scholarly journals Conservative treatment versus elective repair of umbilical hernia in patients with liver cirrhosis and ascites: results of a randomized controlled trial (CRUCIAL trial)

2020 ◽  
Author(s):  
B. de Goede ◽  
M. M. J. van Rooijen ◽  
B. J. H. van Kempen ◽  
W. G. Polak ◽  
R. A. de Man ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Liver Cirrhosis ◽  
Conservative Treatment ◽  
Umbilical Hernia ◽  
Controlled Trial ◽  
Number Of Patients ◽  
Umbilical Hernia Repair ◽  
Elective Repair

Abstract Purpose To establish optimal management of patients with an umbilical hernia complicated by liver cirrhosis and ascites. Methods Patients with an umbilical hernia and liver cirrhosis and ascites were randomly assigned to receive either elective repair or conservative treatment. The primary endpoint was overall morbidity related to the umbilical hernia or its treatment after 24 months of follow-up. Secondary endpoints included the severity of these hernia-related complications, quality of life, and cumulative hernia recurrence rate. Results Thirty-four patients were included in the study. Sixteen patients were randomly assigned to elective repair and 18 to conservative treatment. After 24 months, 8 patients (50%) assigned to elective repair compared to 14 patients (77.8%) assigned to conservative treatment had a complication related to the umbilical hernia or its repair. A recurrent hernia was reported in 16.7% of patients who underwent repair. For the secondary endpoint, quality of life through the physical (PCS) and mental component score (MCS) showed no significant differences between groups at 12 months of follow-up (mean difference PCS 11.95, 95% CI − 0.87 to 24.77; MCS 10.04, 95% CI − 2.78 to 22.86). Conclusion This trial could not show a relevant difference in overall morbidity after 24 months of follow-up in favor of elective umbilical hernia repair, because of the limited number of patients included. However, elective repair of umbilical hernia in patients with liver cirrhosis and ascites appears feasible, nudging its implementation into daily practice further, particularly for patients experiencing complaints. Trial registration Clinicaltrials.gov, NCT01421550, on 23 August 2011.

scholarly journals Improving the quality of life of patients with breast cancer-related lymphoedema by lymphaticovenous anastomosis (LVA): study protocol of a multicentre randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. e035337 ◽  
Author(s):  
Joost Wolfs ◽  
Jop Beugels ◽  
Merel Kimman ◽  
Andrzej A Piatkowski de Grzymala ◽  
Esther Heuts ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Lymph Node ◽  
Randomised Controlled Trial ◽  
Conservative Treatment ◽  
Cancer Treatment ◽  
Controlled Trial ◽  
Breast Cancer Treatment ◽  
Randomised Controlled

IntroductionEarly breast cancer detection and advancements in treatment options have resulted in an increase of breast cancer survivors. An increasing number of women are living with the long-term effects of breast cancer treatment, making the quality of survivorship an increasingly important goal. Breast cancer-related lymphoedema (BCRL) is one of the most underestimated complications of breast cancer treatment with a reported incidence of 20%. A microsurgical technique called lymphaticovenous anastomosis (LVA) might be a promising treatment modality for patients with BCRL. The main objective is to assess whether LVA is more effective than the current standard therapy (conservative treatment) in terms of improvement in quality of life and weather it is cost-effective.Methods and analysisA multicentre, randomised controlled trial, carried out in two academic and two community hospitals in the Netherlands. The study population includes 120 women over the age of 18 who have undergone treatment for breast cancer including axillary treatment (sentinel lymph node biopsy or axillary lymph node dissection) and/or axillary radiotherapy, presenting with an early stage lymphoedema of the arm, viable lymphatic vessels and received at least 3 months conservative treatment. Sixty participants will undergo the LVA operation and the other sixty will continue their regular conservative treatment, both with a follow-up of 24 months. The primary outcome is the health-related quality of life. Secondary outcomes are societal costs, quality adjusted life years, cost-effectiveness ratio, discontinuation rate of conservative treatment and excess limb volume.Ethics and disseminationThe study was approved by the Ethics Committee of Maastricht University Medical Center (METC) on 19 December 2018 (NL67059.068.18). The results of this study will be disseminated in presentations at academic conferences, publications in peer-reviewed journals and other news media.Trial registration numberNCT02790021; Pre-results.

scholarly journals Task-oriented exercises improve disability of working patients with surgically-treated proximal humeral fractures. A randomized controlled trial with one-year follow-up

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Marco Monticone ◽  
Igor Portoghese ◽  
Daniele Cazzaniga ◽  
Valentina Liquori ◽  
Giuseppe Marongiu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Rehabilitation Program ◽  
Group Differences ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
One Year ◽  
Task Oriented

