Gabriela Ghitulescu - Academia.edu (original) (raw)

Papers by Gabriela Ghitulescu

Surgical Endoscopy

Introduction The objective of this study was to evaluate the impact of preoperative bowel stimula... more Introduction The objective of this study was to evaluate the impact of preoperative bowel stimulation on the development of postoperative ileus (POI) after loop ileostomy closure. Methods This was a multicenter, randomized controlled trial (NCT025596350) including adult (≥ 18 years old) patients who underwent elective loop ileostomy closure at 7 participating hospitals. Participants were randomly assigned (1:1) using a centralized computer-generated sequence with block randomization to either preoperative bowel stimulation or no stimulation (control group). Bowel stimulation consisted of 10 outpatient sessions within the 3 weeks prior to ileostomy closure and was performed by trained Enterostomal Therapy nurses. The primary outcome was POI, defined as an intolerance to oral food in the absence of clinical or radiological signs of obstruction, on or after postoperative day 3, that either (a) required nasogastric tube insertion; or (b) was associated with two of the following: nausea/...

Surgery, 2021

The purpose of this study was to describe postoperative bowel dysfunction after restorative proct... more The purpose of this study was to describe postoperative bowel dysfunction after restorative proctectomy, and to identify factors associated with its development. Patients who underwent restorative proctectomy for rectal cancer between April 1998 and November 2018 were identified from the Hospital Episode Statistics database and linked to the Clinical Practice Research Datalink for postoperative follow-up. Bowel dysfunction was defined according to relevant symptom-based read codes and medication prescription-product codes. A Cox proportional hazards model was performed to identify factors associated with postoperative bowel dysfunction, adjusting for relevant covariates. In total, 2,197 patients were included. The median age was 70.0 (interquartile range: 62.0-77.0) years old, and the majority (59.2%) of patients were male. After a median follow-up of 51.6 (24.0-90.0) months, bowel dysfunction was identified in 620 (28.2%) patients. Risk factors for postoperative bowel dysfunction included extremes of age (<40 years old: adjusted hazards ratio 2.35, 95% confidence interval 1.18-4.65; 70-79 years old: adjusted hazards ratio 1.25, 95% confidence interval 1.03-1.52), radiotherapy (adjusted hazards ratio 1.94, 95% confidence interval 1.56-2.42), distal tumors (adjusted hazards ratio 1.62, 95% confidence interval 1.34-1.94), history of diverting ostomy (adjusted hazards ratio 1.58, 95% confidence interval 1.33-1.89), and anastomotic leak (adjusted hazards ratio 1.48, 95% confidence interval 1.06-2.05). A minimally invasive surgical approach was protective for postoperative bowel dysfunction (adjusted hazards ratio 0.68, 95% confidence interval 0.53-0.86). Bowel dysfunction was common after restorative proctectomy, and several patient, disease, and treatment-level factors were associated with its development.

Surgical Endoscopy

Purpose The COVID-19 pandemic resulted in a partial to total shutdown of endoscopy in many health... more Purpose The COVID-19 pandemic resulted in a partial to total shutdown of endoscopy in many healthcare centers. This study aims to quantify the impact of the reduction in colonoscopies on colorectal cancer (CRC) detection and screening. Methods After institutional ethics board approval, the endoscopy database at an academic tertiary-care center in Montreal, Canada, was searched for all colonoscopies performed from during the first wave locally (March-June 2020), and during the ramp up period where endoscopy service resumed (July to August 2020). We compared these periods to the same periods in 2019, the pre-pandemic periods. The indications, CRC and adenoma detection rates, as well as the prioritization of urgent procedures were compared. Results In the first wave, only 462 colonoscopies were performed, compared to 2515 in the same period in 2019, an 82% reduction. The ramp up period saw 843 colonoscopies performed compared to 1328 in 2019, a 35% reduction. Urgent and inpatient colonoscopies numbers increased (324 (24.8%) vs. 220 (5.7%)) while surveillance and high-risk screening colonoscopies fell (376 (28.8%) vs 1869 (48.6%)). Emergency access to colonoscopy was preserved with a median time to endoscopy of < 1 day (IQR 0,1) in both pandemic periods. During the pandemic periods, there was an absolute reduction in CRC diagnosis of 28, despite the CRC detection per colonoscopy rate increasing slightly in the first wave from 1.7% (44) to 3.9% (18), and in the ramp up period from 2.5% (33) to 3.6% (31). The rate of adenoma detection per colonoscopy did not increase significantly between the pre-and pandemic periods, resulting in reduction in adenoma removal in 723 patients. Discussion The restriction of access to colonoscopy resulted in a significant reduction in screening and surveillance of high-risk patients, adenomas removed, and CRCs diagnosed. Clinicians and patients will face the oncologic ramifications this the coming years. Keywords COVID-19 pandemic • Colonoscopy • Colorectal cancer In December 2019, a novel virus emerged quickly spreading worldwide. By March 2020, the Coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) was declared a

