Feasibility of Prospectively Comparing Opioid Analgesia With Opioid-Free Analgesia After Outpatient General Surgery: A Pilot Randomized Clinical Trial.

Importance: The overprescription of opioids to surgical patients is recognized as an important factor contributing to the opioid crisis. However, the value of prescribing opioid analgesia (OA) vs opioid-free analgesia (OFA) after postoperative discharge remains uncertain. Objective: To investigate the feasibility of conducting a full-scale randomized clinical trial (RCT) to assess the comparative effectiveness of OA vs OFA after outpatient general surgery. Design, Setting, and Participants: This parallel, 2-group, assessor-blind, pragmatic pilot RCT was conducted from January 29 to September 3, 2020 (last follow-up on October 2, 2020). at 2 university-affiliated hospitals in Montreal, Quebec, Canada. Participants were adult patients (aged ≥18 years) undergoing outpatient abdominal (ie, cholecystectomy, appendectomy, or hernia repair) or breast (ie, partial or total mastectomy) general surgical procedures. Exclusion criteria were contraindications to drugs used in the trial, preoperative opioid use, conditions that could affect assessment of outcomes, and intraoperative or early complications requiring hospitalization. Interventions: Patients were randomized 1:1 to receive OA (around-the-clock nonopioids and opioids for breakthrough pain) or OFA (around-the-clock nonopioids with increasing doses and/or addition of nonopioid medications for breakthrough pain) after postoperative discharge. Main Outcomes and Measures: Main outcomes were a priori RCT feasibility criteria (ie, rates of surgeon agreement, patient eligibility, patient consent, treatment adherence, loss to follow-up, and missing follow-up data). Secondary outcomes included pain intensity and interference, analgesic intake, 30-day unplanned health care use, and adverse events. Between-group comparison of outcomes followed the intention-to-treat principle. Results: A total of 15 surgeons were approached; all (100%; 95% CI, 78%-100%) agreed to have patients recruited and adhered to the study procedures. Rates of patient eligibility and consent were 73% (95% CI, 66%-78%) and 57% (95% CI, 49%-65%), respectively. Seventy-six patients were randomized (39 [51%] to OA and 37 [49%] to OFA) and included in the intention-to-treat analysis (mean [SD] age, 55.5 [14.5] years; 50 [66%] female); 40 (53%) underwent abdominal surgery, and 36 (47%) underwent breast surgery. Seventy-five patients (99%; 95% CI, 93%-100%) adhered to the allocated treatment; 1 patient randomly assigned to OFA received an opioid prescription. Seventeen patients (44%) randomly assigned to OA consumed opioids after discharge. Seventy-three patients (96%; 95% CI, 89%-99%) completed the 30-day follow-up. The rate of missing questionnaires was 37 of 3724 (1%; 95% CI, 0.7%-1.4%). All the a priori RCT feasibility criteria were fulfilled. Conclusions and Relevance: The findings of this pilot RCT support the feasibility of conducting a robust, full-scale RCT to inform evidence-based prescribing of analgesia after outpatient general surgery. Trial Registration: ClinicalTrials.gov Identifier: NCT04254679.

Establishing validity evidence for device-assisted advanced laparoscopic suturing tasks using simulation.

