scholarly journals RefluxStopTM, a novel device to address gastroesophageal reflux disease: Short-term results

2021 ◽  
Vol 108 (Supplement_4) ◽  
Author(s):  
G A Prevost ◽  
C Di Pietro Martinelli ◽  
D Candinas ◽  
Y Borbély
Keyword(s):  
Gastroesophageal Reflux Disease ◽  
Gastroesophageal Reflux ◽  
Reflux Disease ◽  
Open Surgery ◽  
Long Term Results ◽  
Toupet Fundoplication ◽  
Short Term ◽  
Hrql Score ◽  
Conversion To Open Surgery

Abstract Objective To report safety, feasibility, and patient’s functional short-term outcome of novel RefluxStop anti reflux operation. Methods All patients (n = 20) who received laparoscopic implantation of the RefluxStop device from September 2018 to November 2020 in a university hospital were included for retrospective analysis. Incidence of adverse device-effects and procedure-related adverse events are reported as safety endpoints. Feasibility was assessed reporting operation duration, rate of conversion to open surgery and technically correct position of the device by control radiography during patient’s follow up. Subjective (Gastroesophageal Reflux Disease - Health Related Quality of Life (GERD-HRQL) - questionnaires; after 6 weeks and every six-month thereof) and objective data (24h-pH-manometry, barium swallows and upper endoscopies) are reported as functional outcome parameters. Comparison between values at baseline versus post-procedure follow-up are performed using the paired samples T-test, if appropriate. Results Median follow up was 4 (1 – 22) month. Three out of 20 patients had previous upper gastrointestinal surgery (EndoStim implantation). No serious adverse device related events occurred. One patient with dysphagia required balloon dilatation at the oesophageal gastric junction 4 weeks postoperatively. Median duration of surgery was 85 (59-188) minutes. There was no conversion to open surgery. There was significant reduction in the mean of total GERD-HRQL score at baseline compared to 6-weeks after surgery with 23.9 and 4.3 (p < 0.001) as well as at baseline and 6 month after surgery with 28.4 and 6.8 (p = 0.021), respectively. At 6 weeks follow up, all of the subjects had over 50% improvement of the GERD-HRQL score compared to baseline. One patient with acceptable device positioning developed symptom recurrence and received conversion to laparoscopic Toupet fundoplication after 10 months. Conclusion RefluxStop procedure seems to be a safe operation with promising short-term results. For high-level recommendation, further studies looking for long-term results and randomized comparisons to the standard anti reflux procedures like Nissen or Toupet fundoplication are required.

scholarly journals THE EFFICACY OF THE DIFFERENT ENDOSCOPIC TREATMENTS VERSUS SHAM, PHARMACOLOGIC OR SURGICAL METHODS FOR CHRONIC GASTROESOPHAGEAL REFLUX DISEASE: A SYSTEMATIC REVIEW AND META-ANALYSIS

2018 ◽  
Vol 55 (3) ◽  
pp. 296-305 ◽  
Author(s):  
Martin Andrés CORONEL ◽  
Wanderley Marques BERNARDO ◽  
Diogo Turiani Hourneaux de MOURA ◽  
Eduardo Turiani Hourneaux de MOURA ◽  
Igor Braga RIBEIRO ◽  
...  
Keyword(s):  
Systematic Review ◽  
Surgical Treatment ◽  
Gastroesophageal Reflux Disease ◽  
Gastroesophageal Reflux ◽  
Reflux Disease ◽  
Meta Analysis ◽  
Short Term ◽  
Significant Difference ◽  
Objective Outcomes

