scholarly journals Effect of Biofeedback Therapy during Temporary Stoma Period in Rectal Cancer Patients: A Prospective Randomized Trial

2021 ◽  
Vol 10 (21) ◽  
pp. 5172
Author(s):  
Hyeon-Min Cho ◽  
Hyungjin Kim ◽  
RiNa Yoo ◽  
Gun Kim ◽  
Bong-Hyeon Kye

Background: This prospective randomized controlled study was designed to evaluate the effect of biofeedback therapy (BFT) during temporary stoma period to prevent defecation dysfunction after sphincter-preserving surgery (SPS). Methods: Following SPS with temporary stoma, patients were divided according to whether (BFT group) or not (Control group) they received BFT. BFT was performed once or twice a week during the temporary stoma period. Kegel exercise were advised to all the patients. Subjective defecation symptoms were evaluated according to Cleveland Clinic Incontinence Score (CCIS) as primary outcome at 12 months postoperatively. Manometric data of five time-points were also analyzed. Results: Twenty-one patients in the BFT group and 23 patients in the control group received anorectal physiologic testing. The incidence of CCIS of more than 9 points, which is the primary end point in this study, was not statistically different between BFT group and control group (p = 1.000). The liquid stool incontinence in the BFT group showed a better tendency (p = 0.06) at 12 months post-SPS. Time-dependent serial changes in maximal sensory threshold (Max RST) was significantly different between the BFT and control groups (p = 0.048). Also, the change of mean resting pressure (MRP) tended to be more stable in the BFT group (p = 0.074). Conclusions: The BFT in the period of temporary stoma may be related to liquid stool incontinence at 12 months post-SPS and lead to stable MRP and better Max RST. Therefore, BFT during temporary stoma might be helpful for preventing and minimizing defecation dysfunction in high risk patients after SPS, NCT01661829).

Author(s):  
Changying Yi ◽  
Jie Zhang ◽  
Meili Fan

<B>Objective:</B> Functional fecal incontinence in children (FFIC), also known as functional fecal disorder in children, is a type of childhood diseases characterized by excretory dysfunction. In the study, we observed the clinical effect of Changqiang acupoint injection on functional fecal incontinence in children (FFIC) by randomized controlled clinical trials. <BR><B>Materials and methods:</B> 140 children with functional fecal incontinence who met the screening criteria were respectively assigned into the treatment group (100 cases) and the control group (40 cases) according to the completely randomized controlled design. In the treatment group, Chuankezhi injection was administrated at the Changqiang acupoint once a week for three weeks (one course of treatment). In contrast, the subjects in the control group was instructed to receive sphincter exercise and defecation training, followed by an assessment on the therapeutic efficacy after one course of treatment. <BR><B>Results:</B> The overall response rate of the two groups was 93.00% (93/100) and 57.50% (23/40), respectively, with a statistically significant difference (P<0.01). The treatment group showed a performance superior to the control group based on the Cleveland Clinic Florida Fecal Incontinence Score System (CCF-FI)—dry stool incontinence, liquid incontinence, gas incontinence, lifestyle change, necessity of using pads or antidiarrheals, the ability to delay defecation, and the total score. The inter-group comparison revealed a statistically significant difference (P<0.01). <BR><B>Conclusion:</B>Changqiang acupoint injection has significant curative effect on FFIC as demonstrated by significant relief in the symptoms associated with fecal incontinence, and thus is considered as a useful approach to be widely applied in clinical practice.


2021 ◽  
Vol 27 (1) ◽  
Author(s):  
Shabieb A. Abdelbaki ◽  
Adel Al-Falah ◽  
Mohamed Alhefnawy ◽  
Ahmed Abozeid ◽  
Abdallah Fathi