BACKGROUND: Laparoscopic suturing (LS) is an essential technique required for a wide range of procedures, and it is one of the most challenging for surgical trainees to master. We designed and collected validity evidence for advanced LS tasks using an automated suturing device and evaluated the perceived educational value of the tasks. METHODS: This project was a multicentre prospective study involving McGill University, University of Toronto (UofT), and Louisiana State University (LSU) Health New Orleans. Novice (NS) and experienced (ES) surgeons performed suturing under tension (UT) and continuous suturing (CS) tasks. ES performed the tasks twice to establish proficiency benchmarks, and they were interviewed to develop formative feedback tools (FFT). Participants were assessed on completion time, error, Global Operative Assessment of Laparoscopic Skills (GOALS), and FFT. Data were analyzed using descriptive and inferential statistical methods. RESULTS: Twenty-seven participants (13 ES, 14 NS, median age 34 years; 85% male) completed the study. Eight were attending surgeons, 7 fellows, 4 PGY5, 5 PGY4, and 3 PGY3 (18 from McGill, 5 UofT, and 4 LSU). Comparing ES and NS, for UT task, ES had significantly greater task scores (570 [563-648] vs 323 [130-464], p value 0.00036) and GOALS scores (14 [13-16] vs 10 [8-12], p value 0.0038). Similarly, for CS, ES had significantly greater task scores (976 [959-1010] vs 785 [626-856], p value 0.00009) and GOALS scores (16 [12-17] vs 12.5 [8.25-15], p value 0.028). After FFTs were developed, comparing ES and NS, for both UT and CS tasks, ES had significantly greater FFT scores (UT 25 [24-26] vs 17 [14-20], p value 0.0016 and CS 30 [27-32] vs 22[17.2-25.8], p value 0.00061). CONCLUSION: In conclusion, preliminary validity evidence was provided for the tasks. Once further validity evidence is established, incorporating the tasks into the training curricula could improve trainee skills and help to meet the need for better advanced suturing models.

A scoping review of assessment tools for laparoscopic suturing.

BACKGROUND: A needs assessment identified a gap in teaching and assessment of laparoscopic suturing (LS) skills. The purpose of this review is to identify assessment tools that were used to assess LS skills, to evaluate validity evidence available, and to provide guidance for selecting the right assessment tool for specific assessment conditions. METHODS: Bibliographic databases were searched till April 2017. Full-text articles were included if they reported on assessment tools used in the operating room/simulation to (1) assess procedures that require LS or (2) specifically assess LS skills. RESULTS: Forty-two tools were identified, of which 26 were used for assessing LS skills specifically and 26 for procedures that require LS. Tools had the most evidence in internal structure and relationship to other variables, and least in consequences. CONCLUSION: Through identification and evaluation of assessment tools, the results of this review could be used as a guideline when implementing assessment tools into training programs.

Development of a Model for the Acquisition and Assessment of Advanced Laparoscopic Suturing Skills Using an Automated Device.

BACKGROUND: Needs assessment identified a gap regarding laparoscopic suturing skills targeted in simulation. This study collected validity evidence for an advanced laparoscopic suturing task using an Endo StitchTM device. METHODS: Experienced (ES) and novice surgeons (NS) performed continuous suturing after watching an instructional video. Scores were based on time and accuracy, and Global Operative Assessment of Laparoscopic Surgery. Data are shown as medians [25th-75th percentiles] (ES vs NS). Interrater reliability was calculated using intraclass correlation coefficients (confidence interval). RESULTS: Seventeen participants were enrolled. Experienced surgeons had significantly greater task (980 [964-999] vs 666 [391-711], P = .0035) and Global Operative Assessment of Laparoscopic Surgery scores (25 [24-25] vs 14 [12-17], P = .0029). Interrater reliability for time and accuracy were 1.0 and 0.9 (0.74-0.96), respectively. All experienced surgeons agreed that the task was relevant to practice. CONCLUSION: This study provides validity evidence for the task as a measure of laparoscopic suturing skill using an automated suturing device. It could help trainees acquire the skills they need to better prepare for clinical learning.

Epidural analgesia for traumatic rib fractures is associated with worse outcomes: a matched analysis.

