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How to train practising gynaecologists in total laparoscopic hysterectomy: protocol for the stepped-wedge IMAGINE trial.

ABSTRACT: INTRODUCTION:Hysterectomy is the most common major gynaecological procedure in women and minimally invasive approaches should be used wherever possible; total laparoscopic hysterectomy (TLH) is one such surgical approach which allows removal of the uterus entirely laparoscopically. However, lack of surgical training opportunities is impeding its increased adoption. This study will formally test a surgical outreach training model to equip surgeons with the skills to provide TLH as an alternative to total abdominal hysterectomy (TAH). METHODS AND ANALYSIS:Stepped wedge implementation trial of a surgical training programme for practising obstetrician gynaecologist specialists in four hospitals. PRIMARY OUTCOMES:Change in the proportion of hysterectomies performed by TAH, measured between preintervention and postintervention; we aim to reduce TAH by at least 30% in 75% of the trainees. SECONDARY OUTCOMES:(1) Number of hospitals screened, eligible, agree to training and complete the training; (2) number of surgeons screened for eligibility, eligible, agree to training, who complete training and achieve proficiency; (3) proportion of trainees achieving proficiency in correct theatre setup, vascular exposure, mobilisation and surgery closure; change in proportion proficient over time; (4) adverse events (conversion from TLH to TAH, anaesthetic incident, intraoperative visceral injury, red cell transfusions, hospital stay >7 days, incidental finding of malignancy, unplanned readmission, admission to intensive care, return to theatre, postoperative pulmonary embolism or deep vein thrombosis, development of a fistula, vault haematoma, vaginal vault dehiscence or pelvic infection); (5) hospital length-of-stay; (6) cost-effectiveness and (7) trainee surgeon proficiency with TLH. ETHICS AND DISSEMINATION:The study has been approved by the Royal Brisbane and Women's Hospital Human Research Ethics Committee and has received site-specific approval from all participating hospitals. Results will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER:NCT03617354; Pre-results.

SUBMITTER: Obermair A

PROVIDER: S-EPMC6528001 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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How to train practising gynaecologists in total laparoscopic hysterectomy: protocol for the stepped-wedge IMAGINE trial.

Obermair Andreas A Armfield Nigel R NR Graves Nicholas N Gebski Val V Hanna George B GB Coleman Mark G MG Hughes Anne A Janda Monika M

BMJ open 20190509 5

<h4>Introduction</h4>Hysterectomy is the most common major gynaecological procedure in women and minimally invasive approaches should be used wherever possible; total laparoscopic hysterectomy (TLH) is one such surgical approach which allows removal of the uterus entirely laparoscopically. However, lack of surgical training opportunities is impeding its increased adoption. This study will formally test a surgical outreach training model to equip surgeons with the skills to provide TLH as an alte ...[more]

PMID: 31072858

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Project description:This study directly compares total intrafascial laparoscopic (TAIL) hysterectomy with vaginal (VH) and abdominal (AH) hysterectomy with regard to safety, operating time and time of convalescence. The study is a prospective cohort study (Canadian Task Force classification II-2), including data from patients of a single university-affiliated teaching institution, admitted between 1997 and 2008 for hysterectomy due to benign uterus pathology. Patient data were collected pre-, intra- and postoperatively and complications documented using a standardised data sheet of a Swiss obstetric and gynaecological study group (Arbeitsgemeinschaft Schweizerische Frauenkliniken, Amlikon/Switzerland). Classification of complications (major complications and minor complications) for all three operation techniques, evaluation of surgeons and comparison of operation times and days of hospitalisation were analysed. 3066 patients were included in this study. 993 patients underwent AH, 642 VH and 1,431 total intrafascial hysterectomy. No statistically significant difference for the operation times comparing the three groups can be demonstrated. The mean hospital stay in the TAIL hysterectomy, VH and AH groups is 5.8 +/- 2.4, 8.8 +/- 4.0 and 10.4 +/- 3.9 days, respectively. The postoperative minor complications including infection rates are low in the TAIL hysterectomy group (3.8%) when compared with either the AH group (15.3%) or the VH group (11.2%), respectively. The total of minor complications is statistically significant lower for TAIL hysterectomy as for AH (O.R. 4.52, CI 3.25-6.31) or VH (O.R. 3.16, CI 2.16-4.62). Major haemorrhage with consecutive reoperation is observed statistically significantly more frequent in the AH group when compared to the TAIL hysterectomy group, with an O.R. of 6.13 (CI 3.05-12.62). Overall, major intra- and postoperative complications occur significant more frequently in the AH group (8.6%) when compared to the VH group (3%) and the TAIL hysterectomy group (1.8%). The incidence of major complications applying the standardised TAIL hysterectomy technique is not related to the experience of the surgeons. We conclude that a standardised intrafascial technique of total laparoscopic (TAIL) hysterectomy using an anatomically developed special uterine device is associated with a very low incidence of minor and major intra- and postoperative complications. The direct comparison of complication rates with either vaginal or abdominal hysterectomy favours the total laparoscopic technique, and therefore, this technique can be recommended as a relatively atraumatic procedure. The operation times are comparable for all three techniques without any statistically significant differences. This technique for laparoscopic hysterectomy is shown to be equally safe when applied by experienced gynaecologic surgeons or by residents in training. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s10397-010-0569-0) contains supplementary material, which is available to authorized users.