ABSTRACT BACKGROUND: Endoscopic antireflux treatments for gastroesophageal reflux disease (GERD) are still evolving, and most of the published studies address symptom relief in the short-term. Objective - We aimed to perform a systematic review and meta-analysis focused on evaluating the efficacy of the different endoscopic procedures. METHODS: Search was restricted to randomized controlled trials (RCTs) on MedLine, Cochrane, SciELO, and EMBASE for patients with chronic GERD (>6 months), over 18 years old and available follow up of at least 3 months. The main outcome was to evaluate the efficacy of the different endoscopic treatments compared to sham, pharmacological or surgical treatment. Efficacy was measured by different subjective and objective outcomes. RESULTS: We analyzed data from 16 RCT, totaling 1085 patients. The efficacy of endoscopic treatments compared to sham and proton pump inhibitors (PPIs) treatment showed a significant difference up to 6 months in favor of endoscopy with no heterogeneity (P<0.00001) (I2: 0%). The subgroup analysis showed a statistically significant difference up to 6 months in favor of endoscopy: endoscopy vs PPI (P<0.00001) (I2: 39%). Endoscopy vs sham (P<0.00001) (I2: 0%). Most subjective and objective outcomes were statistically significant in favor of endoscopy up to 6 and 12 months follow up. CONCLUSION: This systematic review and meta-analysis shows a good short-term efficacy in favor of endoscopic procedures when comparing them to a sham and pharmacological or surgical treatment. Data on long-term follow up is lacking and this should be explored in future studies.

Clinical Outcome at Ten Years after Laparoscopic Fundoplication: Nissen versus Toupet

2010 ◽  
Vol 76 (12) ◽  
pp. 1408-1411 ◽  
Author(s):  
Jaime Ruiz-Tovar ◽  
Maria Diez-Tabernilla ◽  
Alejandro Chames ◽  
Vicente Morales ◽  
Alfonso Sanjuanbenito ◽  
...  
Keyword(s):  
Surgical Treatment ◽  
Gastroesophageal Reflux Disease ◽  
Gastroesophageal Reflux ◽  
Reflux Disease ◽  
Laparoscopic Fundoplication ◽  
Surgical Techniques ◽  
Outcome Data ◽  
Long Term Results ◽  
Toupet Fundoplication

Laparoscopic surgery has become the elective approach for the surgical treatment of gastroesophageal reflux disease in the last decade. Outcome data beyond 10 years are available for open fundoplication, with good-to-excellent results, but few studies report long-term follow-up after laparoscopic fundoplication. We performed a retrospective study of all the patients that underwent laparoscopic Nissen and Toupet fundoplications as antireflux surgery between 1995 and 1998 in our institution. To evaluate the long-term results, a face-to-face interview was performed in 2009. One hundred and six patients were included in the study. Surgical techniques performed were Nissen fundoplication (NF) in 56 patients and Toupet (TF) in 50. Complication rate was 4 per cent in both groups (nonsignificant [NS]). Two patients (4%) of NF required reoperation because of dysphagia. After 10 years, 10 per cent of the patients remain symptomatic in both groups. Fifteen per cent of NF take daily inhibitors of the proton pump versus 14 per cent of TF (NS). Twenty per cent of NF refer dysphagia, all of them without evidence of stenosis at endoscopy or contrasted studies. The satisfaction rate of the patients was 96 per cent in NF and 98 per cent in TF. Laparoscopic Toupet fundoplication seems to be as safe and long-term effective as Nissen, but with a lower incidence of postoperative dysphagia. In our experience Toupet fundoplication should be the elective approach for the surgical treatment of gastroesophageal reflux disease.

scholarly journals A novel surgical approach for treating hiatal hernia with gastroesophageal reflux disease: the laparoscopic total left-side surgical approach

2021 ◽  
Author(s):  
Zhi Zheng ◽  
Xiaoye Xiaoye Liu ◽  
Chenglin Xin ◽  
Weitao Zhang ◽  
Yan Gao ◽  
...  
Keyword(s):  
Gastroesophageal Reflux Disease ◽  
Gastroesophageal Reflux ◽  
Vagus Nerve ◽  
Hiatal Hernia ◽  
Surgical Approach ◽  
Reflux Disease ◽  
Cadaver Study ◽  
Long Term Results ◽  
Perioperative Outcomes

