scholarly journals Pretreatment with transcutaneous electrical acupoint stimulation to prevent postoperative ileus in patients undergoing laparoscopic colon surgery: study protocol for a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e030694
Author(s):  
Jian Wang ◽  
Dongli Li ◽  
Wei Tang ◽  
Jun Guo ◽  
Wenting Chen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomised Controlled Trial ◽  
Postoperative Ileus ◽  
Controlled Trial ◽  
Colon Surgery ◽  
Laparoscopic Colon Surgery ◽  
Laparoscopic Colon ◽  
Randomised Controlled ◽  
Oral Diet ◽  
Acupoint Stimulation

IntroductionPostoperative ileus (POI), a common complication after surgery, severely affects postoperative recovery. It is unclear whether pretreatment with transcutaneous electrical acupoint stimulation (TEAS) can improve recovery from POI. This trial will evaluate the effects of pretreatment with TEAS on POI.Methods and analysisThis will be a prospective, randomised controlled trial. American Society of Anesthesiologists (ASA) physical status classification I–III level patients, aged 18–75 years and scheduled for laparoscopic colon surgery, will be included in the study. It is planned that 146 subjects will be randomised to the TEAS and sham TEAS (STEAS) groups. The groups will undergo two sessions of TEAS/STEAS daily for 3 days before surgery, with a final TEAS/STEAS treatment 30 min before anaesthesia. The primary endpoint of the study will be time to first defaecation. Secondary endpoints will include time to first flatus, time to tolerance of oral diet, GI-2 (composite outcome of time to first defaecation and time to tolerance of oral diet), time to independent walking, length of hospital stay, postoperative pain Visual Analogue Scale score on the first 3 days after surgery, analgesic requirements, complications and plasma concentrations of interferon-β (IFN-β), IFN-γ, interleukin-6 (IL-6) and IL-1β. Multiple linear regression will be used to identify independent predictors of outcome measures.Ethics and disseminationThis study has been approved by the Chinese Registered Clinical Trial Ethics Review Committee (No. ChiECRCT-20170084). The results of the trial will be published in an international peer-reviewed journal.Trial registration numberThis study has been registered with the Chinese Clinical Trial Registry (No. ChiCTR-INR-17013184).Trial statusThe study was in the recruitment phase at the time of manuscript submission.

Process and Resource Assessment in Trials Undertaken in Residential Care Homes: Experiences from the Australian MIDDEL Cluster Randomised Controlled Trial Research Team.

2020 ◽  
Author(s):  
Felicity Anne Baker ◽  
Phoebe Stretton-Smith ◽  
Tanara Vieira Sousa ◽  
Imogen Clark ◽  
Alice Cotton ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Resource Assessment ◽  
Trial Registration ◽  
Residential Aged Care ◽  
Cluster Randomised ◽  
Intervention Adherence ◽  
Randomised Controlled

Abstract Background: The resources involved in delivering a clinical trial in residential aged care facilities (RACFs) are significant and the success of a trial is dependent upon adequate planning, including appropriate timelines for each component of the study and the required budget. The main aim of this paper is to describe process and resource assessment during recruitment, collection of outcome measures and intervention delivery and present learnings and considerations for conducting trials in RACFs with people living with dementia. Methods: We collected data across 24 clusters in 12 RACFs over 18 months during a cluster randomised controlled trial which was testing the effectiveness of music interventions in people living with dementia. Data were collected on resources required for recruitment and assessment of baseline data, as well as data on reasons for participant non-attendance at the interventions. Results: Results show that time between contacting next of kin and receiving formal consent often exceeded 45 days and the ratio of time between direct and indirect research activity is approximately 1:2. Participant intervention adherence is at risk from unplanned RACF lockdowns and reasons for non-attendance include those both related directly to the participant and to staff resources, scheduling or other practical considerations. Conclusions: Researchers planning studies within RACFs should focus on building relationships with RACF staff and resident families, factor in adequate time for recruitment in the study timeline and consider budgeting for backfill of RACF staff during data collection phases to expedite the process and ensure adherence to study protocol timelines. This study provides specific data on resource assessment and intervention adherence that could be beneficial for future researchers planning to conduct trials in RACFs with people with dementia. Trial registration: Australian and New Zealand Clinical Trial Registry: ANZCTR12618000156280, 1/02/2018, http://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12618000156280