Surgery, 2022

BACKGROUND The purpose of this study was to determine if observational therapy is noninferior to ... more BACKGROUND The purpose of this study was to determine if observational therapy is noninferior to antibiotics for acute uncomplicated diverticulitis according to clinically relevant margins. METHODS MEDLINE, EMBASE, and Cochrane were systematically searched by 2 independent reviewers to identify comparative studies of observational therapy versus antibiotics for acute uncomplicated diverticulitis. Non-inferiority margins (ΔNI) for each outcome were based on Delphi consensus including 50 patients and 55 physicians: persistent diverticulitis (ΔNI = 4.0%), progression to complicated diverticulitis (ΔNI = 3.0%), and time to recovery (ΔNI = 5 days). Risk differences and mean differences were pooled using random-effects meta-analysis. One-sided 90% confidence intervals and Z-tests were used to determine non-inferiority. A sensitivity analysis was performed, excluding patients post hoc determined to have complicated diverticulitis. RESULTS Nine studies (3 randomized controlled trials, 6 observational studies) met inclusion criteria: observational therapy (n = 2,011) versus antibiotics (n = 1,144). Observational therapy was noninferior to antibiotics regarding the risk of persistent diverticulitis (pooled risk differences: -0.39%, 90% CI -3.22 to 2.44%, ΔNI: 4.0%, PNI < 0.001; I2 = 66%) and progression to complicated diverticulitis (pooled risk differences: -0.030%, 90% CI -0.99 to 0.92%, ΔNI: 3.0%, PNI < 0.001; I2 = 0%). On sensitivity analysis, observational therapy remained noninferior for both outcomes. When stratified by study design, observational therapy also remained noninferior for both outcomes among randomized controlled trials only. Only 1 study reported on time to recovery as a continuous outcome, with no statistical difference between antibiotics and observational therapy. CONCLUSION According to clinically relevant ΔNIs, observational therapy was noninferior to antibiotics for the treatment of acute uncomplicated diverticulitis with regard to persistent diverticulitis and progression to complicated diverticulitis.

Surgical Endoscopy, 2022

Implementation of early discharge in colorectal surgery has been effective in improving patient s... more Implementation of early discharge in colorectal surgery has been effective in improving patient satisfaction and reducing healthcare costs. Readmission rates following early discharge among colorectal cancer patients are believed to be low, however, remain understudied. The objectives of this study were: (i) to describe trends in early post-operative discharge and the associated hospitalization costs; (ii) to explore patient outcomes and resource utilization following early discharge; and (ii) to identify predictors of readmission following early discharge. This was a retrospective cohort study using the Nationwide Readmissions Database. Adult patients admitted with a primary colorectal neoplasm who underwent colectomy or proctectomy between 2010 and 2017 were identified using ICD-9/10 codes. The exposure of interest was early post-operative discharge defined as ≤ 3 days from surgery. Main outcome measures were 30-day readmissions, post-operative complication rates, LOS and cost. In total, 342,242 patients were identified, and of those, 51,977 patients (15.2%) had early discharges. During the study period, the proportion of early discharges significantly increased (R2 = 0.94), from 9.9 to 23.4%, while readmission rates in this group remained unchanged (mean 7.3% ± 0.5). Complications that required bounceback readmission (within 7 days) after early discharge, rather than during index admission, were an independent predictor of longer overall LOS (ß = 0.044, p < 0.001) and higher hospitalization costs (ß = 0.031, p < 0.001). On multiple logistic regression, factors independently associated with bounceback readmission following early discharge were: male gender (OR = 1.47, 95%CI 1.33–1.63); open surgery (OR = 1.37, 95%CI 1.23–1.52); presence of stoma (OR = 1.51, 95%CI 1.22–1.87); transfer to facility or discharge with home health service (OR = 1.53, 95%CI 1.34–1.75); and Medicare/Medicaid insurance (OR = 1.34, 95%CI 1.14–1.57), among others. Early post-operative discharge of colorectal cancer patients is increasing despite a lack of improvement in readmission rates and an overall increase in hospitalization costs. Premature discharge of select patients may result in readmissions due to critical complications related to surgery resulting in increased resource utilization.

