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Assessing the value of eHealth for bariatric surgery (BePatient trial): study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:The expansion of digital devices and widespread access to the Internet has opened up opportunities to provide patients with more personal information. It can be hypothesized that eHealth in addition to standard care could enhance clinical outcomes such as increased weight loss, co-morbidity reduction, and commitment to the program. The beneficial value of incorporating eHealth applications as standard postoperative care is yet to be established. In this trial, the value of different levels of eHealth are assessed. METHODS/DESIGN:Two hundred adult patients with a body mass index (BMI) ??40 kg/m2, or ??35 kg/m2 with obesity-related co-morbidity, undergoing sleeve gastrectomy or gastric bypass will be enrolled in this randomized controlled trial. Patients will be randomly assigned to one of the groups: receiving standard care (control group, n =?100); have access to an online eHealth platform in addition to the previous group (online group, n =?50); or receive wireless monitoring devices in addition to previous groups (device group, n =?50). The total follow-up period is two years postoperatively. Primary outcome is weight loss in terms of BMI. Secondary outcomes include: quality of life; return-to-work time; co-morbidity reduction; additional contacts; and ease of use of devices. DISCUSSION:In this trial, the value of different levels of eHealth will be assessed. This addresses an important aspect of a changing healthcare environment. TRIAL REGISTRATION:Trialregister.nl, NTR6827. Retrospectively registered on 19 November 2017. http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6827 .

SUBMITTER: Versteegden DPA

PROVIDER: S-EPMC6237032 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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Assessing the value of eHealth for bariatric surgery (BePatient trial): study protocol for a randomized controlled trial.

Versteegden Dirk P A DPA Van Himbeeck Magaly J J MJJ Nienhuijs Simon W SW

Trials 20181114 1

<h4>Background</h4>The expansion of digital devices and widespread access to the Internet has opened up opportunities to provide patients with more personal information. It can be hypothesized that eHealth in addition to standard care could enhance clinical outcomes such as increased weight loss, co-morbidity reduction, and commitment to the program. The beneficial value of incorporating eHealth applications as standard postoperative care is yet to be established. In this trial, the value of dif ...[more]

PMID: 30428902

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Project description:BackgroundObesity represents a major public health problem and is the fifth leading risk factor for mortality. Morbid obesity is associated with chronic systemic inflammation which increases the risk of comorbidities. Bariatric surgery (BS) is considered an effective intervention for obese patients. However, BS is associated with dietary restriction, potentially limiting physical activity. Whole-body neuromuscular electrical stimulation (WBS) could represent an innovative option for the rehabilitation of BS patients, especially during the early postoperative phase when other conventional techniques are contraindicated. WBS is a safe and effective tool to combat sarcopenia and metabolic risk as well as increasing muscle mass, producing greater glucose uptake, and reducing the proinflammatory state. Therefore, the objective of this study is to evaluate the effects of WBS on body composition, functional capacity, muscle strength and endurance, insulin resistance, and pro- and anti-inflammatory circulating markers in obese patients undergoing BS.Methods/designThe present study is a randomized, double-blind, placebo-controlled, parallel groups clinical trial approved by the Ethics Committee of our Institution. Thirty-six volunteers (body mass index (BMI)?>?35 kg/m2) between 18 and 45 years of age will be randomized to the WBS group (WBSG) or control (Sham) group (ShamG) after being submitted to BS. Preoperative assessments will include maximal and submaximal exercise testing, body composition, blood inflammatory markers, and quadriceps strength and endurance. The second day after discharge, body composition will be evaluated and a 6-min walk test (6MWT) will be performed. The WBS or Sham protocol will consist of 30 daily sessions for 6 consecutive weeks. Afterwards, the same assessments that were performed in the preoperative period will be repeated.DiscussionConsidering the important role of WBS in skeletal muscle conditioning and its value as an aid in exercise performance, the proposed study will investigate this technique as a tool to promote early rehabilitation in these patients, and as a strategy to enhance exercise capacity, weight loss, and peripheral muscle strength with positive systemic effects. The present study is still ongoing, and data will be published after its conclusion.Trial registrationREBEC, RBR-99qw5h . Registered on 20 February 2015.

Project description:BackgroundVision is an important and defining element of laparoscopy and significantly affects the outcome of surgery in terms of time, error, and precision. Several new imaging systems have become available for laparoscopic surgery, including three-dimensional (3D) high-definition (HD) and two-dimensional (2D) ultra-high-resolution (4K) monitors. 3D HD systems offer a number of potential benefits to surgeons and patients over traditional 2D systems, including reduced operating time, blood loss, and hospital stay. However, the performance of 3D systems against the new, ultra-high definition 4K systems is barely known and highly controversial. There is a paucity of studies comparing them in clinical settings. The aim of this study is to compare 2D 4K and 3D HD perspectives in gastric bypass surgery.MethodsForty-eight patients with an indication for gastric bypass will be randomized to receive laparoscopic gastric bypass surgery using either 2D 4K or 3D HD systems. The operations will be performed by a well-coordinated team of three senior surgeons. The primary outcome is operative time. Secondary outcomes include intraoperative complications, blood loss, operator workload as assessed by the validated Surg-TLX questionnaire, and postoperative complications according to the Clavien-Dindo classification. An interim analysis is planned after enrollment of 12 participants for each group.DiscussionThis prospective, randomized trial is designed to test the hypothesis that the use of a 3D HD system will result in a significant improvement in operative time compared to a 2D 4K system in bariatric surgery. The objective is to provide clinical evidence for new laparoscopic imaging systems and to evaluate potential benefits.Trial registrationThis trial is registered at clinicaltrials.gov under the identifier NCT05895058. Registered 30 May 2023. BASEC2023-D0014 [Registry ID Swissethics, approved 3 May 2023]. SNCTP000005489 [SNCTP study register, last updated 13 July 2023].

