scholarly journals A Prospective and Controlled Clinical Trial on Stromal Vascular Fraction Enriched Fat Grafts in Secondary Breast Reconstruction

2016 ◽  
Vol 2016 ◽  
pp. 1-12 ◽  
Author(s):  
L. A. L. Tissiani ◽  
N. Alonso
Keyword(s):  
Breast Reconstruction ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Stromal Vascular Fraction ◽  
Cell Counting ◽  
Fat Graft ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Fat Grafts ◽  
Significant Difference

Background.Fat grafting is a tremendous tool in secondary breast reconstruction. Stromal vascular fraction (SVF) enriched fat grafts have been presenting promising results regarding volume maintenance.Methods.We developed a method that produces a superior SVF enrichment rate (2 : 1) in the operating theatre. This prospective and controlled trial analyzed quantitatively and qualitatively fat grafts with (stem cells group, SG) and without (control group, CG) SVF enrichment in secondary breast reconstruction, through MRI-based volumetry, immunophenotyping, and cell counting. Also, patient satisfaction, aesthetic outcomes, and complications were analyzed.Results.Volumetric persistence in the SG was 78,9% and 51,4% in the CG; however it did not reach statistical significant difference. CD90 was the only marker highly expressed in the SG and showed a positive correlation with volumetric persistence (r=0.651,p=0.03). Fat necrosis occurred in 4 patients in the SG and in none in the CG. Patients in the CG showed a trend to be more satisfied. Considering aesthetics, both groups presented improvements. No locoregional recurrences were observed.Conclusions.Results are encouraging despite the fact that SVF enrichment in a higher supplementation rate did not improve, with statistical significance, fat graft volumetric persistence. Enriched fat grafts have proven to be safe in a 3-year follow-up.

scholarly journals Engineered Fat Graft Enhanced with Adipose-Derived Stromal Vascular Fraction Cells for Regenerative Medicine: Clinical, Histological and Instrumental Evaluation in Breast Reconstruction

2019 ◽  
Vol 8 (4) ◽  
pp. 504 ◽  
Author(s):  
Pietro Gentile ◽  
Donato Casella ◽  
Enza Palma ◽  
Claudio Calabrese
Keyword(s):  
Breast Reconstruction ◽  
Preoperative Evaluation ◽  
Three Dimensional ◽  
Stromal Vascular Fraction ◽  
Fat Graft ◽  
Control Group ◽  
Study Group ◽  
Fat Tissue ◽  
Calvarial Defects

The areas in which Stromal Vascular Fraction cells (SVFs) have been used include radiotherapy based tissue damage after mastectomy, breast augmentation, calvarial defects, Crohn’s fistulas, and damaged skeletal muscle. Currently, the authors present their experience using regenerative cell therapy in breast reconstruction. The goal of this study was to evaluate the safety and efficacy of the use of Engineered Fat Graft Enhanced with Adipose-derived Stromal Vascular Fraction cells (EF-e-A) in breast reconstruction. 121 patients that were affected by the outcomes of breast oncoplastic surgery were treated with EF-e-A, comparing the results with the control group (n = 50) treated with not enhanced fat graft (EF-ne-A). The preoperative evaluation included a complete clinical examination, a photographic assessment, biopsy, magnetic resonance (MRI) of the soft tissue, and ultrasound (US). Postoperative follow-up took place at two, seven, 15, 21, 36 weeks, and then annually. In 72.8% (n = 88) of breast reconstruction treated with EF-e-A, we observed a restoration of the breast contour and an increase of 12.8 mm in the three-dimensional volume after 12 weeks, which was only observed in 27.3% (n = 33) of patients in the control group that was treated with EF-ne-A. Transplanted fat tissue reabsorption was analyzed with instrumental MRI and US. Volumetric persistence in the study group was higher (70.8%) than that in the control group (41.4%) (p < 0.0001 vs. control group). The use of EF-e-A was safe and effective in this series of treated cases.

scholarly journals Randomized Controlled Clinical Trial Comparing Transurethral Eneucleation and Resection of Prostate and Trans-urethral Resection of Prostate in the Management of Benign Prostatic Hyperplasia