Journal of The American College of Surgeons, 2017

BMJ Open, 2020

Introduction Low anterior resection syndrome (LARS) is described as disordered bowel function aft... more Introduction Low anterior resection syndrome (LARS) is described as disordered bowel function after rectal resection that leads to a detriment in quality of life, and affects the majority of individuals following restorative proctectomy for rectal cancer. The management of LARS includes personalised troubleshooting and effective self-management behaviours. Thus, affected individuals need to be well informed and appropriately engaged in their own LARS management. This manuscript describes the development of a LARS patient-centred programme (LPCP) and the study protocol for its evaluation in a randomised controlled trial. Methods and analysis This will be a multicentre, randomised, assessor-blind, parallel-groups, pragmatic trial evaluating the impact of an LPCP, consisting of an informational booklet, patient diaries and nurse support, on patient-reported outcomes after restorative proctectomy for rectal cancer. The informational booklet was developed by a multidisciplinary LARS team...

Surgical Endoscopy, 2003

The McGill Inanimate System for Training and Evaluation of Laparoscopic Skills (MISTELS) was deve... more The McGill Inanimate System for Training and Evaluation of Laparoscopic Skills (MISTELS) was developed to assess laparoscopic skills and to score them objectively. This system has been described previously. The purpose of the current study was to determine a pass/fail threshold. In this study, 165 individuals were tested and grouped according to their clinical competency in laparoscopic surgery. The noncompetent group consisted of medical students and surgical residents in their first 2 years of training (n = 83). The competent group consisted of chief general surgical residents in their last year of training, laparoscopy fellows, and practicing laparoscopic surgeons (n = 82). The Mann-Whitney U test was used to evaluate differences in task performance between the two groups. There was a significant difference in total scores and individual MISTELS task scores between the noncompetent and competent laparoscopic surgeons (189 vs 372.5; p <0.0001). By setting specific pass/fail total score thresholds (cutoff scores), competent surgeons can be discriminated from noncompetent surgeons. An objective pass/fail evaluation can be given to individuals tested with the MISTELS system.

Journal of the American College of Surgeons, 2004

BACKGROUND: Technical skills of residents have traditionally been evaluated using subjective In-T... more BACKGROUND: Technical skills of residents have traditionally been evaluated using subjective In-Training Evaluation Reports (ITERs). We have developed the McGill Inanimate System for Training and Evaluation of Laparoscopic Skills (MISTELS), an objective measure of laparoscopic technical ability. The purpose of the study was to assess the concurrent validity of the MISTELS by exploring the relationship between MISTELS score and ITER assessment. STUDY DESIGN: Fifty surgery residents were assessed on the MISTELS system. Concurrent ITER assessments of technical skill were collected, and the proportion of superior ratings for the year was calculated. Statistical comparisons were performed by ANOVA and chi-square analysis. The Pearson correlation coefficient was used to compare the scores in the MISTELS with the ITER ratings. RESULTS: The 50 residents received 277 ITERs for the year, of which 103 (37%) were "superior," 170 (61%) "satisfactory," 4 (1%) "borderline," and 0 "unsatisfactory." The MISTELS score correlated moderately well with the proportion of superior ITER scores (r ϭ 0.51, p Ͻ 0.01). Residents who passed the MISTELS had a higher proportion of superior ITER assessments than those who failed the MISTELS (p ϭ 0.02), but residents who performed below their expected level on the MISTELS still received mainly satisfactory ITERs (82 Ϯ 18%). CONCLUSIONS: The ITER assessment is poor at identifying residents with below-average technical skills. Residents who perform well in the MISTELS laparoscopic simulator also have better ITER evaluations, providing evidence for the concurrent validity of the MISTELS. Multiple assessment instruments are recommended for assessment of technical competency.

