scholarly journals Techniques and timings for cleft palate surgery: a randomised controlled trial

2019 ◽  
Vol 2 (1) ◽  
pp. 44-54 ◽  
Author(s):  
Vincent Yeow ◽  
Selena Ee-Li Young ◽  
Philip Kuo-Ting Chen ◽  
Seng Tiek Lee ◽  
David Machin ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Otitis Media ◽  
Controlled Trial ◽  
Surgical Techniques ◽  
Complication Rates ◽  
Randomised Trials ◽  
Secondary Palate ◽  
Postsurgical Complication ◽  
Randomised Controlled ◽  
Cleft Surgery

Background: There is a lack of reliable information on outcomes following cleft surgery. Options for timing and choice of primary cleft surgery had not been compared in randomised trials. Methods: Non-syndromic infants, aged six months, with isolated cleft of the secondary palate without associated lip deformity, were included in this prospective randomised controlled trial to one of four options: Veau-Wardill-Kilner palatoplasty at six (VWK06) or 12 months of age (VWK12), or two-flap palatoplasty with intra-velar veloplasty at six (2F-IVV06) or 12 months of age (2F-IVV12).  Results: Of the 76 infants included in the trial, 90.8 per cent received surgery: VWK06 (n=18), VWK12 (n=16), 2F-IVV06 (n=18) and 2F-IVV12 (n=17). Early postoperative complications occurred in two VWK infants (6.1%) and three 2F-IVV infants (8.8%). With surgery planned at six (T06) and 12 months of age (T12) respectively, there were three VWK infants (8.6%) and two 2F-IVV infants (6.3%). At age three, speech assessments were conducted for 62 (84%) children. Velopharyngeal inadequacy symptoms were detected in 4/30 VWK children (13.3%) and 3/30 2F-IVV children (10.0%). With T06 and T12, there were three VWK infants (9.4%) and four 2F-IVV infants (14.3%). Otitis media was documented in 40/61 of children (65.6%) hyper- and/or hyponasality in 27/61 of children (44%) and articulation errors in 53/60 of children (88%). Conclusion: Postsurgical complication rates differ little between VWK and 2F-IVV. At three years, there were no demonstrable differences in velopharyngeal inadequacy symptoms, nasality, articulation and otitis media between the two surgical techniques at two different times.

scholarly journals Long-term outcomes of two-stage, immediate and delayed breast reconstruction with polyurethane-covered versus textured implants: protocol of a prospective, multicentre randomised controlled trial (TIPI trial)

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e044219
Author(s):  
J X Harmeling ◽  
Kevin Peter Cinca ◽  
Eleni-Rosalina Andrinopoulou ◽  
Eveline M L Corten ◽  
M A Mureau
Keyword(s):  
Randomised Controlled Trial ◽  
Breast Reconstruction ◽  
Controlled Trial ◽  
Capsular Contracture ◽  
Tissue Expander ◽  
Complication Rates ◽  
Two Stage ◽  
Randomised Controlled

IntroductionTwo-stage implant-based breast reconstruction is the most commonly performed postmastectomy reconstructive technique. During the first stage, a tissue expander creates a sufficiently large pocket for the definite breast implant placed in the second stage. Capsular contracture is a common long-term complication associated with implant-based breast reconstruction, causing functional complaints and often requiring reoperation. The exact aetiology is still unknown, but a relationship between the outer surface of the implant and the probability of developing capsular contracture has been suggested. The purpose of this study is to determine whether polyurethane-covered implants result in a different capsular contracture rate than textured implants.Methods and analysisThe Textured Implants versus Polyurethane-covered Implants (TIPI) trial is a multicentre randomised controlled trial with a 1:1 allocation rate and a follow-up of 10 years. A total of 321 breasts of female adults undergoing a two-stage breast reconstruction will be enrolled. The primary outcome is capsular contracture at 10-year follow-up which is graded with the modified Baker classification. It is analysed with survival analysis using a frailty model for clustered interval-censored data, with both an intention-to-treat and per-protocol approach. Secondary outcomes are other complication rates, surgical revision rate, patient satisfaction and quality of life and user-friendliness. Outcomes are measured 2 weeks, 6 months, 1, 2, 3, 5 and 10 years postoperatively. Interim analysis is performed when 1-year, 3-year and 5-year follow-up is completed.Ethics and disseminationThe trial has been reviewed and approved by the Medical Research Ethics Committee of the Erasmus MC, University Medical Centre Rotterdam (MEC-2018-126) and locally by each participating centre. Written informed consent will be obtained from each study participant. The results will be disseminated by publication in peer-reviewed journals.Trial registrationNTR7265.

scholarly journals Pylorus resection versus pylorus preservation in pancreatoduodenectomy (PyloResPes): study protocol and statistical analysis plan for a German multicentre, single-blind, surgical, registry-based randomised controlled trial