scholarly journals Effectiveness and safety of early intramuscular botulinum toxin injections to prevent shoulder deformity in babies with brachial plexus birth injury (POPB-TOX), a randomised controlled trial: study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e032901 ◽  
Author(s):  
Christelle Pons ◽  
Dauphou Eddi ◽  
Gregoire Le Gal ◽  
Marc Garetier ◽  
Douraied Ben Salem ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Botulinum Toxin ◽  
Randomised Controlled Trial ◽  
Humeral Head ◽  
Controlled Trial ◽  
Birth Injury ◽  
Posterior Subluxation ◽  
Randomised Controlled ◽  
Botulinum Toxin Injections ◽  
Brachial Plexus Birth Injury

IntroductionIn children with brachial plexus birth injury (BPBI), denervation of the shoulder muscles leads to bony deformity in the first months of life, reducing active and passive range of motion (ROM) and causing activity limitation. The aim of this multicentre randomised controlled trial is to evaluate the effectiveness of botulinum toxin injections (BTI) in the shoulder internal rotator muscles of 12-month-old babies in limiting the progression of posterior subluxation of the glenohumeral joint, compared with a sham procedure mimicking BTI. The secondary aims are to evaluate the effectiveness of BTI in (1) limiting the progression of glenoid retroversion and three-dimensional (3D) deformity and (2) improving shoulder ROM and upper limb function, as well as to confirm the tolerance of BTI.Methods and analysisSixty-two babies with unilateral BPBI and a risk of posterior humeral head subluxation will be included. Only those with at least 7% posterior subluxation of the humeral head compared with the contralateral shoulder on the MRI will be randomised to one of two groups: ‘BTI’ and ‘Sham’. The BTI group will receive BOTOX injections at the age of 12 months in the internal shoulder rotator muscles (8 UI/kg). The sham group will undergo a sham BTI procedure. Both groups will undergo repeated shoulder MRI at 18 months of age to quantify changes in the percentage of posterior migration of the humeral head (primary outcome), glenoid version and 3D bone deformity. Clinical evaluations (passive shoulder ROM, active movement scale) will be carried out at baseline and 15 and 18 months of age. The mini-assisting hand assessment will be rated between 10 and 11 months and at 18 months of age. Adverse events will be recorded at least monthly for each child.Ethics and disseminationFull ethical approval for this study has been obtained. The findings will be disseminated in peer-reviewed publications.Trial registration numberEudraCT: 2015-001402-34 in European Clinical Trial database;NCT03198702in Clinical Trial database; Pre-results.

scholarly journals Transcutaneous electrical acupoint stimulation combined with electroacupuncture for rapid recovery of patients after laparotomy for gastrointestinal surgery: a study protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e053309
Author(s):  
Hao Li ◽  
Qian Wen ◽  
Lingyun Lu ◽  
Hangqi Hu ◽  
Ying He ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Abdominal Surgery ◽  
Perioperative Management ◽  
Controlled Trial ◽  
Gastrointestinal Surgery ◽  
Rapid Recovery ◽  
Surgical Trauma ◽  
Solid Diet ◽  
Randomised Controlled ◽  
Acupoint Stimulation

