Endoscopic sutured gastroplasty in addition to lifestyle modification: short-term efficacy in a controlled randomised trial

Gut ◽  
2020 ◽  
pp. gutjnl-2020-322026
Author(s):  
Vincent Huberty ◽  
Ivo Boskoski ◽  
Vincenzo Bove ◽  
Pauline Van Ouytsel ◽  
Guido Costamagna ◽  
...  
Keyword(s):  
Weight Loss ◽  
Lifestyle Modification ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Body Weight Loss ◽  
Total Body Weight ◽  
Control Group ◽  
Short Term ◽  
Randomised Controlled

ObjectiveEndoscopic suture gastroplasty (ESG) has been developed as an alternative treatment for moderately obese patients. We present our results of a short-term randomised controlled trial on a new suturing technique, the Endomina system (E-ESG, Endo Tools therapeutics, Belgium).DesignEligible patients (body mass index 30–40 kg/m2) were randomised in a 2:1 ratio to receive lifestyle modification plus E-ESG or lifestyle modification alone (control group); dietetic counselling and follow-up were identical. Endpoints included a mean excess weight loss (EWL) of more than 25% 12 months after E-ESG and a 15% EWL difference at 6 months between groups. At 6 months, a cross-over to E-ESG was offered to the control group. All patients were followed for a total of 12 months after E-ESG.ResultsOf the 71 patients included (five male, mean age 40 years), mean EWL at 6 months was significantly higher in the treatment (38.6%, n=45) than in the control group (13.4%, n=21; p<0.001). At 6 months, satiety tests demonstrated a higher decrease in mean volume (41% vs 2.5%, p<0.001), and mean quality of life (QoL) was also higher in the treatment group (52.8 vs 45.1 p<0.05). No procedure-related or device-related severe adverse events were observed. Twelve months follow-up after E-ESG showed a mean EWL of 45.1%, which translated into a total body weight loss of 11.8%.ConclusionsThis study demonstrates that E-ESG is safe and effective, providing a 25% better EWL at 6 months than lifestyle modification alone. This weight loss was maintained and resulted in a significant improvement in QoL up to 18 months after treatment.Trial registration numberNCT03255005.

scholarly journals Redo endoscopic sleeve gastroplasty: technical aspects and short-term outcomes

2020 ◽  
Vol 13 ◽  
pp. 175628481989617 ◽  
Author(s):  
Ivo Boškoski ◽  
Valerio Pontecorvi ◽  
Camilla Gallo ◽  
Vincenzo Bove ◽  
Lucrezia Laterza ◽  
...  
Keyword(s):  
Weight Loss ◽  
Case Series ◽  
Body Weight Loss ◽  
Total Body Weight ◽  
Baseline Body Mass Index ◽  
Short Term ◽  
Technical Aspects ◽  
Endoscopic Sleeve Gastroplasty ◽  
Sleeve Gastroplasty

Background: Endoscopic sleeve gastroplasty (ESG) is a restrictive endoscopic bariatric procedure providing promising results. In this short case series, we analyze the technical aspects and short-term outcomes of the redo ESG. Methods: A retrospective analysis was done on a prospective database of all patients that were selected by a multidisciplinary team that underwent ESG between March 2017 and May 2019. Patients that underwent a redo ESG because of a progressive loss of satiety, weight regain, or insufficient weight loss due to high baseline body mass index were included. Percentage of excess weight loss (%EWL), percentage of total body weight loss (%TBWL), and the Bariatric Analysis and Reporting Outcome System (BAROS) questionnaire were evaluated during follow-up. Results: A total of 120 ESG procedures were performed with mean %EWL of 44.4% (± 19.5), mean %TBWL of 18.3% (± 6.7), and mean BAROS of 4.5 (± 1.7) at 12 months. Of those, four patients that underwent a redo ESG were identified. A total of three of them had a redo ESG after 12 months from the first ESG, whereas one of them had a redo ESG after 7 months. During the second procedure, old threads were removed with scissors and new stitches were positioned following a triangular pattern and avoiding overlap with the previous stitches. No adverse events were reported during the redo ESG. Six month follow-up was available for three patients, mean %EWL and %TBWL were 44.2% and 20.4%, respectively; BAROS questionnaire mean score was 6.3. One patient had only 1 month follow-up with a mean %EWL and %TBWL of 33.3% and 12.2%, respectively; BAROS questionnaire reported score was 6. All included patients reported excellent satiety feeling after redo ESG. Conclusions: The redo ESG short-term outcomes are completely satisfying in terms of safety and efficacy. The need to perform a redo ESG should not be considered as a failure of the previous procedure, but it can be considered as a second step of the endoscopic treatment strategy.