Abstract Background General physiotherapy is a common means of rehabilitation after surgery for proximal humeral fracture (PHF). Better-targeted exercises seem worthy of investigation and the aim of this study was to assess the efficacy of a rehabilitation program including task-oriented exercises in improving disability, pain, and quality of life in patients after a PHF. Methods By means of a randomized controlled trial with one-year follow-up, 70 working patients (mean age of 49 ± 11 years; 41 females), who were selected for open reduction and internal fixation with plates caused by PHF, were randomized to be included in an experimental (n = 35) or control group (n = 35). There was a permuted-block randomization plan, and a list of program codes was previously created; subsequently, an automatic assignment system was used to conceal the allocation. The first group underwent a supervised rehabilitation program of task-oriented exercises based on patients’ specific job activities, and occupational therapy. The second group underwent general physiotherapy, including supervised mobility, strengthening and stretching exercises. Both groups individually followed programs of 60-min session three times per week for 12 weeks in the outpatient setting. The Disability Arm Shoulder Hand questionnaire (DASH; scores range from 0 to 100; primary outcome), a Pain intensity Numerical Rating Scale (scores range 0 to 10; secondary outcomes), and the Short-Form Health Survey (scores range from 0 to 100; secondary outcomes) assessed the interventions. Participants were evaluated before surgery, before and after rehabilitation (primary endpoint), and at the one-year follow-up (secondary endpoint). A linear mixed model analysis for repeated measures was carried out for each outcome measure (p < 0.05). Results Time, group and time by group showed significant effects for all outcome measures in favour of the experimental group. The DASH and the DASH work achieved clinically important between-group differences of 16.0 points (95% confidence interval [C.I.] 7.3 to 24.7) and 19.7 (95% C.I. 9.0 to 30.5) at follow-up, respectively. The NRS achieved a between-group difference of 2.9 (95% C.I. 1.0 to 3.9) at follow-up. As for SF-36, there were between-group differences ranging from 17.9 to 37.0 at follow-up. Conclusions A rehabilitation program based on task-oriented exercises was useful in improving disability, pain, and quality of life in working patients after PHFs. Improvements lasted for at least 12 months. Trial registration On 16/12/2019, the trial was retrospectively registered in the ISRCTN registry with the ID number 17996552.

scholarly journals Slowly resorbable biosynthetic mesh: 2-year results in VHWG grade 3 hernia repair

Hernia ◽  
2021 ◽  
Author(s):  
M. M. J. Van Rooijen ◽  
T. Tollens ◽  
L. N. Jørgensen ◽  
T. S. de Vries Reilingh ◽  
G. Piessen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Hernia Repair ◽  
Hernia Recurrence ◽  
Recurrence Rates ◽  
Elective Repair ◽  
Significant Difference ◽  
Grade 3

Abstract Introduction Information on the long-term performance of biosynthetic meshes is scarce. This study analyses the performance of biosynthetic mesh (Phasix™) over 24 months. Methods A prospective, international European multi-center trial is described. Adult patients with a Ventral Hernia Working Group (VHWG) grade 3 incisional hernia larger than 10 cm2, scheduled for elective repair, were included. Biosynthetic mesh was placed in sublay position. Short-term outcomes included 3-month surgical site occurrences (SSO), and long-term outcomes comprised hernia recurrence, reoperation, and quality of life assessments until 24 months. Results Eighty-four patients were treated with biosynthetic mesh. Twenty-two patients (26.2%) developed 34 SSOs, of which 32 occurred within 3 months (primary endpoint). Eight patients (11.0%) developed a hernia recurrence. In 13 patients (15.5%), 14 reoperations took place, of which 6 were performed for hernia recurrence (42.9%), 3 for mesh infection (21.4%), and in 7 of which the mesh was explanted (50%). Compared to baseline, quality of life outcomes showed no significant difference after 24 months. Despite theoretical resorption, 10.7% of patients reported presence of mesh sensation in daily life 24 months after surgery. Conclusion After 2 years of follow-up, hernia repair with biosynthetic mesh shows manageable SSO rates and favorable recurrence rates in VHWG grade 3 patients. No statistically significant improvement in quality of life or reduction of pain was observed. Few patients report lasting presence of mesh sensation. Results of biosynthetic mesh after longer periods of follow-up on recurrences and remodeling will provide further valuable information to make clear recommendations. Trial registration Registered on clinicaltrials.gov (NCT02720042), March 25, 2016.

scholarly journals Evaluation of a Brief Intervention for Promoting Mental Health among Employees in Social Enterprises: A Cluster Randomized Controlled Trial

2018 ◽  
Vol 15 (10) ◽  
pp. 2107 ◽  
Author(s):  
Benedicte Deforche ◽  
Jasmine Mommen ◽  
Anne Hublet ◽  
Winnie De Roover ◽  
Nele Huys ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
Health Promotion ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Social Enterprises ◽  
Randomized Controlled ◽  
Cluster Randomized

