Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05772351
Status:
COMPLETED
Last Update Posted:
2023-08-24
First Post:
2023-03-06
Brief Title:
Preoperative Micronized Flavonoid Fraction MFF Use in Multimodal Anesthesia in Anorectal Surgery
Sponsor:
Center of Endourology Endocenter
Organization:
Center of Endourology Endocenter
Study Overview
Official Title:
Preoperative Micronized Flavonoid Fraction MFF Use in Multimodal Anesthesia in Anorectal Surgery Study Protocol for Prospective Randomized Placebo-controlled Double-blind Study
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None