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AimsNumerous reports have addressed the feasibility and safety of robotic-assisted (RALF) and conventional laparoscopic fundoplication (CLF). Long-term follow-up after direct comparison of these two minimally invasive approaches is scarce. The aim of the present study was to assess long-term disease-specific symptoms and quality of life (QOL) in patients with gastroesophageal reflux disease (GERD) treated with RALF or CLF after 12 years in the randomized ROLAF trial.MethodsIn the ROLAF trial 40 patients with GERD were randomized to RALF (n = 20) or CLF (n = 20) between August 2004 and December 2005. At 12 years after surgery, all patients were invited to complete the standardized Gastrointestinal Symptom Rating Scale (GSRS) and the Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD). Failure of treatment was assessed according to Lundell score.ResultsThe GSRS score was similar for RALF (n = 15) and CLF (n = 15) at 12 years´ follow-up (2.1 ± 0.7 vs. 2.2 ± 1.3, p = 0.740). There was no difference in QOLRAD score (RALF 6.4 ± 1.2; CLF 6.4 ± 1.5, p = 0.656) and the QOLRAD score sub items. Long-term failure of treatment according to the definition by Lundell was not different between RALF and CLF [46% (6/13) vs. 33% (4/12), p = 0.806].ConclusionIn accordance with previous short-term outcome studies, the long-term results 12 years after surgery showed no difference between RALF and CLF regarding postoperative symptoms, QOL and failure of treatment. Relief of symptoms and patient satisfaction were high after both procedures on the long-term. Registration number: DRKS00014690 (https://www.drks.de).

Background The type of fundoplication that should be performed in conjunction with Heller myotomy for esophageal achalasia is controversial. We prospectively compared anterior fundoplication (Dor) with partial posterior fundoplication (Toupet) in patients undergoing laparoscopic Heller myotomy. Methods A multicenter, prospective, randomized-controlled trial was initiated to compare Dor versus Toupet fundoplication after laparoscopic Heller myotomy. Outcome measures were symptomatic GERD scores (0–4, five-point Likert scale questionnaire) and 24-h pH testing at 6–12 months after surgery. Data are mean ± SD. Statistical analysis was by Mann–Whitney U test, Wilcoxon signed rank test, and Freidman’s test. Results Sixty of 85 originally enrolled and randomized patients who underwent 36 Dor and 24 Toupet fundoplications had follow-up data per protocol for analysis. Dor and Toupet groups were similar in age (46.8 vs. 51.7 years) and gender (52.8 vs. 62.5% male). pH studies at 6–12 months in 43 patients (72%: Dor n  = 24 and Toupet n  = 19) showed total DeMeester scores and % time pH < 4 were not significant between the two groups. Abnormal acid reflux was present in 10 of 24 Dor group patients (41.7%) and in 4 of 19 Toupet patients (21.0%) ( p  = 0.152). Dysphagia and regurgitation symptom scores improved significantly in both groups compared to preoperative scores. No significant differences in any esophageal symptoms were noted between the two groups preoperatively or at follow-up. SF-36 quality-of-life measures changed significantly from pre- to postoperative for five of ten domains in the Dor group and seven of ten in the Toupet patients (not significant between groups). Conclusion Laparoscopic Heller myotomy provides significant improvement in dysphagia and regurgitation symptoms in achalasia patients regardless of the type of partial fundoplication. Although a higher percentage of patients in the Dor group had abnormal 24-h pH test results compared to those of patients who underwent Toupet, the differences were not statistically significant.

In patients with achalasia, symptom reduction at 2 years was not superior with laparoscopic Heller's myotomy (LHM) as compared with pneumatic dilation. Perforation of the esophagus occurred in 4% of patients with pneumatic dilation, and mucosal tears occurred in 12% with LHM. Achalasia is an esophageal motor disorder that is characterized clinically by dysphagia, chest pain, and regurgitation of undigested food. These symptoms result from the absence of esophageal peristalsis combined with a defective relaxation of the lower esophageal sphincter. 1 Currently, treatment consists mainly of endoscopic pneumatic dilation or laparoscopic Heller's myotomy (LHM). For many years, repeated endoscopic pneumatic dilation has been the treatment of choice, leading to therapeutic success in 70 to 80% of cases. 2 With the introduction of minimally invasive surgery, the surgical approach has gained considerable interest, with LHM combined with an antireflux procedure considered to be the procedure . . .