Evidence on the effectiveness of workplace mental health promotion for people with disabilities is limited. This study aimed to evaluate the effectiveness of a brief mental health promotion intervention in social enterprises. It had a non-blinded cluster randomized controlled trial design with follow-up one and four months after the intervention. In total 196 employees agreed to participate (86 intervention and 110 control). Empowerment was the main outcome; secondary outcomes were resilience, palliative behavior, determinants of four coping strategies of mental health, quality of life, and life satisfaction. A brief participant satisfaction survey was conducted after the intervention. No significant intervention effect on empowerment was found. However, at one month follow-up, significant favorable effects were found on perceived social support for coping strategies for mental health and on palliative behavior. At four months follow-up, favorable intervention effects were found on quality of life, but unfavorable effects were found on unjustified worrying. In addition, the intervention was well received by the employees. This brief intervention might be a promising first step to improve mental health in people with disabilities working in social enterprises. Nevertheless, additional monitoring by professionals and managers working in the organizations might be needed to maintain these effects.

Intensive versus minimalist follow-up in patients treated for endometrial cancer: A multicentric randomized controlled trial (The TOTEM study—NCT00916708).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 5506-5506
Author(s):  
Paolo Zola ◽  
Giovannino Ciccone ◽  
Elisa Piovano ◽  
Luca Fuso ◽  
Elena Peirano ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Overall Survival ◽  
Endometrial Cancer ◽  
Cancer Patients ◽  
Early Recognition ◽  
Controlled Trial ◽  
Physical And Mental Health ◽  
Randomized Controlled

5506 Background: Intensive follow-up in cancer patients, which absorbs a lot of health system resources and can be a source of increased stress for patients, are often proposed on the assumption that an early recognition of relapse will translate in better outcomes. In endometrial cancer few randomized controlled trials were conducted to assess the role of a reduced number of the scheduled visits and of different settings of the follow-up, but did not investigate the contribution of routine serum, cytological or imaging follow-up investigations in improving overall survival or quality of life. The TOTEM study was planned to compare an intensive (INT) vs minimalist (MIN) 5- year follow-up regimen in endometrial cancer patients in terms of overall survival (OS). Methods: Patients surgically treated for endometrial cancer, in complete clinical remission confirmed by imaging, FIGO stage I-IV, were stratified by center and in low (LoR) or high (HiR) risk of recurrence and then randomized to INT or MIN hospital-based follow-up regimens. The main study hypothesis was to demonstrate an improvement from 75% to 80% (expected hazard ratio, HR = 0.78) of the 5-year OS with the INT regimen. Secondary objectives were to compare relapse free survival (RFS), health-related quality of life (HRQL) assessed at baseline, at 6 and 12 months and then yearly (with the SF-12 Physical and Mental Health Summary Scale) and costs. Results: 1884 patients were randomized in 42 centers between 2008 and 2018, and 1847 patients were available for the final analysis (60% LoR). Compliance with the follow-up scheduled visits was 75.3%, similar between INT (74.7%) and MIN (75.9%) arms, whereas the mean number of recorded exams (laboratory or imaging) was markedly higher in the INT than in the MIN arms (9.7 vs 2.9, p < 0.0001). After a median follow-up of 66 months, the overall 5-year OS was 91.3%, 90.6% in the INT and 91.9% in the MIN arms, respectively (HR = 1.12, 95%CI 0.85-1.48, p = 0.429). Comparing the INT vs MIN arms, the 5-year OS were 94.1% and 96.8% (HR = 1.48, 0.92-2.37, p = 0.104) in the LoR and 85.3% and 84.7% (HR = 0.96, 0.68-1.36, p = 0.814) in the HiR group. No relevant differences emerged in RFS between INT and MIN regimens, (HR = 1.13, 0.87-1.48, p = 0.365). At the time of the relapse most women were asymptomatic (146/228, 64.0%), with a tendency of higher proportions in the INT than in the MIN arm, both in the LoR group (78.8% vs 61.1%, p = 0.070) and in the HiR one (64% vs 60%, p = 0.754). HRQL was available only for a subgroup of patients (50% at baseline) and did not differ between arms. Conclusions: Intensive follow-up in endometrial cancer treated patients showed a weak and uncertain advantage in detecting earlier asymptomatic relapses but did not improve OS, even in HiR patients, nor influenced HRQL. Frequent routine use of imaging and laboratory exams in these patients should be discouraged. Clinical trial information: NCT00916708.