Abstract Background Perioperative bleeding is the most common complication related to transurethral resection of prostate; the aim of the study was to compare the effect of pre-operative use of finasteride versus cyproterone acetate (CPA) on blood loss with monopolar TURP. Methods This prospective randomized controlled study was conducted on (60) patients with BPH underwent monopolar TURP between July 2019 and July 2020. Patients were distributed into three equal groups; CPA group: 20 patients received cyproterone acetate 50 mg tab BID for two weeks before TURP, finasteride group: 20 patients received single daily dose of finasteride 5 mg for two weeks before TURP, control group: 20 patients received no treatment before TURP, all patients underwent monopolar TURP, and then histopathological examination of the resected tissues was done with assessment of the microvascular density of the prostate. Results Our study showed that there was significant decrease in intraoperative blood loss and operative time in CPA and finasteride groups in comparison with control group (p = 0.0012) (p < 0.0001), respectively, significant decrease in post-operative Hb and HCT value in finasteride and control groups in comparison with CPA group (p < 0.01), significant increase in specimen weight in CPA group compared to other groups (p < 0.01), and there was also significant decrease in microvascular density in CPA group in comparison with other groups (p < 0.01). Conclusion Cyproterone acetate is more effective than finasteride in decreasing perioperative bleeding with TURP by decreasing microvascular density of the prostate.


2018 ◽  
Vol 2018 ◽  
pp. 1-15
Author(s):  
Ranran Chen ◽  
Dianrong Song ◽  
Wei Zhang ◽  
Guanwei Fan ◽  
Yingqiang Zhao ◽  
...  

Objective. To evaluate the clinical therapeutic efficacy and safety of modified Erzhi granules (MEG) in patients with menopause-related vulvovaginal atrophy (VVA). Methods. This randomized, double-blind, placebo-controlled study comprised two groups, including the treatment and control groups. Patients receive MEG and placebo for 12 weeks, respectively. Vaginal health score (VHS), vaginitis score, vaginal maturation index (VMI), female sexual function index (FSFI), and modified Kupperman Index (modified KI) were used as efficacy endpoints and assessed at baseline, 4, 8, and 12 weeks during administration, and 4 weeks after drug withdrawal. At baseline and 12 weeks, serum estradiol (E2), follicle stimulating hormone (FSH), pelvic ultrasound, breast ultrasound, and other safety parameters were measured, recording adverse events. Results. At 12 weeks, VHS, percentage of superficial cells in the vaginal epithelium and FSFI were significantly increased, while vaginitis score, percentage of basal cells in the vaginal epithelium, and modified KI were significantly decreased in comparison with baseline and control group (all P<0.05); these differences persisted for up to 4 weeks after drug withdrawal. The placebo group showed no significant change during treatment compared with baseline values (p>0.05). Serum E2 and FSH levels, endometrial thickness, and breast thickness in all patients were within the normal ranges before and after treatment, with no serious adverse reactions observed. Conclusion. MEG significantly alleviates menopause-related vulvovaginal atrophy, with no overt adverse effects on the endometrium, breast, hepatic, and renal functions.


2020 ◽  
Vol 19 ◽  
pp. 153473542092483
Author(s):  
Yan Mei Peng ◽  
Hua Duan ◽  
Jingyi Zhang ◽  
Chenyao Sun ◽  
Xu Zhang ◽  
...  

Background: Dermatologic toxicities are the most common side effects associated with the targeted drugs epidermal growth factor receptor inhibitors (EGFRIs), in which xerosis commonly complicated by pruritus severely disturbs the quality of life. The study has observed the curative effect of Zizao Yangrong granules (ZYG) from Chishui Xuanzhu in the treatment of EGFRIs-related xerosis and pruritus, as well as evaluating the safety of the prescription. Methods: Patients (n = 68) who had xerosis after using EGFRIs were enrolled and then randomly divided into the treatment group and control group, respectively, receiving ZYG and placebo granules combined with vitamin E ointment. The intervention lasted 4 weeks. Changes in xerosis and pruritus were observed, and blood routine examination as well as liver and kidney function are observed as safety indexes. The water content of skin and qualify of life were observed. Results: A total of 66 out of 68 patients finished the study with 34 patients in each group. The effective rates of xerosis among the treatment group and control group were 84.8% and 69.7% after 2 weeks’ treatment ( P < .05), while they were 84.8% and 75.8% after 4 weeks’ treatment ( P < .05). The patients in the experimental group had better quality of life than that in the control group ( P = .045). Conclusion: ZYG can effectively improve the skin dryness associated with EGFRIs, and significantly improve the quality of life of patients with good safety; however, larger randomized controlled trials are needed to verify these findings.


2020 ◽  
pp. postgradmedj-2020-139065 ◽  
Author(s):  
Ashu Rastogi ◽  
Anil Bhansali ◽  
Niranjan Khare ◽  
Vikas Suri ◽  
Narayana Yaddanapudi ◽  
...  