BACKGROUND: The optimal method of pain control for patients with traumatic rib fractures is unknown. The aim of this study was to determine the effect of epidural analgesia on respiratory complications and in-hospital mortality in patients with rib fractures. METHODS: Adult patients at a level I trauma center with ≥1 rib fracture from blunt trauma were included (2004-2013). Those with a blunt-penetrating mechanism, traumatic brain injury, or underwent a laparotomy or thoracotomy were excluded. Patients who were treated with epidural analgesia (EPI) were compared with those were not treated with epidural analgesia (NEPI) using coarsened exact matching. Primary outcomes were respiratory complications (pneumonia, deep vein thrombosis/pulmonary embolus, and respiratory failure) and 30-d in-hospital mortality. Secondary outcomes were total hospital and intensive care unit length of stay, and duration of ventilator support. RESULTS: About 1360 patients (EPI: 329 and NEPI: 1031) met inclusion criteria (mean age: 54.2 y; standard deviation [SD]: 19.7; 68% male). The mean number of rib fractures was 4.8 (SD: 3.3; 21% bilateral) with a high total burden of injury (mean Injury Severity Score: 19.9 [SD: 8.9]). The overall incidence of respiratory complications was 13% and mortality was 4%. After matching, 204 EPI patients were compared with 204 NEPI patients, with no differences in baseline characteristics. EPI patients experienced more respiratory complications (19% versus 10%, P = 0.009), but no differences in 30-d mortality (5% versus 2%, P = 0.159), duration of mechanical ventilation (EPI: 148 h [SD: 167] versus NEPI: 117 h [SD: 187], P = 0.434), or duration of intensive care unit length of stay (6.5 d [SD: 7.6] versus 5.8 d [SD: 9.1], P = 0.626). Hospital stay was higher in the EPI group (16.6 d [SD: 19.6] vs 12.7 d [SD: 15.2], P = 0.026). CONCLUSIONS: Epidural analgesia is associated with increased respiratory complications without providing mortality benefit after traumatic rib fractures. Alternate analgesic strategies should be investigated to treat these severely injured patients.

What are the Training Gaps for Acquiring Laparoscopic Suturing Skills?

INTRODUCTION: Advanced laparoscopic suturing is considered a challenging skill to acquire. The aim of this study was to investigate the learning process for advanced laparoscopic suturing in the operating room to understand the obstacles trainees face when trying to master the skill. METHODS: A qualitative methodology using semistructured interviews and field observations was used. Data were analyzed using a Grounded Theory approach. Participants were general surgery residents and surgeons with advanced minimally invasive surgery (MIS) experience. RESULTS: Ten MIS surgeons across different institutions and 15 local general surgery residents were interviewed. The semistructured interviews and field observations of 9 advanced MIS operations (27h) yielded the following 6 themes around the acquisition of laparoscopic suturing skills for residents: complexity, training misalignment, variability of opportunities, inconsistency of techniques, lack of feedback, and differing expectations. CONCLUSION: There are several unmet training needs around laparoscopic suturing skills. Training for advanced laparoscopic skills requires more emphasis on coaching and the development of advanced models. This study heralded the need to incorporate advanced laparoscopic skills into the surgical simulation curriculum.

Establishing meaningful benchmarks: the development of a formative feedback tool for advanced laparoscopic suturing.

BACKGROUND: Time and accuracy are commonly used metrics to assess laparoscopic skills in a simulated environment. However, they do not provide trainees with meaningful information about how to improve their skills. The objective of this study was to provide preliminary validity evidence for the creation a formative feedback tool (FFT) for advanced laparoscopic suturing skills. METHODS: Videotapes of senior surgical residents (PGY3-5; SRs) and minimally invasive surgeons (MIS) performing 3 advanced laparoscopic suturing tasks were analyzed: needle handling (NH), suturing under tension (UT), and continuous suturing (CS). A FFT was created based on a grounded theory analysis of interviews with MIS surgeons about the key technical aspects of each task. The FFT was used to assess the videotaped performances of SRs and MIS surgeons by two blinded independent raters. RESULTS: The FFT is composed of three parts: NH contains 10 items, UT 18, and CS 20. Each item was classified according to seven key surgical principles: depth perception, safety, bimanual dexterity, exposure, tissue handling, instrument manipulation, and forward planning. The videotaped performance of SR and MIS surgeons was graded on a 3-point Likert scale ("does well," "needs some improvement," and "does poorly") and scores were calculated as a sum of the points. ICCs for all three tasks were high (NH 0.90, UT 0.87, and CS 0.90). FFT score correlated strongly with combined time and accuracy measurements for UT (0.82, p < 0.01) and CS (0.81, p < 0.01), and moderately for NH (0.65, p < 0.01). MIS surgeons performed significantly better than SRs on UT (p = 0.02) and CS (p = 0.05), while scores on NH were similar (p = 0.57). CONCLUSIONS: A comprehensive tool for providing feedback about advanced laparoscopic suturing skills was developed. The FFT demonstrates evidence for validity as a measure of suturing skills and experience, and provides meaningful information to trainees about how to improve their skills and engage in more deliberate and efficient practice.