2021 ◽  
Author(s):  
Bernhard W Renz ◽  
Christine Adrion ◽  
Carsten Klinger ◽  
Matthias Ilmer ◽  
Jan D'Haese ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Large Scale ◽  
Controlled Trial ◽  
Pancreatic Head ◽  
Operation Time ◽  
Perioperative Outcomes ◽  
Complication Rates ◽  
Pylorus Preservation ◽  
Randomised Controlled ◽  
Pylorus Resection

Introduction Partial pancreatoduodenectomy (PD) is the treatment of choice for various benign and malignant tumours of the pancreatic head or the periampullary region. For reconstruction of the gastrointestinal passage, two stomach preserving PD variants exist: pylorus preservation (ppPD), or pylorus resection (prPD) with preservation of the stomach. In pancreatic surgery, delayed gastric emptying (DGE) remains a serious complication after PD with an incidence varying between 4.5% and 45%, potentially delaying hospital discharge or further treatment, e.g. adjuvant chemotherapy. Evidence is lacking to assess which variant of PD entails fewer postoperative DGE. Methods and analysis The protocol of a large-scale, multicentre, pragmatic, two-arm parallel-group, registry-based randomised controlled trial (rRCT) using a two-stage group-sequential design is presented. This patient-blind rRCT aims to demonstrate the superiority of prPD over ppPD with respect to the overall incidence of DGE within 30 days after index surgery in a German real-world setting. A total of 984 adults undergoing elective PD for any indication will be randomised in a 1:1 ratio. Patients will be recruited at about 30 hospitals being members of the StuDoQ|Pancreas registry established by the German Society of General and Visceral Surgery (DGAV). The postoperative follow-up for each patient will be 30 days. The primary analysis will follow an intention-to-treat approach and applies a binary logistic random intercepts model. Secondary perioperative outcomes include overall severe morbidity (Clavien-Dindo classification), blood loss, 30-day all-cause mortality, postoperative hospital stay, and operation time. Complication rates and adverse events will be closely monitored. Ethics and dissemination This protocol was approved by the leading ethics committee of the Medical Faculty of the Ludwig-Maximilians-University, Munich (reference no. 19-221). The results will be published in a peer-reviewed journal and presented at international conferences. Study findings will also be disseminated via the website (http://www.dgav.de/studoq/pylorespres/). Trial registration number DRKS-ID: DRKS00018842 (https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00018842, prospectively registered on 24-Oct-2019)

scholarly journals Feasibility of a multicentre, randomised controlled trial of laparoscopic versus open colorectal surgery in the acute setting: the LaCeS feasibility trial protocol

BMJ Open ◽  
2018 ◽  
Vol 8 (2) ◽  
pp. e018618 ◽  
Author(s):  
Deena Harji ◽  
Helen Marshall ◽  
Katie Gordon ◽  
Hannah Crow ◽  
Victoria Hiley ◽  
...  
Keyword(s):  
Laparoscopic Surgery ◽  
Randomised Controlled Trial ◽  
Colorectal Surgery ◽  
Controlled Trial ◽  
Phase Iii ◽  
Feasibility Trial ◽  
Complication Rates ◽  
Acute Setting ◽  
Patient Reported ◽  
Randomised Controlled

IntroductionAcute colorectal surgery forms a significant proportion of emergency admissions within the National Health Service. There is limited evidence to suggest minimally invasive surgery may be associated with improved clinical outcomes in this cohort of patients. Consequently, there is a need to assess the clinical effectiveness and cost-effectiveness of laparoscopic surgery in the acute colorectal setting. However,emergency colorectal surgical trials have previously been difficult to conduct due to issues surrounding recruitment and equipoise. The LaCeS (randomised controlled trial of Laparoscopic versus open Colorectal Surgery in the acute setting) feasibility trial will determine the feasibility of conducting a definitive, phase III trial of laparoscopic versus open acute colorectal resection.Methods and analysisThe LaCeS feasibility trial is a prospective, multicentre, single-blinded, parallel group, pragmatic randomised controlled feasibility trial. Patients will be randomised on a 1:1 basis to receive eitherlaparoscopic or open surgery. The trial aims to recruit at least 66 patients from five acute general surgical units across the UK. Patients over the age of 18 with a diagnosis of acute colorectal pathology requiring resection on clinical and radiological/endoscopic investigations, with a National Confidential Enquiry into Patient Outcome and Death classification of urgent will be considered eligible for participation. The primary outcome is recruitment. Secondary outcomes include assessing the safety profile of laparoscopic surgery using intraoperative and postoperative complication rates, conversion rates and patient-safety indicators as surrogate markers. Clinical and patient-reported outcomes will also be reported. The trial will contain an embedded qualitative study to assess clinician and patient acceptability of trial processes.Ethics and disseminationThe LaCeS feasibility trial is approved by the Yorkshire and The Humber, Bradford Leeds Research Ethics Committee (REC reference: 15/ YH/0542). The results from the trial will be presented at national and international colorectal conferences and will be submitted for publication to peer-reviewed journals.Trial registration numberISRCTN15681041; Pre-results.

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