A Comparison of Acupuncture with Advice and Exercises on the Symptomatic Treatment of Osteoarthritis of the Hip – a Randomised Controlled Trial

2001 ◽  
Vol 19 (1) ◽  
pp. 19-26 ◽  
Author(s):  
Roisin Haslam
Keyword(s):  
Controlled Trial ◽  
Randomised Trial ◽  
Symptomatic Treatment ◽  
Post Treatment ◽  
Control Group ◽  
Group A ◽  
Pre Treatment ◽  
Group B ◽  
Randomised Controlled

Acupuncture is becoming a common technique within the physiotherapy profession as a treatment modality for pain relief; however, few randomised controlled trials have been undertaken to assess the effectiveness of acupuncture, particularly in the treatment of osteoarthritis (OA) of the hip. Therefore, a randomised trial to compare the effectiveness of acupuncture with advice and exercises on the symptomatic treatment of OA of the hip was carried out. Thirty-two patients awaiting a total hip arthroplasty were randomly allocated to either the experimental group, (A), to have six sessions of acupuncture each lasting up to 25 minutes, or the control group, (B), to be given advice and exercises for their hip over a six week period. Group A consisted of three men and 13 women, and group B consisted of four men and eight women. The average age in group A was 66 years and in group B it was 68 years. Patients were assessed for pain and functional ability, using a modified version of the WOMAC questionnaire, pre-treatment, immediately post-treatment and at eight weeks post-treatment. The pre-treatment WOMAC scores in the two groups were similar (p=0.85). There was a significant improvement in group A (decrease in WOMAC score) immediately post-treatment (p=0.002) and this was maintained at the eight-week follow-up (p=0.03). There were no significant changes in group B. When the changes in WOMAC scores were compared between groups, a significantly greater improvement was found between pre-treatment and immediately post-treatment in group A, compared with group B (p=0.02). The changes between pre-treatment and the eight-week follow-up also showed a significant improvement in group A compared with group B (p=0.03). In conclusion, this trial supports the hypothesis that acupuncture is more effective than advice and exercises in the symptomatic treatment of OA of the hip.

scholarly journals Anti-adhesion Gel versus No gel following Operative Hysteroscopy prior to Subsequent fertility Treatment or timed InterCourse (AGNOHSTIC), a randomised controlled trial: protocol

2021 ◽  
Vol 2021 (1) ◽  
Author(s):  
S van Wessel ◽  
T Hamerlynck ◽  
V Schutyser ◽  
C Tomassetti ◽  
C Wyns ◽  
...  
Keyword(s):  
Live Birth ◽  
Financial Support ◽  
Controlled Trial ◽  
Reproductive Age ◽  
Fertility Treatment ◽  
Control Group ◽  
Women Of Reproductive Age ◽  
Operative Hysteroscopy ◽  
Randomised Controlled