BackgroundVitamin D has an immunomodulatory role but the effect of therapeutic vitamin D supplementation in SARS-CoV-2 infection is not known.AimEffect of high dose, oral cholecalciferol supplementation on SARS-CoV-2 viral clearance.DesignRandomised, placebo-controlled.ParticipantsAsymptomatic or mildly symptomatic SARS-CoV-2 RNA positive vitamin D deficient (25(OH)D<20 ng/ml) individuals.InterventionParticipants were randomised to receive daily 60 000 IU of cholecalciferol (oral nano-liquid droplets) for 7 days with therapeutic target 25(OH)D>50 ng/ml (intervention group) or placebo (control group). Patients requiring invasive ventilation or with significant comorbidities were excluded. 25(OH)D levels were assessed at day 7, and cholecalciferol supplementation was continued for those with 25(OH)D <50 ng/ml in the intervention arm. SARS-CoV-2 RNA and inflammatory markers fibrinogen, D-dimer, procalcitonin and (CRP), ferritin were measured periodically.Outcome measureProportion of patients with SARS-CoV-2 RNA negative before day-21 and change in inflammatory markers.ResultsForty SARS-CoV-2 RNA positive individuals were randomised to intervention (n=16) or control (n=24) group. Baseline serum 25(OH)D was 8.6 (7.1 to 13.1) and 9.54 (8.1 to 12.5) ng/ml (p=0.730), in the intervention and control group, respectively. 10 out of 16 patients could achieve 25(OH)D>50 ng/ml by day-7 and another two by day-14 [day-14 25(OH)D levels 51.7 (48.9 to 59.5) ng/ml and 15.2 (12.7 to 19.5) ng/ml (p<0.001) in intervention and control group, respectively]. 10 (62.5%) participants in the intervention group and 5 (20.8%) participants in the control arm (p<0.018) became SARS-CoV-2 RNA negative. Fibrinogen levels significantly decreased with cholecalciferol supplementation (intergroup difference 0.70 ng/ml; P=0.007) unlike other inflammatory biomarkers.ConclusionGreater proportion of vitamin D-deficient individuals with SARS-CoV-2 infection turned SARS-CoV-2 RNA negative with a significant decrease in fibrinogen on high-dose cholecalciferol supplementation.Trial register numberNCT04459247.


2015 ◽  
Vol 1 (4) ◽  
pp. 199
Author(s):  
Angel Rajakumari G ◽  
Soli T. K ◽  
Malathy D

Aim: To evaluate the effectiveness of meditation lowers stress and supports forgiveness among nursing Students.Participants and setting: The study was conducted by adopting a Quasi-experimental, non-equivalent control group pre and post test design.50 nursing students who fulfilled the inclusion criteria were selected by using Non-probability purposive sampling technique. 50 women were assigned in experimental and control group. The study was conducted in Bhavana College of nursing, Nalgonda, Telugana, India.Intervention: A brief introduction about self and study was given to the nursing students and consent was obtained (both oral and written) and the confidentiality of the response was assured. Pre assessment was done in both experimental and control groups. In the experimental group meditation technique was practiced by the women and pre and post test level of stress was obtained using John D. Catherine & T. Mac Arthurs perceived stress scale. In the control group without any intervention, the pre and post test level of stress was obtained for both the groups and the level of stress was assessed.Measurement and findings: Analysis revealed that the women in the experimental group showed a highly significant decrease in the level of stress following meditation at P<0.001 level when compared with the control group.Conclusion: Evidence suggests that meditation-based stress-management practices reduce stress and enhance forgiveness among college undergraduates. Such programs merit further study as potential health-promotion tools for college populations.


2020 ◽  
Vol 40 (9) ◽  
pp. NP499-NP510 ◽  
Author(s):  
Patricia Ogilvie ◽  
Laurence Benouaiche ◽  
Wolfgang G Philipp-Dormston ◽  
Lakhdar Belhaouari ◽  
Frodo Gaymans ◽  
...  