2017 ◽  
Vol 7 (3) ◽  
pp. 216-220
Author(s):  
Md Mehedi Hasan ◽  
Samira Rahat Afroze ◽  
Muhammad Abdur Rahim ◽  
Muhammad Abdus Salam
Keyword(s):  
Controlled Trial ◽  
Ethical Review ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Transurethral Resection Of Prostate ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Group A ◽  
The Mean ◽  
Group B

Background: Transurethral resection of prostate (TURP) is the predominant surgical procedure for benign prostatic hypertension (BPH) but is not devoid of complications like capsular perforation, drop in Hb%, drop in Na+, residual adenoma; hence endeavors are evolving to combat such complications. A newer technique transurethral enucleation and resection of prostate (TUERP) has been devised to solve these problems. This study was designed to compare the safety and the efficacy of newer technique, TUERP with widely practiced TURP Methods: This randomized controlled trial was done at BSMMU, after getting ethical approval from the ethical review committee of the institute, from January to October, 2009. A total of 60 BPH patients were purposively enrolled in this study, after obtaining informed written consent and they were randomized as control, Group A (30 patients, underwent TURP) and experimental group, Group B (30 patients, underwent TEURP).Results: The mean preoperative Hb% level of Group A was 15.1 gm% (SD ± 0.5) and perioperative Hb% level was 13.04 gm% (SD ± 6.06). There was significant difference (P <0.05). The mean preoperative Hb% of Group B was 15.2 gm% (SD ± 0.5) and perioperative Hb% was 15.2 gm% (SD ± 0.48). There was no difference (P >0.05). The mean preoperative Na + of Group A was 140 mmol/l (SD ± 4.1) and perioperative Na+ was 126 mmol/l (SD ± 6.8). There was significant difference (P<0.01). The mean preoperative Na+ of Group B was 136 mmol/l (SD ± 4) and perioperative Na+ was 136 mmol/l (SD ± 2.70). There was no difference (P >0.05).Conclusion: TUERP eliminates drop in Hb% and Na+which are usual consequences following TURP. Thus TUERP can be advocated in the treatment of BPH as it also allows completeresection down to surgical capsule.Birdem Med J 2017; 7(3): 216-220

scholarly journals Effects of Peer-Facilitated, Video-Based and Combined Peer-and-Video Education on Anxiety Among Patients Undergoing Coronary Angiography: Randomised controlled trial

2018 ◽  
Vol 18 (1) ◽  
pp. 61 ◽  
Author(s):  
Hosein Habibzadeh ◽  
Zahra D. Milan ◽  
Moloud Radfar ◽  
Audrey Cund
Keyword(s):  
Coronary Angiography ◽  
Controlled Trial ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Patient Anxiety ◽  
Post Intervention ◽  
Persian Language ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Video Education

Objectives: Coronary angiography can be stressful for patients and anxiety-caused physiological responses during the procedure increase the risk of dysrhythmia, coronary artery spasms and rupture. This study therefore aimed to investigate the effects of peer, video and combined peer-and-video training on anxiety among patients undergoing coronary angiography. Methods: This single-blinded randomised controlled clinical trial was conducted at two large educational hospitals in Iran between April and July 2016. A total of 120 adult patients undergoing coronary angiography were recruited. Using a block randomisation method, participants were assigned to one of four groups, with those in the control group receiving no training and those in the three intervention groups receiving either peer-facilitated training, video-based training or a combination of both. A Persian-language validated version of the State-Trait Anxiety Inventory was used to measure pre- and post-intervention anxiety. Results: There were no statistically significant differences in mean pre-intervention anxiety scores between the four groups (F = 0.31; P = 0.81). In contrast, there was a significant reduction in post-intervention anxiety among all three intervention groups compared to the control group (F = 27.71; P <0.01); however, there was no significant difference in anxiety level in terms of the type of intervention used. Conclusion: Peer, video and combined peer-and-video education were equally effective in reducing angiography-related patient anxiety. Such techniques are recommended to reduce anxiety amongst patients undergoing coronary angiography in hospitals in Iran.