Annals of Surgery, 2004

To assess the McGill Inanimate System for Training and Evaluation of Laparoscopic Skills (MISTELS... more To assess the McGill Inanimate System for Training and Evaluation of Laparoscopic Skills (MISTELS) physical laparoscopic simulator for construct and predictive validity and for its educational utility. Summary Background Data: MISTELS is the physical simulator incorporated by the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) in their Fundamentals of Laparoscopic Surgery (FLS) program. MISTELS' metrics have been shown to have high interrater and test-retest reliability and to correlate with skill in animal surgery. Methods: Over 200 surgeons and trainees from 5 countries were assessed using MISTELS in a series of experiments to assess the validity of the system and to evaluate whether practicing MISTELS basic skills (transferring) would result in skill acquisition transferable to complex laparoscopic tasks (suturing). Results: Face validity was confirmed through questioning 44 experienced laparoscopic surgeons using global rating scales. MIS-TELS scores increased progressively with increasing laparoscopic experience (n ϭ 215, P Ͻ 0.0001), and residents followed over time improved their scores (n ϭ 24, P Ͻ 0.0001), evidence of construct validity. Results in the host institution did not differ from 5 beta sites (n ϭ 215, external validity). MISTELS scores correlated with a highly reliable validated intraoperative rating of technical skill during laparoscopic cholecystectomy (n ϭ 19, r ϭ 0.81, P Ͻ 0.0004; concurrent validity). Novice laparoscopists were randomized to practice/no practice of the transfer drill for 4 weeks. Improvement in intracorporeal suturing skill was significantly related to practice but not to baseline ability, career goals, or gender (P Ͻ 0.001). Conclusion: MISTELS is a practical and inexpensive inanimate system developed to teach and measure technical skills in laparoscopy. This system is reliable, valid, and a useful educational tool.

Annals of Surgery, 1994

The authors determined the most useful predictors of common bile duct (CBD) stones as diagnosed b... more The authors determined the most useful predictors of common bile duct (CBD) stones as diagnosed by endoscopic retrograde cholangiopancreatography (ERCP) in patients who underwent laparoscopic cholecystectomy (LC). Methods Prospective and retrospective collection of historical, biochemical and ultrasonographic data was used. Receiver operating characteristics curve analysis was used to determine optimal biochemical cutoff values. Multivariate analysis using logistic regression with generation of the best model identifying independent predictors of CBD stones also was employed. Prospective validation of the model was performed on an independent group of patients. Results Endoscopic retrograde cholangiopancreatographies were performed before LC in 106 patients, and after LC in 33. Only four of ten clinical variables evaluated independently predicted the presence of CBD stones. The optimal model predicted a 94% probability of CBD stones in a patient older than 55 years of age who presented with an elevated bilirubin (over 30 ,umol/L) and positive ultrasound findings (a dilated CBD, and a CBD stone seen on ultrasound). This model was validated prospectively in a subsequent series of 49 patients in which the probability of CBD stone was only 8% when all four predictors were absent. Conclusions The identified independent clinical predictors of a CBD stone helps select a population of symptomatic gallstone bearers who benefit most from cholangiographic assessment. Laparoscopic cholecystectomy (LC) has become the now treated this way.2 However, 3% to 33% ofall patients new therapeutic gold standard' in uncomplicated symp-with symptomatic gallstones may bear associated comtomatic cholelithiasis, and at least 80% of all patients are mon bile duct (CBD) stones.3-7 The optimal approach to

Surgical Endoscopy, 2006

Background: The McGill Inanimate System for Training and Evaluation of Laparoscopic Skills (MISTE... more Background: The McGill Inanimate System for Training and Evaluation of Laparoscopic Skills (MISTELS) is a series of five tasks with an objective scoring system. The purpose of this study was to estimate the interrater and test-retest reliability of the MISTELS metrics and to assess their internal consistency. Methods: To determine interrater reliability, two trained observers scored 10 subjects, either live or on tape. Testretest reliability was assessed by having 12 subjects perform two tests, the second immediately following the first. Interrater and test-retest reliability were assessed using intraclass correlation coefficients. Internal consistency between tasks was estimated using CronbachÕs alpha. Results: The interrater and test-retest reliabilities for the total scores were both excellent at 0.998 [95% confidence interval (CI), 0.985-1.00] and 0.892 (95% CI, 0.665-0.968), respectively. CronbachÕs alpha for the first assessment of the test-retest was 0.86. Conclusions: The MISTELS metrics have excellent reliability, which exceeds the threshold level of 0.8 required for high-stakes evaluations. These findings support the use of MISTELS for evaluation in many different settings, including residency training programs.

Journal of the American College of Surgeons

Surgical Endoscopy

Surgery, 2021

Surgical Endoscopy

Surgery, 2022

Surgical Endoscopy, 2022

Journal of The American College of Surgeons, 2017

BMJ Open, 2020

Surgical Endoscopy, 2003

Journal of the American College of Surgeons, 2004

Annals of Surgery, 2004

Annals of Surgery, 1994

Surgical Endoscopy, 2006

Journal of the American College of Surgeons