Abstract Background Juvéderm Volux (VYC-25L; Allergan plc) is an injectable hyaluronic acid gel designed to restore and create facial volume. Objective The aim of this study was to evaluate the safety and effectiveness of Volux for chin retrusion over 18 months and after repeat treatment. Methods This prospective, single-blind, controlled study enrolled subjects aged ≥18 years with chin retrusion (glabella-subnasale-pogonion facial angle 145°-165°). Subjects were randomized (3:1) to Volux at study onset or 3 months later (control group), and could receive a single repeat treatment during months 18 to 24. Assessments included mean facial-angle change from baseline, Global Aesthetic Improvement Scale (GAIS) responder rates (improved/much improved), improvements in 3 subject-reported FACE-Q scales, and safety. Results Of 132 enrolled subjects, 119 received initial Volux treatment and 89 received repeat treatment. Mean changes (95% confidence interval) in glabella-subnasale-pogonion angle from baseline for treatment and control groups, respectively, were: 1.15° (0.75°, 1.56°) and 1.16° (0.57°, 1.75°) at month 18, and 3.14° (2.68°, 3.61°) and 2.72° (1.78°, 3.66°) 1 month after repeat treatment. Investigators rated 52.5%/60.0% of treated/control subjects at month 18 and 96.9%/100% after retreatment as GAIS responders; subject-reported rates were 62.0%/64.0% and 93.8%/100%. Durable improvements in Satisfaction with Chin, Satisfaction with Lower Face and Jawline, and Psychological Well-Being were reported in 82.1%, 78.2%, and 60.3% of subjects, respectively, at month 18, and 92.3%, 93.8%, and 67.7% of subjects after retreatment. The safety profile was as expected. Conclusions Volux injectable gel is a safe, effective, and durable alternative to surgical treatments for increasing chin projection and jaw volume, and results in high patient satisfaction. Level of Evidence: 2


2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Dmytro Ivanov ◽  
Mariia Ivanova ◽  
Illia Burlachenko

Abstract Background and Aims Edaravone is a low-molecular-weight antioxidant drug targeting peroxyl radicals of reactive oxygen species and has shown clinical efficacy in patients with acute ischemic stroke. We have conducted a multicenter open prospective randomized controlled study to evaluate the efficacy of edaravone in preventing AKI in patients with CKD 3b-4 stages. Method The study included 2 groups of patients aged 46 to 68 (55 ± 3): group A (n=16) with CKD stage 3b or 4 (eGFR EPI 32 ± 4 ml/min) that received intravenous edaravone 30 mg bid on 0,1,2 day of contrast media infusion and control group B (n=20) with CKD stage 3b or 4 (eGFR EPI 33 ± 3 ml/min) with no edaravone intervention during CT coronarography. Patients of both groups received intravenous hydration with 0.9% sodium before CT. Primary endpoint: CIN onset in 48 hours after contrast media infusion and need for RRT. Secondary endpoint: serum potassium level above 5.5 mmol/l. Results CIN onset was obtained in 4 patients of group A and 12 patients of group B (p&gt;0,05, RR 0.417, RRR 0.583, RD 0.350, NNT 2.857). Other results are presented in table


Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 4591-4591
Author(s):  
Selim Corbacioglu ◽  
Simone Cesaro ◽  
Maura Faraci ◽  
Bernd Gruhn ◽  
Jaap J Boelens ◽  
...  

