The learning curve for transoral incisionless fundoplication
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ABSTRACT:
SUBMITTER: Dbouk M
PROVIDER: S-EPMC8589558 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description: Not available
| S-EPMC7570963 | biostudies-literature
Project description:BACKGROUND: A novel transoral incisionless fundoplication (TIF) procedure using the EsophyX system with SerosaFuse fasteners was designed to reconstruct a full-thickness valve at the gastroesophageal junction through tailored delivery of multiple fasteners during a single-device insertion. The safety and efficacy of TIF for treating gastroesophageal reflux disease (GERD) were evaluated in a prospective multicenter trial. METHODS: Patients (n = 86) with chronic GERD treated with proton pump inhibitors (PPIs) were enrolled. Exclusion criteria included an irreducible hiatal hernia > 2 cm. RESULTS: The TIF procedure (n = 84) reduced all hiatal hernias (n = 49) and constructed valves measuring 4 cm (2-6 cm) and 230 degrees (160 degrees -300 degrees ). Serious adverse events consisted of two esophageal perforations upon device insertion and one case of postoperative intraluminal bleeding. Other adverse events were mild and transient. At 12 months, aggregate (n = 79) and stratified Hill grade I tight (n = 21) results showed 73% and 86% of patients with >or=50% improvement in GERD health-related quality of life (HRQL) scores, 85% discontinuation of daily PPI use, and 81% complete cessation of PPIs; 37% and 48% normalization of esophageal acid exposure; 60% and 89% hiatal hernia reduction; and 62% and 80% esophagitis reduction, respectively. More than 50% of patients with Hill grade I tight valves had a normalized cardia circumference. Resting pressure of the lower esophageal sphincter (LES) was improved significantly (p < 0.001), by 53%. EsophyX-TIF cured GERD in 56% of patients based on their symptom reduction and PPI discontinuation. CONCLUSION: The 12-month results showed that EsophyX-TIF was safe and effective in improving quality of life and for reducing symptoms, PPI use, hiatal hernia, and esophagitis, as well as increasing the LES resting pressure and normalizing esophageal pH and cardia circumference in chronic GERD patients.
| S-EPMC2490723 | biostudies-other
Project description:Background and study aims Few reports exist about long-term outcomes of transoral incisionless fundoplication (TIF) for treating refractory gastro-esophageal reflux disease (GERD). Methods A literature search of four major scientific databases was performed up to May 2020 for studies reporting on more than 3-year outcomes of TIF. Data on atient satisfaction, proton pump inhibitor (PPI) daily consumption, PPI use reduction, GERD health-related quality-of-life (GERD-HRQL) score, and normalization of heartburn and regurgitation scores were pooled and summarized with forest plots. Publication bias and heterogeneity were explored. Results Overall, eight studies (418 patients, 232 men; 55.5 %) with a mean follow-up of 5.3 years (range: 3-10 years) were included. The pooled proportion of patient-reported satisfaction before and after TIF was 12.3 % (95 % CI:12.3-35.1 %, I 2 = 87.4 %) and 70.6 % (95 % CI:51.2-84.6, I 2 = 80 %), respectively, corresponding to an odds ratio of 21.4 (95 % CI:3.27-140.5). Pooled rates of patients completely off PPIs and on occasional PPIs were 53.8 % (95 %CI: 42.0 %-65.1 %) and 75.8 % (95 %CI: 67.6-82.6), respectively. The pooled estimated mean GERD-HRQL scores off PPI before and after TIF werey 26.1 (95 %CI: 21.5-30.7; range: 20.0-35.5) and 5.9, respectively (95 %CI:0.35.1-11.4; range: 5.3-9.8; P < 0.001). The overall pooled rates of heartburn and regurgitation scores normalization were 73.0 % (95 %CI: 0.62-0.82) and 86 %, respectively (95 %CI: 75.0-91.0 %). Conclusion Our study shows that TIF appears to offer a long-term safe therapeutic option for selected patients with GERD who refuse life-long medical therapy or surgery, are intolerant to PPIs, or are at increased surgical risk.