Background Four randomized controlled trials have demonstrated the short-term efficacy and safety of transoral esophagogastric fundoplication (TF) performed with the EsophyX ® device in eliminating troublesome gastroesophageal reflux disease (GERD) symptoms in well-selected patient populations. The aim of this study was to assess the durability of these outcomes at 3 years post-procedure. Methods The TF EsophyX versus Medical PPI Open Label trial was conducted in seven US sites. Between June and August 2012, we enrolled patients with small (<2 cm) or absent hiatal hernias who suffered from troublesome GERD symptoms while on PPI therapy for at least 6 months and had abnormal esophageal acid exposure (EAE). Randomization was to TF group ( n  = 40) or to PPI group ( n  = 23). Following evaluation at 6 months, all remaining PPI patients ( n  = 21) elected to undergo crossover to TF. Fifty-two patients were assessed at 3 years for (1) GERD symptom resolution using three GERD-specific quality of life questionnaires, (2) healing of esophagitis using endoscopy, (3) EAE using 48-h Bravo testing, and (4) discontinuation of PPI use. Two patients who underwent revisional procedures by year 3 were included in the final analysis. Results At 3-year follow-up, elimination of troublesome regurgitation and all atypical symptoms was reported by 90 % (37/41) and 88 % (42/48) of patients, respectively. The mean Reflux Symptom Index score improved from 22.2 (9.2) on PPIs at screening to 4 (7.1) off PPIs 3 years post-TF, p  < 0.0001. The mean total % time pH <4 improved from 10.5 (3.5) to 7.8 (5.7), p  = 0.0283. Esophagitis was healed in 86 % (19/22) of patients. At the end of study, 71 % (37/52) of patients had discontinued PPI therapy. All outcome measures remained stable between 1-, 2-, and 3-year follow-ups. Conclusion This study demonstrates that TF can be used to achieve long-term control of chronic GERD symptoms, healing of esophagitis, and improvement in EAE.

BackgroundCurrently very little is known about the impact of anti-reflux surgery on extra-esophageal manifestations of gastroesophageal reflux disease (GERD) when compared with the typical symptoms of reflux. The aim of our study was to evaluate the clinical effect of total (360°) and partial (270°) laparoscopic fundoplication on extraesophageal GERD symptoms.MethodsOne hundred and twenty patients with documented extraesophageal GERD symptoms were randomized to either undergo floppy Nissen (n= 60) or Toupet fundoplication (n= 60). Symptom scores of throat clearing, globus sensation, cough, throat pain, and vocal changes were prospectively evaluated. A reflux symptom index (RSI) questionnaire was used to accurately document the improvement of extraesophageal symptoms. Quality of life was determined according to the laryngopharyngeal reflux–health-related quality of life (LPR–HRQL) questionnaire.ResultsNo significant differences were identified between the groups regarding demographic data, such as age, gender, or body mass index. The median RSI score before operation and at 24-month follow-up was 22.8 ± 5.3 and 10.4 ± 5.4 respectively in the laparoscopic Nissen fundoplication (LNF) group (p < 0.05) and 21.7 ± 5.0 and 11.6 ± 5 respectively in the laparoscopic Toupet fundoplication (LTF) group (p < 0.05). The median LPR–HRQL score in the LNF group improved from 42.9 ± 13.8 before treatment to 10.7 ± 6.5 at 24 months (p < 0.05). In the LTF group, there was an improvement in the median LPR–HRQL score from 40.4 ± 10.9 prior to treatment to 11.7 ± 5.7 at 24 months (p < 0.05). The median RSI score and LPR–HRQL scores were similar between the groups at follow-up (p > 0.05).ConclusionsOur report demonstrates that LNF and LTF provide equivalently good results for patients with extraesophageal manifestations of GERD. Quality of life is similar after LNF and LTF.