Background Acute GvHD (aGvHD) remains one of the most significant complications of allogeneic hematopoietic stem cell transplantation (HSCT) with a persistently high incidence despite a plethora of prophylactic approaches. The medical need for effective drugs to prevent aGvHD remains substantial. Methods A prospective, randomized, open-label controlled study has been conducted in 356 children at high-risk for hepatic VOD post-HSCT to demonstrate efficacy of prophylaxis with defibrotide (DF) to reduce the incidence of VOD (180 in the DF arm and 176 in the control arm [Corbacioglu, Lancet 2012]). A secondary objective of the study was to analyze the impact of DF prophylaxis on the incidence and severity of aGvHD. Among children undergoing allogeneic HSCT (allo-subset) 122 patients received DF prophylaxis and 117 were in the control arm. Results Demographic and baseline characteristics were similar in the DF and control arm of the allo-subset. Mean age (± SD) was 6.47±5.28 and 6.54±5.49 in DF arm and in the controls respectively, with 29% and 30% being <2 years; 64% and 58%, respectively, were males. Busulfan was used in conditioning in 62% and 64% of patients in the two arms, and melphalan in 60% and 53%, respectively. Grafts were from related donors in 40% and 30%, respectively, in DF and control arm. Prophylaxis with DF was shown to significantly reduce the occurrence and severity of aGvHD. At day+100 post-HSCT the incidence of aGvHD was 47% in the DF arm vs. 65% in the control group (p=0.0046). DF did not seem to affect the incidence of aGvHD grade I (25% vs 28%, respectively). However, Defibrotide showed a consistent reduction of the more severe grade II–IV aGvHD from 37% to 22% (p=0.0130). Of note the use of corticosteroids was significantly lower in patients receiving DF prophylaxis (37% vs 48% in control arm, p=0.0363), likely reflecting the lower incidence of aGvHD in the DF arm. This has also previously been observed in the treatment studies [Richardson, ASH 2012]. Standard GvHD prophylaxis was allowed according to best practice and was generally comparable (cyclosporine A: 81% vs. 89%; methotrexate: 46% vs. 56%; in DF and control arm, respectively). However, there was a difference in patients who received antithymocyte globulin (ATG) in the DF arm compared to controls (55% vs 70%). Exploratory analysis performed adjusting for ATG as covariate confirmed the significant effects of defibrotide [Adjusted Risk Difference (DF vs control) for aGvHD grade II–IV: -0.1470 (95%CI: -0.2618; -0.0322), p =0.0121]. Defibrotide did not seem to interfere with a graft-versus-leukemia effect. Relapse rates of combined leukemias were 8% (ALL 1.5%, AML 5%, others 1.5%) in DF group compared with 10% (ALL 3%, AML 7%) in controls by day +100; while 10% (ALL 1.5%, AML 7%, others 1.5%) patients in DF group relapsed by day +180 compared with 13% (ALL 8%, AML 5%) in the control arm. Conclusions The study shows that DF prophylaxis can reduce the incidence and severity of aGvHD in children undergoing allogeneic HSCT. This reduction observed with defibrotide is additional to standard GvHD prophylaxis that was fully implemented in these patients. Defibrotide has been reported to protect endothelial cells from damage as well as to downregulate heparanase activity. These clinical data would therefore suggest a benefit of defibrotide to reduce the incidence and severity of aGvHD. Further studies may be conducted to strengthen preclinical and clinical evidence for the role of defibrotide in aGvHD prevention. Ref: Corbacioglu S et al, Lancet 2012; 379:1301-9. Richardson PG et al, Blood 2012; 120:738. Disclosures: Corbacioglu: Gentium : Consultancy. Cesaro:Pfizer SpA: Honoraria; Gilead: Honoraria; Merck: Honoraria. Tudone:Gentium : Employment. Ballabio:Gentium : Employment. Heringa:Gentium S.p.A.: Employment.


Angiology ◽  
2001 ◽  
Vol 52 (3_suppl) ◽  
pp. S29-S34 ◽  
Author(s):  
M.T. De Sanctis ◽  
L. Incandela ◽  
G. Belcaro ◽  
M.R. Cesarone

The involvement of the microcirculation in chronic venous insufficiency (CVI), due to venous hypertension, causes venous hypertensive microangiopathy (VHM) and ulceration. VHM is char acterized by enlarged, convoluted capillaries; microvascular thrombosis; obliteration of some capillaries; increase in flux, permeability, and edema and altered microlymphatics. PO 2 is decreased and CO2 increased. Capillary exchanges are altered and nutritional alterations even tually lead to venous ulcers. Edema is associated with increased capillary pressure, reduced clearance, and increased exchange surface of capillaries, which become tortuous and glomerular-like. The aim of this randomized, placebo-controlled study was to evaluate local treatment with Essaven gel (EG) in subjects with venous microangiopathy and ulcers. Measurements of laser Doppler flux, PO2, and PCO2 in standardized conditions showed positive changes (a significant decrease of the abnormally increased flux and CO2 while PO2 increased) in the EG treatment group. Changes in the placebo and control group were more limited (changes in the placebo group were mainly associated with skin manipulation when placebo- EG was applied). In conclusion, Essaven gel, in comparison with placebo, acutely improves the microcirculation in VHM even with a single acute application.


Sign in / Sign up

Export Citation Format

Share Document