Perioperative feedback in surgical training: A systematic review.

BACKGROUND: Changes in surgical training have raised concerns about residents' operative exposure and preparedness for independent practice. One way of addressing this concern is by optimizing teaching and feedback in the operating room (OR). The objective of this study was to perform a systematic review on perioperative teaching and feedback. METHODS: A systematic literature search identified articles from 1994 to 2014 that addressed teaching, feedback, guidance, or debriefing in the perioperative period. Data was extracted according to ENTREQ guidelines, and a qualitative analysis was performed. RESULTS: Thematic analysis of the 26 included studies identified four major topics. Observation of teaching behaviors in the OR described current teaching practices. Identification of effective teaching strategies analyzed teaching behaviors, differentiating positive and negative teaching strategies. Perceptions of teaching behaviors described resident and attending satisfaction with teaching in the OR. Finally models for delivering structured feedback cited examples of feedback strategies and measured their effectiveness. CONCLUSIONS: This study provides an overview of perioperative teaching and feedback for surgical trainees and identifies a need for improved quality and quantity of structured feedback.

Don't fix it if it isn't broken: a survey of preparedness for practice among graduates of Fellowship Council-accredited fellowships.

BACKGROUND: General surgery residency may not adequately prepare residents for independent practice. It is unclear; however, if non-ACGME-accredited fellowships are better meeting training needs. The purpose of this mixed-method study was to determine perceived preparedness for practice and to identify gaps in fellowship training. METHODS: A survey was developed using an iterative qualitative methodology based on interviews and focus groups of graduated fellows and program directors. Five central themes emerged and were used as a framework: professional development, job marketability, autonomy, networking, and practice management. The survey was then circulated by email to fellows who graduated from Fellowship Council (FC)-accredited programs within the past 3 years. RESULTS: Of 201 respondents (response rate = 41 %), 95 and 97 % were highly satisfied with their operative and non-operative experiences; 83 % acquired jobs aligned with their skills and expectations, while 17 % sought additional training after fellowship. Respondents who intended to learn a given procedure felt competent after fellowship to perform 51(85 %) of the 60 procedures listed. They would have liked more experience in advanced therapeutic endoscopy, complex and revisional bariatric surgery, and uncommon laparoscopic procedures such as esophagectomy, adrenalectomy, and common bile duct exploration. Thirty-one percent expressed the desire for more autonomy in the management of complications. Educational gaps existed mostly in areas of coding and billing (42 %), hiring administrative staff (42 %), and managing insurance issues (34 %). CONCLUSIONS: FC-accredited fellowships seem to adequately prepare surgeons for independent practice and bridge training gaps after residency. Graduates are highly satisfied with the individualized training experience and acquire desired jobs aligned with their career goals.

Psychometric properties of the Global Operative Assessment of Laparoscopic Skills (GOALS) using item response theory.

BACKGROUND: The extent to which each item assessed using the Global Operative Assessment of Laparoscopic Skills (GOALS) contributes to the total score remains unknown. The purpose of this study was to evaluate the level of difficulty and discriminative ability of each of the 5 GOALS items using item response theory (IRT). METHODS: A total of 396 GOALS assessments for a variety of laparoscopic procedures over a 12-year time period were included. Threshold parameters of item difficulty and discrimination power were estimated for each item using IRT. RESULTS: The higher slope parameters seen with "bimanual dexterity" and "efficiency" are indicative of greater discriminative ability than "depth perception", "tissue handling", and "autonomy". CONCLUSIONS: IRT psychometric analysis indicates that the 5 GOALS items do not demonstrate uniform difficulty and discriminative power, suggesting that they should not be scored equally. "Bimanual dexterity" and "efficiency" seem to have stronger discrimination. Weighted scores based on these findings could improve the accuracy of assessing individual laparoscopic skills.

Multicenter proficiency benchmarks for advanced laparoscopic suturing tasks.

