Preoperative Micronized Flavonoid Fraction (MFF) Use in Multimodal Anesthesia in Anorectal Surgery

Hemorrhoids Clinical Trial

Official title:

Preoperative Micronized Flavonoid Fraction (MFF) Use in Multimodal Anesthesia in Anorectal Surgery: Study Protocol for Prospective, Randomized, Placebo-controlled, Double-blind Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05772351
• Other study ID #: 5995465475
• Status: Completed
• Phase: N/A
• Start date: November 25, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: August 2023
• Source: Center of Endourology "Endocenter"
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Hemorrhoid Pain
• Hemorrhoids

Intervention

Drug:
• micronized flavonoid fraction
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.

Locations

Country	Name	City	State
Russian Federation	Lomonosov Moscow State University, Fundamental Medicine Faculty	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Center of Endourology "Endocenter"

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of prescribing opioid analgesics	the rate of prescribing opioid analgesics to prevent the pain from rising above VAS 5 after surgery	7 days after surgery
Secondary	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).	15 days after surgery
Secondary	other medications use	the need for other medications after surgery	7 days after surgery
Secondary	readmission rate		30 days after surgery
Secondary	The life quality rate	The overall quality of life was assessed using the EQ-5D patient questionnaire.	7 and 30 days
Secondary	time from surgery to return to work		during 30 days after surgery
Secondary	complication rates	bleeding, urinary retention, infectious complications	within 30 days after the procedure