Abstract STUDY QUESTIONS Does the application of anti-adhesion gel, compared to no gel, following operative hysteroscopy to treat intrauterine pathology in women wishing to conceive increase the chance of conception leading to live birth? WHAT IS KNOWN ALREADY Intrauterine adhesions (IUAs) following operative hysteroscopy may impair reproductive success in women of reproductive age. Anti-adhesion barrier gels may decrease the occurrence of IUAs, but the evidence on their effectiveness to improve reproductive outcomes is sparse and of low quality. STUDY DESIGN, SIZE, DURATION This multicentre, parallel group, superiority, blinded and pragmatic randomised controlled trial is being carried out in seven participating centres in Belgium. Recruitment started in April 2019. Women will be randomly allocated to treatment with anti-adhesion gel (intervention group) or no gel (control group). Sterile ultrasound gel will be applied into the vagina as a mock-procedure in both treatment arms. The patient, fertility physician and gynaecologist performing the second-look hysteroscopy are unaware of the allocated treatment. Power analysis, based on a target improvement of 15% in conception leading to live birth using anti-adhesion gel, a power of 85%, a significance level of 5%, and a drop-out rate of 10%, yielded a number of 444 patients to be randomised. The baseline rate of conception leading to live birth in the control group is expected to be 45%. PARTICIPANTS/MATERIALS, SETTING, METHODS Women of reproductive age (18–47 years), wishing to conceive (spontaneously or by fertility treatment) and scheduled for operative hysteroscopy to treat intrauterine pathology (endometrial polyps, myomas with uterine cavity deformation, uterine septa, IUAs or retained products of conception) are eligible for recruitment. Women may try to conceive from 3 to 6 weeks after receiving allocated treatment with follow-up ending at 30 weeks after treatment. If the woman fails to conceive within this timeframe, a second-look hysteroscopy will be scheduled within 2–6 weeks to check for IUAs. The primary endpoint is conception leading to live birth, measured at 30 weeks after randomisation. The secondary endpoints are time to conception, clinical pregnancy, miscarriage and ectopic pregnancy rates, measured at 30 weeks after receiving allocated treatment. The long-term follow-up starts when the patient is pregnant and she will be contacted every trimester. STUDY FUNDING/COMPETING INTEREST(S) This work is funded by the Belgian Healthcare Knowledge Centre (KCE). The anti-adhesion gel is supplied at no cost by Nordic Pharma and without conditions. Dr. Tomassetti reports grants and non-financial support from Merck SA, non-financial support from Ferring SA, personal fees and non-financial support from Gedeon-Richter, outside the submitted work. None of the other authors have a conflict of interest.

scholarly journals Nurse-based secondary preventive follow-up by telephone reduced recurrence of cardiovascular events: a randomised controlled trial

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Anna-Lotta Irewall ◽  
Anders Ulvenstam ◽  
Anna Graipe ◽  
Joachim Ögren ◽  
Thomas Mooe
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Endpoint ◽  
Cardiovascular Events ◽  
Controlled Trial ◽  
Control Group ◽  
Coronary Syndrome ◽  
Secondary Endpoints ◽  
Randomised Controlled

AbstractEnhanced follow-up is needed to improve the results of secondary preventive care in patients with established cardiovascular disease. We examined the effect of long-term, nurse-based, secondary preventive follow-up by telephone on the recurrence of cardiovascular events. Open, randomised, controlled trial with two parallel groups. Between 1 January 2010 and 31 December 2014, consecutive patients (n = 1890) admitted to hospital due to stroke, transient ischaemic attack (TIA), or acute coronary syndrome (ACS) were included. Participants were randomised (1:1) to nurse-based telephone follow-up (intervention, n = 944) or usual care (control, n = 946) and followed until 31 December 2017. The primary endpoint was a composite of stroke, myocardial infarction, cardiac revascularisation, and cardiovascular death. The individual components of the primary endpoint, TIA, and all-cause mortality were analysed as secondary endpoints. The assessment of outcome events was blinded to study group assignment. After a mean follow-up of 4.5 years, 22.7% (n = 214) of patients in the intervention group and 27.1% (n = 256) in the control group reached the primary composite endpoint (HR 0.81, 95% CI 0.68–0.97; ARR 4.4%, 95% CI 0.5–8.3). Secondary endpoints did not differ significantly between groups. Nurse-based secondary preventive follow-up by telephone reduced the recurrence of cardiovascular events during long-term follow-up.

scholarly journals A Short Mindfulness Retreat for Students to Reduce Stress and Promote Self-Compassion: Pilot Randomised Controlled Trial Exploring Both an Indoor and a Natural Outdoor Retreat Setting

Healthcare ◽  
2021 ◽  
Vol 9 (7) ◽  
pp. 910
Author(s):  
Dorthe Djernis ◽  
Mia S. O’Toole ◽  
Lone O. Fjorback ◽  
Helle Svenningsen ◽  
Mimi Y. Mehlsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Effect Sizes ◽  
Medium Effect ◽  
Control Group ◽  
Post Intervention ◽  
Pilot Randomised Controlled Trial ◽  
Self Compassion ◽  
Randomised Controlled