BACKGROUND: Advanced laparoscopic suturing (LS) tasks were developed based on a needs assessment. Initial validity evidence has been shown. The purpose of this multicenter study was to determine expert proficiency benchmarks for these tasks. METHODS: 6 tasks were included: needle handling (NH), offset-camera forehand suturing (OF), offset-camera backhand suturing (OB), confined space suturing (CF), suturing under tension (UT), and continuous suturing (CS). Minimally invasive surgeons experienced in LS completed the tasks twice. Mean time and median accuracy scores were used to establish the benchmarks. RESULTS: Seventeen MIS surgeons enrolled, from 7 academic centers. Mean (95% CI) time in seconds to complete each task was: NH 169 (149-189), OF 158 (134-181), OB 189 (154-224), CF 181 (156-205), UT 379 (334-423), and CS 416 (354-477). Very few errors in accuracy were made by experts in each of the tasks. CONCLUSIONS: Time- and accuracy-based proficiency benchmarks for 6 advanced LS tasks were established. These benchmarks will be included in an advanced laparoscopic surgery curriculum currently under development.

A Learner-Created Virtual Patient Curriculum for Surgical Residents: Successes and Failures.

OBJECTIVE: To determine the feasibility and effectiveness of a learner-created virtual patient (VP) curriculum for postgraduate year 2 surgical residents. DESIGN: Using a social-constructivist model of learning, we designed a learner-created VP curriculum to help postgraduate year 2 residents prepare for their in-training surgical examination. Each resident was assigned to create a VP curriculum based on the learning objectives for this examination, and VP cases were then disseminated to all residents for completion. To measure the learning effects of the curriculum, participants completed 2 simulated in-training examinations, both at the beginning and at the end of the intervention. Study participants also participated in a focus group and completed an online questionnaire about the perceived learning value of the curriculum. SETTING: The study was conducted at the McGill University Health Centre, a tertiary care hospital in Montreal, Canada. PARTICIPANTS: In total, 24 residents from 7 surgical specialties completed both the pretest and posttest, as well as took part in the creation of a VP curriculum. Of those 24 residents, only 19 residents completed the cases created by their peers, with 7 completing greater than 50% of the cases and 12 completing less than 50%. In all 17 residents responded to the online questionnaire and 11 residents participated in the focus group. RESULTS: The VP curriculum failed to improve scores from pretest (59.6%, standard deviation = 8.1) to posttest (55.4%, standard deviation = 6.6; p = 0.01) on the simulated in-training examination. Nonetheless, survey results demonstrated that most residents felt that creating a VP case (89%) and completing cases created by their peers (71%) had educational value. Overall, 71% preferred active participation in a curriculum to traditional didactic teaching. The focus group identified time-related constraints, concern about the quality of the peer-created cases, and questioning of the relationship between the curriculum and the Surgical Foundations examination as barriers to the success of the curriculum. CONCLUSIONS: Despite the fact that a learner-created VP curriculum did not improve scores on a mock in training examination, residents viewed this intervention as a valuable educational experience. Although there were barriers to the implementation of a learner-created curriculum, it is nonetheless important to try and integrate pedagogical concepts into the instructional design of curricula for surgical residents.

A systematic review of performance assessment tools for laparoscopic cholecystectomy.

BACKGROUND: Multiple tools are available to assess clinical performance of laparoscopic cholecystectomy (LC), but there are no guidelines on how best to implement and interpret them in educational settings. The purpose of this systematic review was to identify and critically appraise LC assessment tools and their measurement properties, in order to make recommendations for their implementation in surgical training. METHODS: A systematic search (1989-2013) was conducted in MEDLINE, Embase, Scopus, Cochrane, and grey literature sources. Evidence for validity (content, response process, internal structure, relations to other variables, and consequences) and the conditions in which the evidence was obtained were evaluated. RESULTS: A total of 54 articles were included for qualitative synthesis. Fifteen technical skills and two non-technical skills assessment tools were identified. The 17 tools were used for either: recorded procedures (nine tools, 60%), direct observation (five tools, 30%), or both (three tools, 18%). Fourteen (82%) tools reported inter-rater reliability and one reported a Generalizability Theory coefficient. Nine (53%) had evidence for validity based on clinical experience and 11 (65%) compared scores to other assessments. Consequences of scores, educational impact, applications to residency training, and how raters were trained were not clearly reported. No studies mentioned cost. CONCLUSIONS: The most commonly reported validity evidence was inter-rater reliability and relationships to other known variables. Consequences of assessments and rater training were not clearly reported. These data and the evidence for validity should be taken into consideration when deciding how to select and implement a tool to assess performance of LC, and especially how to interpret the results.