Aromatherapy reduces fatigue among women with hypothyroidism: A randomized placebo-controlled clinical trial

2019 ◽  
Vol 17 (1) ◽  
Author(s):  
Jessie Hawkins ◽  
Christy Y. Hires ◽  
Elizabeth W. Dunne ◽  
Lindsey A. Keenan
Keyword(s):  
Clinical Trial ◽  
Primary Outcome ◽  
Statistical Significance ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
General Fatigue ◽  
Significant Difference ◽  
History Of ◽  
Oil Blend ◽  
Validated Instrument

AbstractBackgroundThis randomized, blinded, placebo-controlled clinical trial identifies the effect of an aromatherapy blend of essential oils on fatigue, which is one of the most commonly unaddressed symptoms of hypothyroidism, by evaluating the effects of daily aromatherapy inhalation.MethodsParticipants included women aged 18–55 with a diagnosis of hypothyroidism. Women who had a history of thyroid cancer were excluded, due to the confounding effects of cancer on fatigue as the outcome of interest. Participants were randomized into two groups: the aromatherapy group, treated with inhalation of the essential oil blend, and the control group, treated with an odorless vegetable oil blend. The primary outcome was change from baseline in fatigue scores as measured by the Multidimensional Fatigue Symptom Inventory (MFSI), a validated instrument which measures multiple patterns of fatigue.ResultsAfter adjusting for baseline scores, no significant difference was found between the aromatherapy group and the control group at midpoint. Both groups experienced a reduction in symptoms during the first week of the intervention. At the endpoint, participants in the aromatherapy group had improved fatigue scores across all ten subscales, as compared to the control group. Not all improvements achieved statistical significance, indicating that the aromatherapy treatment has a greater effect on the subscales of global, affective, and general fatigue.ConclusionsThis is the first study to evaluate the effects of aromatherapy on fatigue among women with hypothyroidism. These findings provide evidence that regular inhalation of an aromatherapy blend may reduce fatigue among women with hypothyroidism, particularly in the areas of global, affective, and general fatigue.

scholarly journals Effects of a muscular stretching and strengthening school-based exercise program on posture, trunk mobility, and musculoskeletal pain among elementary schoolchildren - a randomized controlled trial

2019 ◽  
Vol 32 ◽  
Author(s):  
Mariana Vieira Batistão ◽  
Letícia Carnaz ◽  
Roberta de Fátima Carreira Moreira ◽  
Tatiana de Oliveira Sato
Keyword(s):  
Musculoskeletal Pain ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Intervention Group ◽  
Exercise Program ◽  
Control Group ◽  
School Based ◽  
Postural Changes ◽  
Significant Difference ◽  
Strengthening Exercises

Abstract Introduction: The exercise benefits for the most prevalent postural changes require proper investigation, with large samples, control group, and concealed allocation. Objective: To assess the effects of a muscular stretching and strengthening school-based exercise program on posture, trunk mobility, and musculoskeletal pain among elementary schoolchildren. Method: Three hundred students from three schools in Brazil were evaluated. Stretching and strengthening exercises, twice a week, for eight weeks in group sessions were provided by one physiotherapist. The control group did not undergo any intervention. Head, back and shoulder posture were qualitatively evaluated. Head and trunk alignment were evaluated using the Posture Assessment Software. Cervical, thoracic, low back and upper limb pain were assessed for the last seven days. The trunk mobility was recorded through the flexibility of the posterior chain. Posture, pain and trunk mobility were recorded at baseline and after the intervention. Groups were compared using χ2 test, two-way MANOVA, and two-way ANOVA, with α set at 5%. Results: Shoulder posture showed significant results (P = 0.04), the intervention group showed the lower worsening rate. In the quantitative evaluation, a statistically significant difference was observed between assessments (P < 0.01 for head and trunk; ES = 0.53) but not between groups. The intervention group had a higher percentage of improvement in the overall musculoskeletal pain (P = 0.04; ES = 0.54). Mobility decreased an average of 1.8° in the control group and increased 5.0° in the intervention group, without statistical significance. Conclusion: The program was effective in reducing pain level and shoulder misalignment at the intervention group.

scholarly journals The effectiveness of the robotic game kit on anxiety among hospitalized preschool children: A non-randomized controlled trial

2021 ◽  
Author(s):  
Sima Pourteimour ◽  
Sahar Kazemi
Keyword(s):  
Separation Anxiety ◽  
Controlled Trial ◽  
Intervention Group ◽  
Analysis Of Covariance ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Psychological Burden ◽  
Randomized Controlled ◽  
Significant Difference ◽  
The Mean