Here, we developed and examined a new way of disseminating mindfulness in nature to people without meditation experience, based on the finding that mindfulness conducted in natural settings may have added benefits. We evaluated a 5-day residential programme aiming to reduce stress and improve mental health outcomes. We compared an indoor and an outdoor version of the programme to a control group in a pilot randomised controlled trial (RCT). Sixty Danish university students experiencing moderate to high levels of stress were randomised into a residential mindfulness programme indoors (n = 20), in nature (n = 22), or a control group (n = 18). Participants completed the Perceived Stress Scale and the Self-Compassion Scale (primary outcomes) along with additional secondary outcome measures at the start and end of the program and 3 months after. Stress was decreased with small to medium effect sizes post-intervention, although not statistically significant. Self-compassion increased post-intervention, but effect sizes were small and not significant. At follow-up, changes in stress were not significant, however self-compassion increased for both interventions with medium-sized effects. For the intervention groups, medium- to large-sized positive effects on trait mindfulness after a behavioural task were found post-intervention, and small- to medium-sized effects in self-reported mindfulness were seen at follow-up. Connectedness to Nature was the only outcome measure with an incremental effect in nature, exceeding the control with a medium-sized effect at follow-up. All participants in the nature arm completed the intervention, and so did 97% of the participants in all three arms. Overall, the results encourage the conduct of a larger-scale RCT, but only after adjusting some elements of the programme to better fit and take advantage of the potential benefits of the natural environment.

scholarly journals Functional electrical stimulation‐assisted cycle ergometry-based progressive mobility programme for mechanically ventilated patients: randomised controlled trial with 6 months follow-up

Thorax ◽  
2021 ◽  
pp. thoraxjnl-2020-215755
Author(s):  
Petr Waldauf ◽  
Natália Hrušková ◽  
Barbora Blahutova ◽  
Jan Gojda ◽  
Tomáš Urban ◽  
...  
Keyword(s):  
Electrical Stimulation ◽  
Randomised Controlled Trial ◽  
Functional Electrical Stimulation ◽  
Controlled Trial ◽  
Cycle Ergometry ◽  
Control Group ◽  
Mechanically Ventilated ◽  
Icu Discharge ◽  
Randomised Controlled

PurposeFunctional electrical stimulation-assisted cycle ergometry (FESCE) enables in-bed leg exercise independently of patients’ volition. We hypothesised that early use of FESCE-based progressive mobility programme improves physical function in survivors of critical care after 6 months.MethodsWe enrolled mechanically ventilated adults estimated to need >7 days of intensive care unit (ICU) stay into an assessor-blinded single centre randomised controlled trial to receive either FESCE-based protocolised or standard rehabilitation that continued up to day 28 or ICU discharge.ResultsWe randomised in 1:1 ratio 150 patients (age 61±15 years, Acute Physiology and Chronic Health Evaluation II 21±7) at a median of 21 (IQR 19–43) hours after admission to ICU. Mean rehabilitation duration of rehabilitation delivered to intervention versus control group was 82 (IQR 66–97) versus 53 (IQR 50–57) min per treatment day, p<0.001. At 6 months 42 (56%) and 46 (61%) patients in interventional and control groups, respectively, were alive and available to follow-up (81.5% of prespecified sample size). Their Physical Component Summary of SF-36 (primary outcome) was not different at 6 months (50 (IQR 21–69) vs 49 (IQR 26–77); p=0.26). At ICU discharge, there were no differences in the ICU length of stay, functional performance, rectus femoris cross-sectional diameter or muscle power despite the daily nitrogen balance was being 0.6 (95% CI 0.2 to 1.0; p=0.004) gN/m2 less negative in the intervention group.ConclusionEarly delivery of FESCE-based protocolised rehabilitation to ICU patients does not improve physical functioning at 6 months in survivors.Trial registration numberNCT02864745.