Background Intracorporeal suturing is one of the most difficult laparoscopic tasks. The purpose of this study was to assess the impact of robotic assistance on novice suturing performance, safety, and workload in the operating room. Methods Medical students ( n  = 34), without prior laparoscopic suturing experience, were enrolled in an Institutional Review Board-approved, randomized protocol. After viewing an instructional video, subjects were tested in intracorporeal suturing on two identical, live, porcine Nissen fundoplication models; they placed three gastro-gastric sutures using conventional laparoscopic instruments in one model and using robotic assistance (da Vinci ® ) in the other, in random order. Each knot was objectively scored based on time, accuracy, and security. Injuries to surrounding structures were recorded. Workload was assessed using the validated National Aeronautics and Space Administration (NASA) task load index (TLX) questionnaire, which measures the subjects’ self-reported performance, effort, frustration, and mental, physical, and temporal demands of the task. Analysis was by paired t -test; p  < 0.05 was considered significant. Results Compared with laparoscopy, robotic assistance enabled subjects to suture faster (595 ± 22 s versus 459 ± 137 s, respectively; p  < 0.001), achieve higher overall scores (0 ± 1 versus 95 ± 128, respectively; p  < 0.001), and commit fewer errors per knot (1.15 ± 1.35 versus 0.05 ± 0.26, respectively; p  < 0.001). Subjects’ overall score did not improve between the first and third attempt for laparoscopic suturing (0 ± 0 versus 0 ± 0; p  = NS) but improved significantly for robotic suturing (49 ± 100 versus 141 ± 152; p  < 0.001). Moreover, subjects indicated on the NASA-TLX scale that the task was more difficult to perform with laparoscopic instruments compared with robotic assistance (99 ± 15 versus 57 ± 23; p  < 0.001). Conclusions Compared with standard laparoscopy, robotic assistance significantly improved intracorporeal suturing performance and safety of novices in the operating room while decreasing their workload. Moreover, the robot significantly shortened the learning curve of this difficult task. Further study is needed to assess the value of robotic assistance for experienced surgeons, and validated robotic training curricula need to be developed.

Transoral incisionless fundoplication (TIF) was developed in an attempt to create a minimally invasive endoscopic procedure that mimics antireflux surgery. The objective of this trial was to evaluate effectiveness of TIF compared with proton pump inhibition in a population consisting of gastroesophageal reflux disease (GERD) patients controlled with proton pump inhibitors (PPIs) who opted for an endoscopic intervention over lifelong drug dependence. Patients with chronic GERD were randomized (2:1) for TIF or continuation of PPI therapy. American Society of Anesthesiologists >2, body mass index >35 kg/m(2), hiatal hernia >2 cm, and esophageal motility disorders were exclusion criteria. Primary outcome measure was GERD-related quality of life. Secondary outcome measures were esophageal acid exposure, number of reflux episodes, PPI usage, appearance of the gastroesophageal valve, and healing of reflux esophagitis. Crossover for the PPI group was allowed after 6 months. A total of 60 patients (TIF n=40, PPI n=20, mean body mass index 26 kg/m(2), 37 male) were included. At 6 months, GERD symptoms were more improved in the TIF group compared with the PPI group (P<0.001), with a similar improvement of distal esophageal acid exposure (P=0.228) compared with baseline. The pH normalization for TIF group and PPI group was 50% and 63%, respectively. All patients allocated for PPI treatment opted for crossover. At 12 months, quality of life remained improved after TIF compared with baseline (P<0.05), but no improvement in esophageal acid exposure compared with baseline was found (P=0.171) and normalization of pH was accomplished in only 29% in conjunction with deteriorated valve appearances at endoscopy and resumption of PPIs in 61%. Although TIF resulted in an improved GERD-related quality of life and produced a short-term improvement of the antireflux barrier in a selected group of GERD patients, no long-term objective reflux control was achieved.

Purpose The aim of this work is to demonstrate a new concept of the surgical technique “FundoRing” for the prevention of acid and bile reflux esophagitis after gastric bypass. Materials and Methods A laparoscopic surgical technique of gastric bypass simultaneous with combined upper total and lower left partial fundoplication. This described case is a participant in an ongoing randomized clinical trial. Results The patient was without complications and was discharged on the third postoperative day. Delta BMI was 14 kg/m 2 (38–24) at the 1-year follow-up. The patient did not have heartburn or bile reflux esophagitis after surgery. Evaluation of the mucosa of the esophagus by upper endoscopy after each of the 3 follow-up visits demonstrated that reflux esophagitis had resolved. Intraoperative fluorescence imaging technologies (NIR/ICG) (IMAGE1 S™ Rubina®) were to determine the quality of blood supply—no violation of the blood supply to the fundoplication wrap of the gastric pouch was detected. A CT scan clearly shows a fundoplication ring around the esophagus (two-thirds) and the upper part of the gastric pouch (one-third). Conclusion The surgical technique of primary modified fundoplication using the excluded stomach with simultaneous gastric bypass is feasible.