| S-EPMC7857958 | biostudies-literature
Project description:Objective To define the learning curve for transoral endoscopic thyroidectomy via the vestibular approach (TOETVA). Study Design Case series with planned data collection. Setting Tertiary care academic hospital. Subjects and Methods Included patients were those who met the 2015 American Thyroid Association guidelines for lobectomy and our group's previously documented indications for TOETVA. Operative time (incision to closure) was used as a surrogate for procedural proficiency and plotted as a function of case number to determine a learning curve. A simple moving average of operative time was then calculated, with the proficiency case defined as the case number where the slope of this curve changed. Demographic/characteristic data, outcomes, and complications were compared between the skill acquisition period (case 1 to proficiency case) and the proficiency period (remaining cases). A linear regression model was then used to calculate and compare the slopes of the skill acquisition and proficiency periods in the "operative time versus case number" plot. Results Thirty cases were attempted, with a procedural success rate of 29 of 30 (94%) and no incidence of permanent mental nerve or recurrent laryngeal nerve injury. The proficiency case was case 11. There was a statistically significant difference between the skill acquisition and proficiency periods in slopes of the linear regressions (-16.7 vs -0.3, respectively; P < .001) and median operative times (191 vs 119 minutes, P < .001). There was no difference in demographics, procedural success rate, or complication rate between the periods. Conclusions The learning curve for TOETVA was 11 cases for the surgeon evaluated in this series.
| S-EPMC6214162 | biostudies-literature
Project description:PurposeAlthough laparoscopic Heller myotomy and Dor fundoplication (LHD) is widely performed to address achalasia, little is known about the learning curve for this technique. We assessed the learning curve for performing LHD.MethodsOf the 514 cases with LHD performed between August 1994 and March 2016, the surgical outcomes of 463 cases were evaluated after excluding 50 cases with reduced port surgery and one case with the simultaneous performance of laparoscopic distal partial gastrectomy. A receiver operating characteristic (ROC) curve analysis was used to identify the cut-off value for the number of surgical experiences necessary to become proficient with LHD, which was defined as the completion of the learning curve.ResultsWe defined the completion of the learning curve when the following 3 conditions were satisfied. 1) The operation time was less than 165 minutes. 2) There was no blood loss. 3) There was no intraoperative complication. In order to establish the appropriate number of surgical experiences required to complete the learning curve, the cut-off value was evaluated by using a ROC curve (AUC 0.717, p < 0.001). Finally, we identified the cut-off value as 16 surgical cases (sensitivity 0.706, specificity 0.646).ConclusionLearning curve seems to complete after performing 16 cases.
| S-EPMC5501549 | biostudies-literature
Project description: Not available
| S-EPMC8043814 | biostudies-literature
Project description:Many studies have looked at the learning curve associated with laparoscopic Nissen fundoplication (LNF) in a given institution. This study looks at the learning curve of a single surgeon with a large cohort of patients over a 10-year period. Prospective data were collected on 400 patients undergoing laparoscopic fundoplication for over 10 years. The patients were grouped consecutively into cohorts of 50 patients. The operating time, the length of postoperative hospital stay, the conversion rate to open operation, the postoperative dilatation rate, and the reoperation rate were analyzed. Results showed that the mean length of operative time decreased from 143 min in the first 50 patients to 86 min in the last 50 patients. The mean postoperative length of hospital stay decreased from 3.7 days initially to 1.2 days latterly. There was a 14% conversion to open operation rate in the first cohort compared with a 2% rate in the last cohort. Fourteen percent of patients required reoperation in the first cohort and 6% in the last cohort. Sixteen percent required postoperative dilatation in the first cohort. None of the last 150 patients required dilatation. In conclusion, laparoscopic fundoplication is a safe and effective operation for patients with gastroesophageal reflux disease. New techniques and better instrumentation were introduced in the early era of LNF. The learning curve, however, continues well beyond the first 20 patients.
| S-EPMC1852390 | biostudies-other
Project description:ObjectivesIntraoperative neuromonitoring has not been routinely applied in early experience with the transoral endoscopic thyroidectomy vestibular approach (TOETVA). Because the preparation and surgical interventions are much different from conventional thyroidectomies, most endocrine surgeons willing to adapt to TOETVA lack access to information regarding the practice pattern and proficiency in the learning curve. We aimed to investigate the outcomes and to define the learning curve for TOETVA in this study.MethodsA retrospective analysis was used on patients who underwent TOETVA at our hospital between December 2016 and July 2019. The cumulative sum graphic model was used to implement the learning curve as a surrogate for procedural proficiency.ResultsThe 119 patients had a mean age of 44.65 years and a mean body mass index of 22.49 k/m2, including 107 women, 20 thyroiditis, and 106 hemithyroidectomy. The learning curve revealed two phases, an initial (35 cases) and a mature (84 cases) phase, for surgeons based on operation time (144.2 vs. 114.2 min, p = 0.0001). There were more bilateral thyroidectomies (15.5% vs. 0, p = 0.0100), larger indicated nodules (6.06 cm3 vs. 3.32 cm3, p = 0.0468), or larger thyroids to resect (16.38 cm3 vs. 8.75 cm3, p = 0.0001) in the mature phase. Procedure-related complications decreased significantly in the mature phase in comparison to the initial phase (3.57% vs. 31.43%, p = 0.0001).ConclusionsThe learning curve of TOETVA with neuromonitoring is 35 cases. With the accumulation of proficiency, the indications will expand. Step-by-step improvements from the experience of each case can reduce procedure-related complications.
