter" at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of prescribing opioid analgesics (time frame: 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.