Capsular closure versus unrepaired interportal capsulotomy after hip arthroscopy in patients with femoroacetabular impingement, results of a patient-blinded randomised controlled trial

2021 ◽  
pp. 112070002110057
Author(s):  
Niels H Bech ◽  
Inger N Sierevelt ◽  
Sheryl de Waard ◽  
Boudijn S H Joling ◽  
Gino M M J Kerkhoffs ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Femoroacetabular Impingement ◽  
Hip Arthroscopy ◽  
Controlled Trial ◽  
Poor Quality ◽  
Control Group ◽  
Treatment Groups ◽  
Significant Difference ◽  
Randomised Controlled

Background: Hip capsular management after hip arthroscopy remains a topic of debate. Most available current literature is of poor quality and are retrospective or cohort studies. As of today, no clear consensus exists on capsular management after hip arthroscopy. Purpose: To evaluate the effect of routine capsular closure versus unrepaired capsulotomy after interportal capsulotomy measured with NRS pain and the Copenhagen Hip and Groin Outcome Score (HAGOS). Materials and methods: All eligible patients with femoroacetabular impingement who opt for hip arthroscopy ( n = 116) were randomly assigned to one of both treatment groups and were operated by a single surgeon. Postoperative pain was measured with the NRS score weekly the first 12 weeks after surgery. The HAGOS questionnaire was measured at 12 and 52 weeks postoperatively. Results: Baseline characteristics and operation details were comparable between treatment groups. Regarding the NRS pain no significant difference was found between groups at any point the first 12 weeks after surgery ( p = 0.67). Both groups significantly improved after surgery ( p < 0.001). After 3 months follow-up there were no differences between groups for the HAGOS questionnaire except for the domain sport ( p = 0.02) in favour of the control group. After 12 months follow-up there were no differences between both treatment groups on all HAGOS domains ( p  > 0.05). Conclusions: The results of this randomised controlled trial show highest possible evidence that there is no reason for routinely capsular closure after interportal capsulotomy at the end of hip arthroscopy. Trial Registration: This trial was registered at the CCMO Dutch Trial Register: NL55669.048.15.

scholarly journals Optimising medication management in children and young people with ADHD using a computerised test (QbTest): a feasibility randomised controlled trial

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Laura Williams ◽  
Charlotte L. Hall ◽  
Sue Brown ◽  
Boliang Guo ◽  
Marilyn James ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Young People ◽  
Controlled Trial ◽  
Medication Management ◽  
Control Group ◽  
Global Functioning ◽  
Children And Young People ◽  
Link Type ◽  
Randomised Controlled

Abstract Background Medication for attention deficit hyperactivity disorder (ADHD) should be closely monitored to ensure optimisation. There is growing interest in using computerised assessments of ADHD symptoms to support medication monitoring. The aim of this study was to assess the feasibility and acceptability of a randomised controlled trial (RCT) to evaluate the efficacy of one such computerised assessment, the Quantified Behavior (Qb) Test, as part of medication management for ADHD. Methods This feasibility multi-site RCT conducted in child and adolescent mental health and community paediatric settings recruited participants aged 6–15 years diagnosed with ADHD starting stimulant medication. Participants were randomised into one of two arms: experimental (QbTest protocol) where participants completed a QbTest at baseline and two follow-up QbTests on medication (2–4 weeks and 8–10 weeks later) and control where participants received treatment as usual, including at least two follow-up consultations. Measures of parent, teacher, and clinician-rated symptoms and global functioning were completed at each time point. Clinicians recorded treatment decision-making and health economic measures were obtained. Data were analysed using multi-level modelling and participants (children and parents) and clinicians were interviewed about their experiences, resulting data were thematically analysed. Results Forty-four children and young people were randomised. Completion of study outcome measures by care-givers and teachers ranged from 52 to 78% at baseline to 47–65% at follow-up. Participants reported the questionnaires to be useful to complete. SNAP-IV inattention scores showed greater reduction in the intervention than the control group (− 5.85, 95% CI − 10.33, − 1.36,). Engagement with the intervention ranged from 100% at baseline, to 78% follow-up 1 and 57% follow-up 2. However, only 37% of QbTests were conducted in the correct time period. Interview data highlighted that the objectivity of the QbTest was appreciated by clinicians and parents. Clinicians commented that the additional time and resources required meant that it is not feasible to use QbTest for all cases. Conclusion The trial design and protocol appear to be feasible and acceptable but could be improved by modifying QbTest time periods and the method of data collection. With these changes, the protocol may be appropriate for a full trial. Adding QbTest may improve symptom outcome as measured by SNAP-IV. Trial registration ClinicalTrials.gov, NCT03368573, prospectively registered, 11th December 2017, and ISRCTN, ISRCTN69461593, retrospectively registered, 10th April 2018

