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

NCT05772351 | Completed DMC

• 1 other identifier: 5995465475
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemorrhoids; Hemorrhoid Pain; Hemorrhoidal Bleeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• pain at rest and during defecation

  15 days after surgery

• other medications use

  7 days after surgery

• readmission rate

  30 days after surgery

• The life quality rate

  7 and 30 days

• time from surgery to return to work

  during 30 days after surgery

Study Arms (2)

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

Drug: micronized flavonoid fraction

Control group

NO INTERVENTION

Patients of the control group received a tablet containing starch.

Interventions

micronized flavonoid fraction DRUG

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.

Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Center of Endourology "Endocenter": lead

Study Sites (1)

Lomonosov Moscow State University, Fundamental Medicine Faculty

Moscow, 119991, Russia

Location

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 16, 2023
• Study Start: November 25, 2021
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)