New models for advanced laparoscopic suturing: taking it to the next level.

BACKGROUND: Current simulations for laparoscopic suturing do not reflect the complexity of the skills required in the operating room. The purpose of this study was to develop three novel advanced suturing tasks with assessment metrics and to collect validity evidence for their measures of suturing skill. METHODS: We developed three tasks based on training gaps identified through a previous needs assessment: needle handling (NH), suturing under tension (UT), and continuous suturing (CS). Minimally invasive surgeons (MIS) and senior surgical residents (SR) completed these tasks and a questionnaire regarding their educational value. Performance was assessed by two raters based on time and accuracy. Validity was assessed by comparing performance according to the level of training and self-reported experience. The inter-rater reliability and internal consistency of the tasks were calculated. RESULTS: Thirty-one subjects (13 MIS, 18 SR) were enrolled in the study (median age 32; 77% male). Compared to the SR group, the MIS group had significantly greater scores on all tasks. While all MIS surgeons completed the three tasks within the allotted time, six (33%) residents could not complete at least one out of the three tasks. Laparoscopic suturing experience correlated positively with the scores of all tasks (NH 0.51, UT 0.70, CS 0.65. p < 0.01). Inter-rater reliability for all tasks was 0.99, and internal consistency was 0.80. The majority of participants agreed that the tasks were relevant to practice, helped improve technical competence, and adequately measured suturing ability. CONCLUSIONS: This study provides validity evidence for three novel advanced laparoscopic suturing tasks. Performance on all tasks correlated significantly with training level and self-reported experience. Integrating these tasks into educational curricula may help improve residents' suturing skills and better prepare residents for the operating room.

Reconstruction after major chest wall resection: can rigid fixation be avoided?

BACKGROUND: Rigid fixation is advocated as the best method to achieve good respiratory outcomes after chest wall resection at the expense of a high complication rate. The following study aims to examine the role of myocutaneous pedicled flaps, with or without soft prosthesis, in the reconstruction of small and large chest wall defects. METHODS: All patients who underwent resection of chest wall tumors between 2003-2010 were identified from a prospectively entered database. Operative and postoperative outcomes were documented. Patients were stratified into 2 separate groups based on the size of the residual chest wall defect; the Small Defect (SD) group (<60 cm(2)) and the Large Defect (LD) group (>60 cm(2)). RESULTS: Thirty-seven patients were identified over a 7-year period: 9 in the SD group and 28 in the LD group. Primary sarcoma was the most common indication for resection (57%). The mean size of the chest wall defect was 50.8 cm(2) in the SD group and 149.4 cm(2) in the LD group (P = .001). All patients underwent reconstruction with autologous tissue, nonrigid prosthesis, or a combination of the two. Prosthesis was used in 11% of patients in the SD group and 61% of patients in the LD group (P = .018). The rate of immediate postoperative extubation was 100% in the SD group and 89% in the LD group (P = .42). The rate of postoperative pneumonia was 7% in the LD group vs 0% in the SD group. The rate of surgical site infection was 7% in the LD group and 0% in the SD group. A subgroup analysis of the LD group demonstrated no statistical differences in any of the measured outcomes between patients in whom mesh prosthesis was used and patients in whom a myocutaneous flap alone was used. However, there was a clinical suggestion of prolonged ventilation in the subgroup where mesh was not used and of higher infection rates in the subgroup where mesh was used. CONCLUSION: Small chest wall defects can be reconstructed with pedicled myocutaneous flaps alone without compromising respiratory outcomes. In carefully selected patients with moderate size defects larger than 60 cm(2), reconstruction with pedicled myocutaneous flap alone offers similar postoperative outcomes as reconstruction with nonrigid prosthesis, at the expense of a possible need for a short period of mechanical ventilation.