A Randomised Controlled Trial of Strategies to Prompt Attendance for a Pap Smear

1995 ◽  
Vol 2 (4) ◽  
pp. 211-218 ◽  
Author(s):  
Jenny Bowman ◽  
Rob Sanson-Fisher ◽  
Catherine Boyle ◽  
Stephanie Pope ◽  
Sally Redman
Keyword(s):  
At Risk ◽  
Randomised Controlled Trial ◽  
Pap Smear ◽  
Controlled Trial ◽  
Self Report ◽  
Health Clinic ◽  
Control Group ◽  
Screening Attendance ◽  
Randomised Controlled

Objective – To assess the comparative efficacy, by randomised controlled trial, of three interventions designed to encourage “at risk” women to have a Pap smear: an educational pamphlet; letters inviting attendance at a women's health clinic; and letters from physicians. Methods – Subjects at risk for cervical cancer who had not been adequately screened were identified by a random community survey and randomly allocated to one of the intervention groups or a control group. Six months after intervention implementation, a follow up survey assessed subsequent screening attendance. Self report was validated by comparison with a national screening data base. Results – A significantly greater proportion of women (36.9%) within the group receiving a physician letter reported screening at follow up than in any other group (P =0.012). The variables most strongly predicting screening attendance were: age, perceived frequency of screening required, use of oral contraceptives, and allocation to receive the physician letter intervention. Conclusions – The relative efficacy of the GP letter in prompting screening attendance shows that this strategy is worthy of further investigation. There remains a need to examine the barriers to screening for older women, and to develop tailored strategies for this population.

scholarly journals Milk supplementation facilitates appetite control in obese women during weight loss: a randomised, single-blind, placebo-controlled trial

2010 ◽  
Vol 105 (1) ◽  
pp. 133-143 ◽  
Author(s):  
Jo-Anne Gilbert ◽  
Denis R. Joanisse ◽  
Jean-Philippe Chaput ◽  
Pierre Miegueu ◽  
Katherine Cianflone ◽  
...  
Keyword(s):  
Weight Loss ◽  
Controlled Trial ◽  
Plasma Concentrations ◽  
Body Weight Loss ◽  
Obese Women ◽  
Appetite Control ◽  
Anthropometric Parameters ◽  
Ghrelin Concentration ◽  
Randomised Controlled ◽  
Desire To Eat

Dairy products provide Ca and protein which may facilitate appetite control. Conversely, weight loss is known to increase the motivation to eat. This randomised controlled trial verified the influence of milk supplementation on appetite markers during weight loss. Low Ca consumer women participated in a 6-month energy-restricted programme ( − 2508 kJ/d or − 600 kcal/d) and received either a milk supplementation (1000 mg Ca/d) or an isoenergetic placebo (n 13 and 12, respectively). Fasting appetite sensations were assessed by visual analogue scales. Anthropometric parameters and fasting plasma concentrations of glucose, insulin, leptin, ghrelin and cortisol were measured as well. Both groups showed a significant weight loss (P < 0·0001). In the milk-supplemented group, a time × treatment interaction effect showed that weight loss with milk supplementation induced a smaller increase in desire to eat and hunger (P < 0·05). Unlike the placebo group, the milk-supplemented group showed a lower than predicted decrease in fullness ( − 17·1 v. − 8·8; − 12·7 v. 3·3 mm, P < 0·05, measured v. predicted values, respectively). Even after adjustment for fat mass loss, changes in ghrelin concentration predicted those in desire to eat (r 0·56, P < 0·01), hunger (r 0·45, P < 0·05) and fullness (r − 0·40, P < 0·05). However, the study did not show a between-group difference in the change in ghrelin concentration in response to the intervention. These results show that milk supplementation attenuates the orexigenic effect of body weight loss. Trial registration code: ClinicalTrials.gov NTC00729170.

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