Abstract BackgroundAlthough the traditional bilateral surgical approach can provide local protection of the vagus nerve, the integrity of the entire vagus nerve cannot be evaluated. Therefore, we developed total left-side surgical approach (TLSA), which theoretically eliminates injury to the vagus nerve, and evaluated its safety and effectiveness.MethodsWe initially performed a cadaver study to explore the characteristics of the vagus nerve, and then prospectively evaluated the TLSA in 5 patients with hiatal hernia and gastroesophageal reflux disease between June 2020 and September 2020. Demographic characteristics, surgical parameters, perioperative outcomes, and follow-up findings were analyzed.ResultsThe patients were 40–64 years old and all 5 patients underwent TLSA successfully without any major complications. The median total operative time was 114 min, the median blood loss was 50 mL, and the median postoperative hospital stay was 3.8 days. Gastrointestinal function recovered within 4 days in all patients. The 6-month follow-up gastroscopy examination revealed well-established gastroesophageal flap valves. Relative to the baseline results, the 6-month follow-up revealed lower values for the total GerdQ score (12.4 vs. 6.2) and the total esophageal acid exposure time (3.48% vs. 0.38%). Based on the EORTC QLQ-STO52 questionnaire results, the incidences of dysphagia and flatulence decreased over time after the procedure.ConclusionsTLSA provides a clear and broad surgical field, less trauma, rapid recovery, and is technically simple. Although our results suggest that the TLSA provides good safety and short-term efficacy, long-term results from a larger clinical trial are needed to validate these findings.Trial registrationChiCTR2000034028, registration date is June 21, 2020.

scholarly journals Hiatal hernia repair with Toupet fundoplication in surgical treatment of hiatal hernia, complicated by gastroesophageal reflux disease

2019 ◽  
Vol 10 (3) ◽  
pp. 5-12
Author(s):  
A. G. Grintcov ◽  
R. V. Ishenko ◽  
Igor V. Sovpel ◽  
O. V. Sovpel ◽  
Ju. A. Shapovalova
Keyword(s):  
Surgical Treatment ◽  
Gastroesophageal Reflux Disease ◽  
Gastroesophageal Reflux ◽  
Hernia Repair ◽  
Hiatal Hernia ◽  
Reflux Disease ◽  
Hiatal Hernia Repair ◽  
Toupet Fundoplication ◽  
Short Term

Introduction. Hiatal hernia occupies a third place in the structure of the gastrointestinal tract pathology. The association of hiatal hernia with gastroesophageal reflux disease can lead to severe complications and requires a surgical treatment. Objective. To analyze short-term and long-term results of a surgical treatment of patients with hiatal hernia complicated by gastroesophageal reflux disease (GERD). Methods. A retrospective analysis of the short-term and long-term treatment results of 62 patients suffering from hiatal hernia complicated by gastroesophageal reflux disease was performed. All the patients underwent a laparoscopic hiatal hernia repair supplemented by Toupet fundoplication. Results. The hospital stay duration was 7.21.6 days. The postoperative complication rate was 6.5%. Mild functional dysphagia was noted in 8(12.9%). Persistent long-term dysphagia in the late postoperative period was observed in 2(3.2%) patients. The recurrences of hiatal hernia or GERD were noted in 15(24.2%) patients in 5 years after the surgery. The total GERD-HRQL questionnaire score 5 years after the surgery was 5.73.9. Сonclusion. Laparoscopic interventions are safe, less traumatic, provide the possibility of early rehabilitation of patients, can achieve positive functional results in 85% of patients and should be used in the treatment of patients suffering from hiatal hernia complicated by GERD.

scholarly journals A new technique for treating hiatal hernia with gastroesophageal reflux disease: the laparoscopic total left-side surgical approach

BMC Surgery ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Zhi Zheng ◽  
Xiaoye Liu ◽  
Chenglin Xin ◽  
Weitao Zhang ◽  
Yan Gao ◽  
...  
Keyword(s):  
Gastroesophageal Reflux Disease ◽  
Gastroesophageal Reflux ◽  
Vagus Nerve ◽  
Hiatal Hernia ◽  
Surgical Approach ◽  
Reflux Disease ◽  
Long Term Results ◽  
Perioperative Outcomes ◽  
Life Questionnaire