Background & Aim: Hospitalization is a challenging experience all children go through in their lives, leading to their utmost anxiety. In this sense, interactive games and activities can help ease this psychological burden. Therefore, we endeavored to determine the effectiveness of a robotic game kit (RGK) on the anxiety of hospitalized preschoolers. Methods & Materials: This non-randomized controlled clinical trial was conducted in a pediatric hospital, Iran, between March and July 2019. 59 participants were assigned to intervention (n=30) or control (n=29) groups through available sampling. Inclusion criteria were Iranian native children aged 3-7 years with communication ability. The RGK was applied in eight sessions at least seven consecutive days of hospitalization. The collected data by using the demographic information form and the preschool anxiety scale (PAS) were analyzed in descriptive, chi-square, t-test, the one-way ANCOVA (analysis of covariance), and multivariate analysis of covariance (MANCOVA). Results: Two groups were homogenous in terms of demographic variables (p>0.05). There was no statistically significant difference between the mean score of PAS before the intervention in the intervention 46.33±15.81 and control groups 37.24±19.65 (p=0.055). However, the mean score of PAS in the intervention group was significantly lower than the control group (P=0.030). Also, using the RGK was effective in two subscales related to separation anxiety and physical injury fears (P=0.034). Conclusion: The modern RGKs could have a significant place in pediatric health care in hospitals. It is thus an undeniable fact that high-quality, comprehensive care can be boosted through RGK based interventions for children encountering stressful situations.

scholarly journals The effect of counseling on fathers’ stress and anxiety during pregnancy: a randomized controlled clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Maryam Mohammadpour ◽  
Sakineh Mohammad-Alizadeh Charandabi ◽  
Jamileh Malakouti ◽  
Mehriar Nadar Mohammadi ◽  
Mojgan Mirghafourvand
Keyword(s):  
Perceived Stress ◽  
State Anxiety ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Expectant Fathers ◽  
And Control

Abstract Background Pregnancy is a challenging period for mothers and fathers. This study aimed to investigate the effect of counseling on stress and anxiety levels of fathers. Methods This randomized controlled trial was conducted on 102 spouses of pregnant women in Ardabil, Iran. The participants were randomly assigned to intervention and control groups. The intervention group attended four 60-min counseling sessions at weekly intervals. The perceived stress and anxiety questionnaires were completed before and 4 weeks after the intervention. Results The mean scores of state anxiety in the intervention group decreased significantly 4 weeks after the intervention compared with the control group (MD: -2.4; 95%CI: − 4.7 to − 0.2; p = 0.030). Four weeks after the intervention, no significant difference was found between the two groups in terms of trait anxiety (p = 0.472) and perceived stress (p = 0.635). Conclusions The findings indicate that counseling reduced state anxiety in expectant fathers; therefore, this intervention is recommended to be used to reduce fathers’ anxiety. Trial registration IRCT2017042910324N38. Registered 25 June 2017

scholarly journals Effect of Using a Plastic Stent with Apically Repositioned Flap in Peri-Implant Soft Tissue Augmentation: A Randomized Controlled Clinical Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-6
Author(s):  
Ahmed Hamdy ◽  
Hala K. Abd El Gaber ◽  
Dalia M. Ghalwash ◽  
Waleed M. Abbas
Keyword(s):  
Statistical Significance ◽  
Test Group ◽  
Soft Tissue Augmentation ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Stent Group ◽  
Plastic Stent ◽  
Keratinized Tissue ◽  
Significant Difference ◽  
Keratinized Mucosa