Achalasia is a chronic, progressive, and incurable esophageal motility disease. There is clinical uncertainty about which treatment should be recommended as first-line therapy. Our objective was to evaluate the effectiveness of pneumatic dilation compared with laparoscopic Heller myotomy with partial fundoplication in improving achalasia-specific quality of life. This was a prospective, multicenter, randomized trial at five academic hospitals in Canada. Fifty previously untreated adults with a clinical diagnosis of primary achalasia, confirmed by manometric testing, were enrolled between November 2005 and March 2010, and followed for 5 years after treatment. Randomization was stratified by site, in random blocks of size four and with balanced allocation. Patients were treated with pneumatic dilation or laparoscopic Heller myotomy with partial fundoplication. The primary outcome was the difference between the treatments in the mean improvement of the achalasia severity questionnaire (ASQ) score at 1 year from baseline. Prespecified secondary outcomes included general and gastrointestinal quality of life, symptoms, esophageal physiology measures (lower esophageal sphincter relaxation and pressure, esophageal emptying, abnormal esophageal acid exposure), complications, and incidence of retreatment. Functional and imaging studies were performed blinded and all outcome assessors were blinded. There were no significant differences between treatments in the improvement of ASQ score at 1 year from baseline (27.5 points in the Heller myotomy arm vs. 20.2 points in the pneumatic dilation arm; difference 7.3 points, 95% confidence interval -4.7 to 19.3; P=0.23). There were no differences between treatments in improvement of symptoms, general and gastrointestinal quality of life, or measures of esophageal physiology. Improvements in ASQ score diminished over time for both interventions. At 5 years, there were no differences between treatments in improvement of ASQ score, symptoms, and general or gastrointestinal quality of life. There were no serious adverse events. No patient who received Heller myotomy required retreatment, whereas five patients treated initially with pneumatic dilation required retreatment. Treatment with pneumatic dilation or laparoscopic Heller myotomy similarly improves achalasia-specific disease severity at 1 year. Either of the therapeutic approaches can be used as first-line therapy for previously untreated adults with achalasia.

Background and Objectives: Obesity and gastroesophageal reflux disease (GERD) are steadily increasing world weight and antireflux surgery must be performed simultaneously with bariatric surgery in obese patients. The purpose of this study is to compare bariatric and antireflux results after OAGB with different methods of fundoplication using the excluded stomach and without fundoplication. Materials and methods: This open-label, randomized, parallel three-arm trial was conducted from March 2019 and December 2021. All patients underwent laparoscopic one-anastomosis gastric bypass and suture cruroplasty, and then had a follow-up at 24 months. Group 1 of patients had fundoplication FundoRing using the excluded stomach (FundoRingOAGB); Group 2, with Nissen fundoplication using the excluded stomach (NissenOAGB); and Group 3, without fundoplication (OAGB). We studied changes in BMI, GERD symptoms (GERD-HRQL), and the VISICK score. Results: Of 219 participants screened, 150 were randomly allocated to 3 groups: FundoRingOAGB group (n = 50), NissenOAGB group (n = 50), and OAGB group (n = 50). At post-treatment month 24, BMI changes were as follows: from 40.7 ± 5.9 (31–53) to 24.3 ± 2.8 (19–29) kg/m2 in FundoRingOAGB group; from 39.9 ± 5.3 (32–54) to 26.3 ± 2.9 (23–32) kg/m2 in Nissen group; and from 40.9 ± 6.2 (32–56) to 28.5 ± 3.9 (25–34) kg/m2 in OAGB group. The mean pre-operative GERD-HRQL heartburn score improved post-op in FundoRingOAGB group from 20.6 ± 2.24 (19.96, 21.23) to 0.44 ± 0.73 (0.23, 0,64); in NissenOAGB group from 21.34 ± 2.43 (20.64, 22.03) to 1.14 ± 1.4 (0.74, 1.53); and in OAGB group 20.5 ± 2.17 (19.9, 21.25) to 2.12 ± 1.36 (1.73, 2.5). GERD-HRQL total scores were from pre-op 25.2 ± 2.7 (24.4, 25.9) to 4.34 ± 1.3 (3.96, 4.7) post-op in FundoRingOAGB group; 24.8 ± 2.93 (24, 25.67) pre-op to 5.42 ± 1.7 (4.9, 5.9) in the NissenOAGB group; and from 21.46 ± 2.7 (20.7, 22.2) to 7.44 ± 2.7 (6.6, 8.2) in the OAGB group. The mean VISICK score improved from 3.64 ± 0.94 (3.7, 3.9) to 1.48 ± 1.26 (1.12, 1.84) in FundoRingOAGB, from 3.42 ± 0.97 (3.1, 3,7) to 2.5 ± 1.46 (2.06, 2.9) in NissenOAGB group and from 3.38 ± 0.88 (3.1, 3,69) to 2.96 ± 1.19 (2.62, 3.2) in OAGB group. Conclusions: Antireflux and bariatric results of FundoRingOAGB are better than using the NissenOAGB method and significantly better than OAGB without the use of fundoplication.