The Nature stroke study; NASTRU - A randomised controlled trial of nature-based post-stroke fatigue rehabilitation

2019 ◽  
Author(s):  
Anna María Pálsdóttir ◽  
Kjerstin Stigmar ◽  
Bo Norrving ◽  
Patrik Grahn ◽  
Ingemar F Petersson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Standard Care ◽  
Controlled Trial ◽  
Perceived Value ◽  
Control Group ◽  
Post Stroke ◽  
Randomised Controlled

Abstract Fatigue is common after stroke and contributes to disability and impaired quality of life. Currently, there is insufficient evidence on the efficacy of any intervention for post-stroke fatigue. The aim of the study was to examine whether 10 weeks Nature-based rehabilitation (NRB) as add-on to standard care may improve post-stroke fatigue, perceived value of everyday occupations, function, activity and participation compared to standard care only (Clinical Trial.gov Identifier: NCT02435043, 2012/352, 05-06-2015). The study was carried out as a single blinded two-armed randomised controlled trial. Stroke survivors identified through routine 3-month follow-up visit (sub-acute) or medical records (chronic stroke > 1 year earlier) were randomised to Standard care + NBR or Standard care only. Blinded evaluations were conducted at follow-up 8 and 14 months after randomisation. The primary outcomes were post-stroke fatigue (Mental Fatigue Scale, total score) and perceived value of everyday occupations (Oval-pd) 8 months after randomisation. About a quarter of the screened patients were eligible; half accepted to participate and 101 were randomised, mean age 67 years, 60% female. The patients with sub-acute stroke were highly compliant with the intervention. Fatigue decreased to a value below the suggested cut-off for mental fatigue (<10.5) in the intervention group but not in the control group; no statistically significant differences were found though between the groups. Conclusion: NASTRU is the first randomised study on NBR for patients with post stroke fatigue. NBR was feasible and well tolerated. The study was underpowered due to difficulties in recruiting participants. No significant differences were detected between intervention and control group. A larger RCT is warranted. Keywords: clinical trial, enriched environment, everyday occupations, horticulture therapy, quality of life.

scholarly journals Evaluation of a positive psychotherapy group intervention for people with psychosis: pilot randomised controlled trial

2015 ◽  
Vol 25 (3) ◽  
pp. 235-246 ◽  
Author(s):  
Beate Schrank ◽  
Tamsin Brownell ◽  
Zivile Jakaite ◽  
Charley Larkin ◽  
Francesca Pesola ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Group Intervention ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Self Esteem ◽  
Positive Psychotherapy ◽  
Main Effect ◽  
Randomised Controlled

Aims.Third-wave psychological interventions have gained relevance in mental health service provision but their application to people with psychosis is in its infancy and interventions targeting wellbeing in psychosis are scarce. This study tested the feasibility and preliminary effectiveness of positive psychotherapy adapted for people with psychosis (WELLFOCUS PPT) to improve wellbeing.Methods.WELLFOCUS PPT was tested as an 11-week group intervention in a convenience sample of people with psychosis in a single centre randomised controlled trial (ISRCTN04199273) involving 94 people with psychosis. Patients were individually randomised in blocks to receive either WELLFOCUS PPT in addition to treatment as usual (TAU), or TAU only. Assessments took place before randomisation and after the therapy. The primary outcome was wellbeing (Warwick-Edinburgh Mental Well-Being Scale, WEMWBS). Secondary outcomes included symptoms (Brief Psychiatric Rating Scale), depression (Short Depression-Happiness Scale), self-esteem, empowerment, hope, sense of coherence, savouring beliefs and functioning, as well as two alternative measures of wellbeing (the Positive Psychotherapy Inventory and Quality of Life). Intention-to-treat analysis was performed. This involved calculating crude changes and paired-sample t-tests for all variables, as well as ANCOVA and Complier Average Causal Effect (CACE) Analysis to estimate the main effect of group on all outcomes.Results.The intervention and trial procedures proved feasible and well accepted. Crude changes between baseline and follow-up showed a significant improvement in the intervention group for wellbeing according to all three concepts assessed (i.e., WEMWBS, Positive Psychotherapy Inventory and Quality of Life), as well as for symptoms, depression, hope, self-esteem and sense of coherence. No significant changes were observed in the control group. ANCOVA showed no main effect on wellbeing according to the primary outcome scale (WEMWBS) but significant effects on symptoms (p = 0.006, ES = 0.42), depression (p = 0.03, ES = 0.38) and wellbeing according to the Positive Psychotherapy Inventory (p = 0.02, ES = 0.30). Secondary analysis adapting for therapy group further improved the results for symptom reduction (p = 0.004, ES = 0.43) and depression (p = 0.03, ES = 0.41) but did not lead to any more outcomes falling below the p = 0.05 significance level. CACE analysis showed a non-significant positive association between the intervention and WEMWBS scores at follow-up (b = 0.21, z = 0.9, p = 0.4).Conclusions.This study provides initial evidence on the feasibility of WELLFOCUS PPT in people with psychosis, positively affecting symptoms and depression. However, more work is needed to optimise its effectiveness. Future research might evaluate positive psychotherapy as a treatment for comorbid depression in psychosis, and consider alternative measurements of wellbeing.

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