Objectives. This study aimed to clinically assess and compare the width of peri-implant keratinized mucosa following the use of a readymade plastic stent with apically repositioned flap versus conventional apically repositioned flap with papillary sparing incisions during single-stage implant placement protocol. Materials and Methods. A total of 20 patients were enrolled in this study. In the test group, a prefabricated implant-retained stent was clipped on the healing abutment after implant surgery to reposition the keratinized tissue buccoapically. In the control group, simple interrupted sutures were applied instead of using a stent. After the surgical procedure, the width of the buccal keratinized mucosa was measured at the mesial, middle, and distal aspects of the healing abutment. The change in the width of the buccal keratinized mucosa was assessed at 3 months and 6 months. Results. No statistically significant difference was found between the stent group and control group in 6 months’ interval where p = 0.840 , where both groups showed the same mean value of 4.70 ± 0.35 and 4.70 ± 0.63, respectively. The percent of change in the width of KM was found to be higher in the stent group than in the control group with no statistical significance. Conclusion. The use of a readymade plastic stent in combined full/partial-thickness apically repositioned flap shows to be effective in increasing the width of KM compared to the conventional technique. This trial is registered with NCT03754894.

Effect of Chewing Gum on Bowel Motility in Women Undergoing Post-Operative Cesarean Section

2018 ◽  
Vol 3 (06) ◽  
Author(s):  
Dr.Randa Mohammed AboBaker
Keyword(s):  
Cesarean Section ◽  
Hospital Stay ◽  
Demographic Data ◽  
Length Of Hospital Stay ◽  
Chewing Gum ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Bowel Motility ◽  
Gum Chewing ◽  
Significant Difference

Postoperative Ileus (POI) is one of the most common problems after obstetrics, gynecologic and abdominal surgeries. Sham feeding, such as gum chewing, accelerates the return of bowel function and the length of hospital stay. The present study aims to evaluate the effect of chewing gum on bowel motility in women undergoing post-operative cesarean section. Intervention study was used at the Postpartum Department of Maternity and Children Hospital, KSA. A randomized controlled clinical trial research design. Through a convenience technique, 80 post Caesarian Section (CS) women were included in the study. Data were collected through three tools: Tool (I): Socio-demographic data and reproductive history interview schedule. Tool (II): Postoperative Assessment Sheet. Tool (III): Outcomes of gum chewing and the length of hospital stay.  Method: subjects were assigned randomly into two groups of (40) the experimental and (40) the control. Subjects in the study group were asked to chew two pieces of sugarless gum for 30 min/three times daily in the morning, noon, and evening immediately after recovery from anesthesia and in Postpartum Department; while subjects in the control group followed the hospital routine care. Each woman in both groups was tested abdominally using a stethoscope to auscultate the bowel sounds and asked to report immediately the time of either passing flatus or stool. Results: illustrated that a highly statistically significant difference was observed between the two groups concerning their gum chewing outcomes. Where, P = 0.000. The study concluded that gum chewing is safe, well tolerated and appears to be effective in reducing the incidence and consequences of POI following CS.

Reducing the Social Stigma Associated with Obsessive Compulsive Disorder: A Controlled Trial of an Intervention Program in a Turkish Community Sample

2020 ◽  
Vol 20 (2) ◽  
pp. 101-120
Author(s):  
Ayça Aktaç Gürbüz ◽  
Orçun YORULMAZ ◽  
Gülşah DURNA
Keyword(s):  
Obsessive Compulsive Disorder ◽  
Intervention Program ◽  
Controlled Trial ◽  
Community Sample ◽  
Case Vignette ◽  
Control Group ◽  
Obsessive Compulsive ◽  
Compulsive Disorder ◽  
Significant Difference ◽  
The Impact

Scientific research into the reduction of stigmatization, particularly related to specific problems such as Obsessive-Compulsive Disorder (OCD), is scarce. In the present study, we examine the impact of a video-based antistigma intervention program for OCD in a pretest-posttest control group research. After being randomly assigned to either an intervention (n= 101) or control group (n= 96), the participants reported their attitudes on a hypothetical case vignette before and after OCD vs. Multiple Sclerosis (MS) videos, and again six months later as a follow up assessment. The mixed design analyses for the group comparisons indicated that although there was no significant difference in the measures of the control group, the participants watching the anti-stigma OCD video, in which the focus was psychoeducation and interaction strategies, reported significantly lower scores on social distances and negative beliefs for the case vignettes they read, and this difference was maintained six months later. Then, the present results indicate the effectiveness of our anti-stigma intervention program for OCD. Interventions to reduce stigmatization can also be viewed as effective tools for changing the attitudes of people toward OCD, although further research and applications are needed related to specific disorders if a longlasting impact is to be achieved.

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