Project description:BackgroundThe effectiveness of laparoscopic ventral mesh rectopexy (LVMR) in patients with defecatory disorders secondary to internal rectal prolapse is poorly evidenced. A UK-based multicenter randomized controlled trial was designed to determine the clinical efficacy of LVMR compared to controls at medium-term follow-up.MethodsThe randomized controlled trial was conducted from March 1, 2015 TO January 31, 2019. A stepped-wedge RCT design permitted observer-masked data comparisons between patients awaiting LVMR (controls) with those who had undergone surgery. Adult participants with radiologically confirmed IRP refractory to conservative treatment were randomized to three arms with different delays before surgery. Efficacy outcome data were collected at equally stepped time points (12, 24, 36, 48, 60, and 72 weeks). Clinical efficacy of LVMR compared to controls was defined as ≥ 1.0-point reduction in Patient Assessment of Constipation-Quality of Life and/or Symptoms (PAC-QOL and/or PAC-SYM) scores at 24 weeks. Secondary outcome measures included 14-day diary data, the Generalized Anxiety Disorder scale (GAD-7), the Patient Health Questionnaire-9 (PHQ-9), St Marks incontinence score, the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), the chronic constipation Behavioral Response to Illness Questionnaire (CC-BRQ), and the Brief Illness Perception Questionnaire (BIPQ).ResultsOf a calculated sample size of 114, only 28 patients (100% female) were randomized from 6 institutions (due mainly to national pause on mesh-related surgery). Nine were assigned to the T0 arm, 10 to T12, and 9 to T24. There were no substantial differences in baseline characteristics between the three arms. Compared to baseline, significant reduction (improvement) in PAC-QOL and PAC-SYM scores were observed at 24 weeks post-surgery (- 1.09 [95% CI - 1.76, - 0.41], p = 0.0019, and - 0.92 [- 1.52, - 0.32], p = 0.0029, respectively) in the 19 patients available for analysis (9 were excluded for dropout [n = 2] or missing primary outcome [n = 7]). There was a clinically significant long-term reduction in PAC-QOL scores (- 1.38 [- 2.94, 0.19], p = 0.0840 at 72 weeks). Statistically significant improvements in PAC-SYM scores persisted to 72 weeks (- 1.51 [- 2.87, - 0.16], p = 0.0289). Compared to baseline, no differences were found in secondary outcomes, except for significant improvements at 24 and 48 weeks on CC-BRQ avoidance behavior (- 14.3 [95% CI - 23.3, - 5.4], and - 0.92 [- 1.52, - 0.32], respectively), CC-BRQ safety behavior (- 13.7 [95% CI - 20.5, - 7.0], and - 13.0 [- 19.8, - 6.1], respectively), and BIPQ negative perceptions (- 16.3 [95% CI - 23.5, - 9.0], and - 10.5 [- 17.9, - 3.2], respectively).ConclusionsWith the caveat of under-powering due to poor recruitment, the study presents the first randomized trial evidence of short-term benefit of LVMR for internal rectal prolapse.Trial registrationISRCTN Registry (ISRCTN11747152).