Project description:Background:Severe weight loss through means of bariatric surgery has been associated with loss of muscle mass due to lack of absorption of protein. The aim of this RCT is to investigate the effectiveness of protein supplementation in reducing the risk of developing protein malnutrition and muscle wasting in post-bariatric surgery patients in Qatar. Methods and analysis:The study was based at the Department of bariatric and metabolic surgery, Doha metropolitan and regional areas. It is envisaged that approximately 160 post-bariatric surgery patients will be randomized and followed up for 6 months. These will be males and females obese (BMI >35) Qatari patients between the aged 18-60 years. Subjects with renal or liver disease and those with past history of bariatric surgery will be excluded. By the completion of the trial, patients who took less than 80% of the supplement will be further excluded from the final analysis. Protein supplement (Cubitan,Protein, Nutricia, Netherlands) that contain daily intake of 20 g of protein to be taken orally 3 times a day throughout the study period. The placebo group will receive identical ampule containing zero-protein with exact instructions as per the intervention group. Body weight, muscle and fat mass, total protein, albumin, vit B12, Magnesium and Zinc will be measured at baseline and every follow up/study visit. Study variables will be compared between the 2 groups at different stages of the trial, including baseline, using Sample T-test (paired and unpaired) and the significance level will be confirmed with the 95% confidence interval with alpha error set to 0.05. Ethics and dissemination:Protein supplementation for post-bariatric patients is not yet a standard procedure at Hamad Medical Corporation in Qatar and requires an RCT to establish evidence-based clinical practice guidelines. This study was approved by the Hamad Medical Corporation IRB and MRC committees (approval no. 16433/16). Trial registration:ClinicalTrials.gov NCT03147456 (registration date: 18 April 2017). Strengths and limitations of this study:One major strength of our study is that our population is a distinctive population (Qatari Obese patients) where results from international studies may not apply to the local and unique context. A local study like ours will provide healthcare providers in Qatar an opportunity to ensure good clinical practice and healthy and sustainable weight loss following bariatric surgery.The well-designed double-blinded RCT will almost certainly provide us with the evidence-based clinical practice guideline that we seek as health professionals.One limitation of our study is the slight discrepancy in caloric content of the intervention and the placebo (250 cal and 100 cal, respectively). However, it is the intervention that has the higher caloric content, in which case it may not influence the results in the direction of our hypothesis that protein supplementation leads to lower fat mass and higher muscle mass.Another limitation is that the use of the intervention and the placebo are not objectively measured. However, all efforts will be made to ensure compliance and reporting of consumption of products.A third limitation could be loss to follow up. Participants may cease to participate, particularly, once they have lost "sufficient' weight and gained the fitness to consume any type of foods they desire. This is common in late stages of post-bariatric surgery (beyond 3 months). We feel that this may be a challenge, particularly in reference to our specific population. However, such findings albeit negative, should serve in improving the clinical practice delivered by healthcare providers.

Project description:BACKGROUND:Up to a third of stroke patients and patients with traumatic brain injury suffer from insomnia, including problems to fall asleep or stay asleep at night. Insomnia may exacerbate other brain damage-related problems, for example regarding cognitive functioning and emotional well-being; may lead to poorer quality of life; and may complicate recovery processes. Cognitive behavioral therapy for insomnia, delivered face-to-face or online, is found to be effective in the general population. However, despite the high prevalence and serious consequences of insomnia following acquired brain injury, studies on the efficacy of face-to-face cognitive behavioral treatment in this population are scarce, and this applies even more for studies on online cognitive behavioral therapy. Therefore, this study aims to evaluate the efficacy of a newly developed guided online cognitive behavioral therapy for insomnia following acquired brain injury. METHODS:A multicenter, prospective, randomized, open-label, blinded end point study (PROBE) will be conducted, in which 48 patients diagnosed with stroke or traumatic brain injury and insomnia will be randomly allocated to the online cognitive behavioral therapy for insomnia treatment group or the treatment as usual group. The treatment consists of 6 online cognitive behavioral therapy sessions given on a weekly basis and personalized feedback after each session, combined with 2 face-to-face sessions. Outcomes will be assessed at baseline, immediately after the intervention period and at 6-week follow-up. The primary outcome is the insomnia severity assessed with the Insomnia Severity Index. Secondary outcome measures include sleep quality, sleep features derived from the sleep diary, fatigue, anxiety and depression, subjective cognitive functioning, and societal participation. DISCUSSION:This study will provide insight on the efficacy of online cognitive behavioral therapy for insomnia following stroke and traumatic brain injury. TRIAL REGISTRATION:Netherlands Trial Register NTR7082 . Registered on 12 March 2018.

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Assessing the value of eHealth for bariatric surgery (BePatient trial): study protocol for a randomized controlled trial.

Publications

Assessing the value of eHealth for bariatric surgery (BePatient trial): study protocol for a randomized controlled trial.

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