| S-EPMC8594485 | biostudies-literature
Project description:BackgroundPreoperative factors predicting symptomatic improvement after transoral fundoplication (TF) in chronic gastroesophageal reflux disease (GERD) patients with persistent symptoms on proton-pump inhibitors (PPIs) therapy have not been elucidated fully.MethodsUnivariate and multivariate logistic regression analyses were performed on data from 158 consecutive patients who underwent TF with the EsophyX device between January 2010 and June 2012 in 14 community centers. Variables included age, gender, body mass index, GERD duration, PPIs therapy duration, presence of hiatal hernia, esophagitis, Hill grade, quality of life scores (QOL) on PPIs, % total time pH < 4, and DeMeester score on reflux testing off PPIs.ResultsAll patients suffered from typical GERD symptoms. Additionally, 78% (124/158) of patients suffered from atypical symptoms. Six percent (10/158) with recurrent GERD symptoms refractory to PPI therapy underwent revisional procedure (9 laparoscopic Nissen, 1 TF). Median follow-up was 22 (range 10-43) months. For patients with typical symptoms, univariate analyses revealed 4 preoperative factors predictive of successful outcomes: age ≥ 50 [odds ratio (OR) = 2.4, 95% confidence interval (CI) = 1.2-4.8, p = 0.014], GERD Health-related Quality of Life score (GERD-HRQL) ≥ 15 on PPIs (OR = 6.0, CI = 1.2-29.4, p = 0.026, Reflux Symptom Index score > 13 on PPIs (OR = 2.4, CI = 1.1-5.2, p = 0.027), and Gastroesophageal Reflux Symptom Score ≥ 18 on PPIs (OR = 2.6, CI = 1.2-5.8, p = 0.018). Age and GERD-HRQL score remained significant predictors by multivariate analysis. For patients with atypical symptoms, only GERD-HRQL score ≥ 15 on PPIs (OR = 9.9, CI = 0.9-4.6, p = 0.036) was associated with successful outcomes.ConclusionsElevated preoperative QOL scores on PPIs and age ≥ 50 were most closely associated with successful outcome of TF in patients with persistent symptoms despite medical therapy.
| S-EPMC4186971 | biostudies-literature
Project description:Introduction:?Increased esophageal acid exposure is seen in a large percentage of patients with achalasia who undergo peroral endoscopic myotomy (POEM). Endoscopic transoral fundoplication (TIF) is a novel endoscopic technique for the management of patients with chronic gastroesophageal reflux (GERD). We present the first case series evaluating the role of TIF post-POEM. Methods:?Consecutive patients 18 years or older from our academic institution who underwent a POEM procedure and subsequently underwent TIF for symptomatic reflux or regurgitation between December 2014 and June 2017 were included. The primary outcome was discontinuation of proton-pump inhibitor (PPI) use and healing of esophagitis (when initially present) on post-procedure esophagogastroduodenoscopy (EGD). Technical success was defined as successful completion of the endoscopic fundoplication. Adverse events (AEs) were recorded for all patients. Results?:Five patients were included (60?% male, average age 55?±?14 years). Technical success was achieved in 100?% of patients. Discontinuation of PPI use was achieved in 5/5 patients (100?%). Three patients had esophagitis pre-procedure and all were noted to have resolution of inflammation on post-procedure EGD. No adverse events were noted. Mean follow-up time was 27 months (range 5?-?34 months). Conclusion:?TIF post-POEM appears feasible, safe, and efficacious in improving symptoms and esophagitis, decreasing long-term risks of acid exposure, and decreasing risks of long-term PPI use in patients post-POEM in this small cohort of patients. Larger studies are needed to confirm these initial findings.
| S-EPMC5943699 | biostudies-literature