Abstract Introduction Although the traditional bilateral surgical approach to treat hiatal hernia (HH) with gastroesophageal reflux disease (GERD) can provide local protection of the vagus nerve, the integrity of the entire vagus nerve cannot be evaluated. Therefore, we developed and described the total left-side surgical approach (TLSA), which theoretically reduces injury to the vagus nerve, and described the detailed surgical procedure. Methods Initially, we performed a cadaver study to explore the characteristics of the vagus nerve. Then, we prospectively evaluated the TLSA in 5 patients with HH and GERD between June 2020 and September 2020. Demographic characteristics, surgical parameters, perioperative outcomes, and follow-up findings were analyzed. Results The TLSA was successfully used in five patients (40–64 years old), and no major complications were noted. The median total operative time was 114 min, median blood loss was 50 mL, and median postoperative hospital stay was 3.8 days. Gastrointestinal function recovered within 4 days of surgery in all the patients. The 6-month follow-up gastroscopy examination showed well-established gastroesophageal flap valves. Compared with the baseline results, the 6-month follow-up results showed lower values for the total GerdQ score (12.4 vs. 6.2) and the total esophageal acid exposure time (3.48% vs. 0.38%). Based on the European Organization for Research and Treatment of Cancer quality of life questionnaire-stomach module 52 results, the incidence of dysphagia and flatulence decreased over time after the TLSA. Conclusions The TLSA provides a clear and broad surgical field, less trauma, and rapid recovery; moreover, it is technically simple. Although our results suggest that the TLSA provides safety and short-term efficacy and is feasible for patients with HH and GERD, long-term results from a larger clinical trial are needed to validate these findings. Trial registration ChiCTR2000034028, registration date is June 21, 2020. The study was registered prospectively

scholarly journals Surgical treatment of recalcitrant gastroesophageal reflux disease in patients with systemic sclerosis: a systematic review

2021 ◽  
Author(s):  
Alberto Aiolfi ◽  
Mario Nosotti ◽  
Kazuhide Matsushima ◽  
Carolina Perali ◽  
Cristina Ogliari ◽  
...  
Keyword(s):  
Systematic Review ◽  
Systemic Sclerosis ◽  
Surgical Treatment ◽  
Gastroesophageal Reflux Disease ◽  
Gastroesophageal Reflux ◽  
Reflux Disease ◽  
Current Data ◽  
Current Evidence ◽  
Increased Risk

Abstract Introduction Gastroesophageal reflux disease (GERD) is frequently seen in patients with systemic sclerosis (SSc). Long-standing GERD may cause esophagitis, long-segment strictures, and Barrett’s esophagus and may worsen pre-existing pulmonary fibrosis with an increased risk of end-stage lung disease. Surgical treatment of recalcitrant GERD remains controversial. The purpose of this systematic review was to summarize the current data on surgical treatment of recalcitrant GERD in SSc patients. Materials and methods A systematic literature review according to PRISMA and MOOSE guidelines. PubMed, EMBASE, and Web of Science databases were consulted. Results A total of 101 patients were included from 7 studies. The age ranged from 34 to 61 years and the majority were females (73.5%). Commonly reported symptoms were heartburn (92%), regurgitation (77%), and dysphagia (74%). Concurrent pulmonary disease was diagnosed in 58% of patients. Overall, 63 patients (62.4%) underwent open fundoplication, 17 (16.8%) laparoscopic fundoplication, 15 (14.9%) Roux en-Y gastric bypass (RYGB), and 6 (5.9%) esophagectomy. The postoperative follow-up ranged from 12 to 65 months. Recurrent symptoms were described in up to 70% and 30% of patients undergoing fundoplication and RYGB, respectively. Various symptoms were reported postoperatively depending on the type of surgical procedures, anatomy of the valve, need for esophageal lengthening, and follow-up. Conclusions The treatment of recalcitrant GERD in SSc patients is challenging. Esophagectomy should be reserved to selected patients. Minimally invasive RYGB appears feasible and safe with promising preliminary short-term results. Current evidence is scarce while a definitive indication about the most appropriate surgical treatment is lacking.

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