IntroductionAbdominal surgery is associated with common complications, including decreased or poor appetite, abdominal distension, abdominal pain caused by decreased or absent gastrointestinal motility, anal arrest with flatus and defecation, and nausea and vomiting resulting from the use of anaesthetics and opioid analgesics. These complications seriously affect postoperative recovery, prolong hospital stay and aggravate patient burden. This study aims to investigate for the first time the efficacy of transcutaneous electrical acupoint stimulation (TEAS) combined with electroacupuncture (EA) therapy for rapid recovery after laparotomy for gastrointestinal surgery. There have been no clinical studies of this combination therapy.Methods and analysisThis will be a prospective, single-centre, three-arm, randomised controlled trial. A total of 480 patients undergoing abdominal surgery will be stratified according to surgery type (ie, gastric or colorectal procedure) and randomised into three groups; namely, the EA, TEAS +EA and control groups. The control group will receive enhanced recovery after surgery (ERAS)-standardised perioperative management, including preoperative education, optimising the anaesthesia scheme, avoiding intraoperative hypothermia, restrictive fluid infusion and reducing surgical trauma. The EA group will receive EA stimulation at LI4, PC6, ST36, ST37 and ST39 based on the ERAS-standardised perioperative management. Moreover, the TEAS +EA group will receive ERAS-standardised perioperative management; EA stimulation at the LI4, PC6, ST36, ST37 and ST39; and TEAS stimulation at ST21 and SP15. The primary outcome will be the GI-2 (composite outcome of time to first defaecation and time to tolerance of a solid diet). Secondary outcomes will include the time of first passage of flatus, time to first defaecation, time to tolerance of a solid diet, time to first ambulation, hospital duration from operation to discharge, pain and nausea vomiting scores on the Visual Analogue Scale, medication use, incidence of postoperative complications and evaluation of treatment modality acceptability. All statistical analyses will be performed based on the intention-to-treat principle.Ethics and disseminationEthics approval has been granted by the Ethics Committee on Biomedical Research, West China Hospital of Sichuan University (approval number: 2021; number 52). The results are expected to be published in peer-reviewed journals.Trial registration numberChiCTR2100045646.

scholarly journals The proximal hamstring avulsion clinical trial (PHACT)—a randomised controlled non-inferiority trial of operative versus non-operative treatment of proximal hamstrings avulsions: study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e031607 ◽  
Author(s):  
Elsa Pihl ◽  
Målfrid Holen Kristoffersen ◽  
Anne-Mari Rosenlund ◽  
Sofia Laszlo ◽  
Mida Berglöf ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomised Controlled Trial ◽  
Operative Treatment ◽  
Controlled Trial ◽  
Prospective Trial ◽  
Functional Score ◽  
Patient Reported ◽  
Randomised Controlled ◽  
Proximal Hamstring Avulsion ◽  
Proximal Hamstring

IntroductionThe treatment of proximal hamstring avulsions is controversial. While several trials have investigated the outcome for patients treated surgically, there is today no prospective trial comparing operative treatment with non-operative treatment. This protocol describes the design for the proximal hamstring avulsion clinical trial (PHACT)—the first randomised controlled trial of operative versus non-operative treatment for proximal hamstring avulsions.Methods and analysisPHACT is a multicentre randomised controlled trial conducted across Sweden, Norway and Finland. Eligible patients (60 participants/treatment arm) with a proximal hamstring avulsion of at least two of three tendons will be randomised to either operative or non-operative treatment. Participants allocated to surgery will undergo reinsertion of the tendons with suture anchors. The rehabilitation programme will be the same for both treatment groups. When patient or surgeon equipoise for treatment alternatives cannot be reached and randomisation therefore is not possible, patients will be invited to participate in a parallel observational non-randomised cohort. The primary outcome will be the patient-reported outcome measure Perth hamstring assessment tool at 24 months. Secondary outcomes include the Lower Extremity Functional Score, physical performance and muscle strength tests, patient satisfaction and MR imaging. Data analysis will be blinded and intention-to-treat analysis will be preformed.Ethics and disseminationEthical approval has been granted by the Ethical Committee of Uppsala University (DNR: 2017–170) and by the Norwegian ethical board (REC: 2017/1911). The study will be conducted in agreement with the Helsinki declaration. The findings will be disseminated in peer-reviewed publications.Trial registration numberNCT03311997

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