scholarly journals Long-term patient satisfaction and durability of laparoscopic anti-reflux surgery in a large Danish cohort: study protocol for a retrospective cohort study with development of a novel scoring system for patient selection

BMJ Open ◽  
2020 ◽  
Vol 10 (3) ◽  
pp. e034257
Author(s):  
Jonas Sanberg Ljungdalh ◽  
Katrine Hass Rubin ◽  
Jesper Durup ◽  
Kim Christian Houlind

IntroductionLaparoscopic anti-reflux surgery is standard of care in surgical treatment of gastro-oesophageal reflux disease and is not without risks of adverse effects, including disruption of the fundoplication and postfundoplication dysphagia, in some cases leading to reoperation. Non-surgical factors such as pre-existing anxiety or depression influence postoperative satisfaction and symptom relief. Previous studies have focused on a short-term follow-up or only certain aspects of disease, such as reoperation or postoperative quality of life. The aim of this study is to evaluate long-term patient-satisfaction and durability of laparoscopic anti-reflux surgery in a large Danish cohort using a comprehensive multimodal follow-up, and to develop a clinically applicable scoring system usable in selecting patients for anti-reflux surgery.Methods and analysisThe study is a retrospective cohort study utilising data from patient records and follow-up with patient-reported quality of life as well as registry-based data. The study population consists of all adult patients having undergone laparoscopic anti-reflux surgery at The Department of Surgery, Kolding Hospital, a part of Lillebaelt Hospital Denmark in an 11-year period. From electronic records; patient characteristics, preoperative endoscopic findings, reflux disease characteristics and details on type of surgery, will be identified. Disease-specific quality of life and dysphagia will be collected from a patient-reported follow-up. From Danish national registries, data on comorbidity, reoperative surgery, use of pharmacological anti-reflux treatment, mortality and socioeconomic factors will be included. Primary outcome of this study is treatment success at follow-up.Ethics and disseminationStudy approval has been obtained from The Danish Patient Safety Agency, The Danish Health Data Authority and Statistics Denmark, complying to Danish and EU legislation. Inclusion in the study will require informed consent from participating subjects. The results of the study will be published in peer-reviewed medical journals regardless of whether these are positive, negative or inconclusive.Trial registration numberClinicaltrials.gov (NCT03959020).

2021 ◽  
Author(s):  
Louise Sigfrid ◽  
Tom M Drake ◽  
Ellen Pauley ◽  
Edwin C Jesudason ◽  
Piero Olliaro ◽  
...  

Structured Abstract Objectives: The long-term consequences of severe Covid-19 requiring hospital admission are not well characterised. The objective of this study was to establish the long-term effects of Covid-19 following hospitalisation and the impact these may have on patient reported outcome measures. Design: A multicentre, prospective cohort study with at least 3 months follow-up of participants admitted to hospital between 5th February 2020 and 5th October 2020. Setting: 31 hospitals in the United Kingdom. Participants: 327 hospitalised participants discharged alive from hospital with confirmed/high likelihood SARS-CoV-2 infection. Main outcome measures and comparisons: The primary outcome was self-reported recovery at least ninety days after initial Covid-19 symptom onset. Secondary outcomes included new symptoms, new or increased disability (Washington group short scale), breathlessness (MRC Dyspnoea scale) and quality of life (EQ5D-5L). We compared these outcome measures across age, comorbidity status and in-hospital Covid-19 severity to identify groups at highest risk of developing long-term difficulties. Multilevel logistic and linear regression models were built to adjust for the effects of patient and centre level risk factors on these outcomes. Results: In total 53.7% (443/824) contacted participants responded, yielding 73.8% (327/443) responses with follow-up of 90 days or more from symptom onset. The median time between symptom onset of initial illness and completing the participant questionnaire was 222 days (Interquartile range (IQR) 189 to 269 days). In total, 54.7% (179/327) of participants reported they did not feel fully recovered. Persistent symptoms were reported by 93.3% (305/325) of participants, with fatigue the most common (82.8%, 255/308), followed by breathlessness (53.5%, 175/327). 46.8% (153/327) reported an increase in MRC dyspnoea scale of at least one grade. New or worse disability was reported by 24.2% (79/327) of participants. Overall (EQ5D-5L) summary index was significantly worse at the time of follow-up (median difference 0.1 points on a scale of 0 to 1, IQR: -0.2 to 0.0). Females under the age of 50 years were five times less likely to report feeling recovered (adjusted OR 5.09, 95% CI 1.64 to 15.74), were more likely to have greater disability (adjusted OR 4.22, 95% CI 1.12 to 15.94), twice as likely to report worse fatigue (adjusted OR 2.06, 95% CI 0.81 to 3.31) and seven times more likely to become more breathless (adjusted OR 7.15, 95% CI 2.24 to 22.83) than men of the same age. Conclusions: Survivors of Covid-19 experienced long-term symptoms, new disability, increased breathlessness, and reduced quality of life. These findings were present even in young, previously healthy working age adults, and were most common in younger females. Policymakers should fund further research to identify effective treatments for long-Covid and ensure healthcare, social care and welfare support is available for individuals with long-Covid.  


2019 ◽  
Vol 32 (12) ◽  
pp. 754 ◽  
Author(s):  
Pedro Videira Reis ◽  
Catarina Rocha Vieira ◽  
Ana Cristina Midões ◽  
Virginia Rebelo ◽  
Paula Barbosa ◽  
...  

Introduction: Spasticity is a complex problem in patients with neurological disorders and may distress their quality of life. Intrathecal baclofen infusion pumps reduce spasticity with low doses and minimal side effects but are not free from complications. We aimed to evaluate the efficacy and safety of intrathecal baclofen infusion pumps as well as patients’ satisfaction.Material and Methods: Retrospective cohort study including all intrathecal baclofen infusion pumps placed up to December 2015. Demographic characteristics, clinical diagnoses, date of placement or withdrawal/replacement of intrathecal baclofen infusion pumps, baclofen dosage and complications of intrathecal baclofen infusion pumps were collected. Assessments from the Ashworth and Penn’s scales, Katz index and patients’ global satisfaction were analysed.Results: In 19 years we placed 251 intrathecal baclofen infusion pumps in 155 patients. The mean age was 41.1 ± 15.8 years. The most frequent conditions were: trauma (34%), cerebral palsy (14%), multiple sclerosis (12%) and stroke (12%). Eighty-five patients (55%) required a second pump, and eleven (7%) a third one. The lifetime of the first pump was 72 (36 – 89) and the total follow-up time was 96 (9 – 132) months. The causes of withdrawal/replacement were: battery failure (57%), catheter migration/kinking (24%), infection (14%) and pump displacement/exteriorization (7%). The complication rate was 0.21 events/month. There was a significant improvement in the Ashworth and Penn’s scales after the placemen of intrathecal baclofen infusion pumps (p < 0.001 for all diagnoses) and the patients were satisfied with the treatment.Discussion: The incidence of complications was within range of other international studies despite our long follow-up time. Events per month, loss to follow-up, re-intervention rate, incidence of infection and mortality were similar to other studies.Conclusion: Intrathecal baclofen infusion pumps are safe and effective in the treatment of spasticity. Infusion pumps provide a high level of satisfaction regarding treatment and quality of life.


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