Project description:BackgroundAdvanced surgical techniques, such as total laparoscopic hysterectomy, are often challenging to acquire beyond fellowship training programs for practicing obstetrician-gynecologists. A lack of formative data currently exist for continuing medical education programs, limiting our understanding of how improvement in surgical skills and training programs occur.ObjectiveThis study aimed to investigate how practicing obstetrician-gynecologists acting as trainees experience a program that aims to teach them total laparoscopic hysterectomy, and to assess whether their surgical skills improve according to data from formative assessment tools and qualitative data from open-ended survey questions and in-depth interviews.Study designWe report a process analysis of formative data collected during a pilot implementation trial of a surgical training program targeting practicing obstetrician-gynecologists. Eleven consultant obstetrician-gynecologists and 4 experienced surgical mentors participated in 4 hospitals in Queensland, Australia. Total laparoscopic hysterectomy was performed in 700 patients over the course of the study. A total laparoscopic hysterectomy surgical mentorship training program of 10 training days with up to 3 total laparoscopic hysterectomy procedures per day was performed. Both the obstetrician-gynecologists and the surgical mentor completed a formative assessment questionnaire analyzing the trainee's performance after each surgical procedure. Mentors were formatively assessed by the Structured Training Trainer Assessment Report (STTAR) and at the completion of the study by the mini-STTAR, a summative assessment of quality of mentorship. Obstetrician-gynecologists, mentors, hospital leaders, and surgical administrative staff participated in qualitative interviews about the training program.ResultsOver time, there was a demonstrated improvement in trainee performance reported by both mentors and trainees in all competency assessment tool domains as the case number increased, with mentors consistently rating trainees' performance higher than the trainees themselves. Most trainees were satisfied with their mentor in all 31 areas during formative assessment, and at the end of the training, structure, attributes, and role modeling were all rated high (average score >4.5; range, 3.79-5.00), whereas training behavior was rated slightly lower at 4.1 (range, 3.79-4.45). Qualitative interviews demonstrated that the trainees found the training to be a beneficial, hands-on experience.ConclusionFormative assessment clearly documented improvement in surgical skills during a total laparoscopic hysterectomy training program for consultant obstetrician-gynecologists.

Project description:IntroductionAn ageing population has become an urgent concern for Asia in recent times. In nursing homes, polypharmacy has also become a compounding issue. Deprescribing practice is an evidence-based strategy to provide a better outcome in this group of patients; however, its implementation in nursing homes is often challenging, and prospective outcome data on deprescribing practice in the elderly is lacking. Our study assesses the implementation of team-care deprescribing to understand the benefits of this practice in geriatric setting and to explore the factors affecting deprescribing practice.Methods and analysisThis multicentre prospective study consists of a prestudy interview questionnaire, and a preintervention and postintervention study to be conducted in the nursing home setting on residents at least 65 years old and on five or more medications. We will employ a cluster randomised stepped-wedge interventional design, based on a five-step (reviewing, checking, discussion, communication and documentation) team-care deprescribing practice coupled with the use of a deprescribing guide (consisting of Beers and STOPP criteria, as well as drug interaction checking), to assess the health and pharmacoeconomic outcome in nursing homes' practice. Primary outcome measures of the intervention will consist of fall risks using a fall risk assessment tool. Other outcomes assessed include fall rates, pill burden including number of pills per day, number of doses per day and number of medications prescribed. Cost-related measures will include the use of cost-benefit analysis, which is calculated from the medication cost savings from deprescribing. For the prestudy interview questionnaire, findings will be analysed qualitatively using thematic analysis.Ethics and disseminationThis study is approved by the Domain Specific Review Board of National Healthcare Group, Singapore (2016/00422) and Monash University Human Research Ethics Committee (2016-1430-7791). The study findings shall be disseminated in international conferences and peer-reviewed publications. The study is registered with ClinicalTrials.gov (NCT02863341), Pre-results.

Dataset Information

How to train practising gynaecologists in total laparoscopic hysterectomy: protocol for the stepped-wedge IMAGINE trial.

Publications

How to train practising gynaecologists in total laparoscopic hysterectomy: protocol for the stepped-wedge IMAGINE trial.

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