Wellbeing and recovery of women after a hysterectomy Surgery Acquired absence of genital organ(s)
Conditions
Interventions
Patients are randomly and blindly divided into two arms (1:1 ratio) – Robuvit? and placebo groups. Robuvit® is a registered trademark of Horphag Research. Placebo contained magnesium stearate, silicon
Sponsors
Comenius University, Faculty of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Undergoing hysterectomy for benign indications such as meno/metrorrhagia or uterine prolapse. Preoperatively, the patients did not take any analgesics or other drugs related to the symptomatology 2. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Currently enrolled in another study. 2. Malignant disease, severe systemic disease, chronic autoimmune diseases. 3. Significant psychiatric disorders or receiving antipsychotic drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mental and physical wellbeing is measured using validated standardized questionnaire SF-36 at the baseline (before surgery) and after weeks 4 and 8 of intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Biochemical parameters (glucose, creatinine, uric acid, total proteins, triacylglycerols, total cholesterol, LDL- and HDL-cholesterols an hsCRP) are measured using standard biochemical procedures in Medirex servis, s.r.o. Bratislava at the baseline and after week 8 of intervention. 2. Markers of oxidative stress (markers of lipid damage - lipoperoxides, protein damage - AOPP, total antioxidant status as TEAC and on the activities and the levels of MMP-2 and MMP-9) are measured using the following methods: 2.1. The antioxidant capacity of plasma was determined with the TEAC method (trolox equivalent antioxidant capacity) on the Hitachi 911 automated analyser using the Randox set (United Kingdom). Antioxidant activity was expressed in nmol trolox/mL of plasma (Re et al., 1999). 2.2. Lipid hydroperoxides (LPx) in blood serum were determined according to El-Saadani et al. (1989), advanced oxidation protein products (AOPP) according to the modified Witko-Sarsat et al. (1998). 2.3. The gelatinolytic activities of metalloproteinases (MMPs) were analyzed in plasma by zymography in 10% polyacrylamide gels containing gelatin (Giannakos et al., 2019). Protein level of MMPs was determined by Western blot analysis (Bartekova et al., 2015). 2.4. Investigation of metabolites of Robuvit in serum/blood cells which should be formed in GIT from the original molecules present in Robuvit and determination of potential biological activities. | — |
Countries
Slovakia
Outcome results
None listed