Transoral incisionless fundoplication for recurrent symptoms after laparoscopic fundoplication.

BACKGROUND: Revision of a failed laparoscopic fundoplication carries higher risk of complication and lower chance of success compared to the original surgery. Transoral incisionless fundoplication (TIF) may be an endoscopic alternative for select GERD patients without need of a moderate/large hiatal hernia repair. The aim of this study was to assess feasibility, efficacy, and safety of TIF 2.0 after failed laparoscopic Nissen or Toupet fundoplication (TIFFF). METHODS: This is a multicenter retrospective cohort study of patients who underwent TIFFF between September 2017 and December 2020 using TIF 2.0 technique (EsophyX Z/Z+) performed by gastroenterologists and surgeons. Patients were included if they had (1) recurrent GERD symptoms, (2) pathologic reflux based upon pH testing or Grade C/D esophagitis or Barrett's esophagus, and (3) hiatal hernia ≤ 2 cm. The primary outcome was improvement in GERD Health-Related Quality of Life (GERD-HRQL) post-TIFFF. The TIFFF cohort was also compared to a similar surgical re-operative cohort using propensity score matching. RESULTS: Twenty patients underwent TIFFF (median 4.1 years after prior fundoplication) and mean GERD-HRQL score improved from 24.3 ± 22.9 to 14.75 ± 21.6 (p = 0.014); mean Reflux Severity Index (RSI) score improved from 14.1 ± 14.6 to 9.1 ± 8.0 (p = 0.046) with 8/10 (80%) of patients with normal RSI (< 13) post-TIF. Esophagitis healed in 78% of patients. PPI use decreased from 85 to 55% with 8/20 (45%) patients off of PPI. Importantly, mean acid exposure time decreased from 12% ± 17.8 to 0.8% ± 1.1 (p = 0.028) with 9/9 (100%) of patients with normalized pH post-TIF. There were no statistically significant differences in clinical efficacy outcomes between TIFFF and surgical revision, but TIFFF had significantly fewer late adverse events. CONCLUSION: Endoscopic rescue with TIF is a safe and efficacious alternative to redo laparoscopic surgery in symptomatic patients with appropriate anatomy and objective evidence of persistent or recurrent reflux.

Response of Laryngopharyngeal Symptoms to Transoral Incisionless Fundoplication in Patients with Refractory Proven Gastroesophageal Reflux.

OBJECTIVE: Patients with laryngopharyngeal reflux (LPR) symptoms may not respond to proton pump inhibitors (PPI) if they have an alternative laryngeal diagnosis or high-volume reflux. Transoral incisionless fundoplication (TIF) or TIF with concomitant hiatal hernia repair (cTIF) are effective in decreasing symptoms of gastroesophageal reflux disease (GERD) but are not well studied in patients with LPR symptoms. This prospective multicenter study assessed the patient-reported and clinical outcomes after TIF/cTIF in patients with LPR symptoms and proven GERD. METHODS: Patients with refractory LPR symptoms (reflux symptom index [RSI] > 13) and with erosive esophagitis, Barrett's esophagus, and/or pathologic acid reflux by distal esophageal pH testing were evaluated before and after a minimum of 6 months after TIF/cTIF. The primary outcome was normalization of RSI. Secondary outcomes were >50% improvement in GERD-Health-Related Quality of Life (GERD-HRQL), normalization of esophageal acid exposure time, discontinuation of PPI, and patient satisfaction. RESULTS: Forty-nine patients had TIF (n = 26) or cTIF (n = 23) with at least 6 months follow-up. Mean pre- and post TIF/cTIF RSI were 23.6 and 5.9 (mean difference: 17.7, P < .001). Post TIF/cTIF, 90% of patients had improved GERD-HQRL score, 85% normalized RSI, 75% normalized esophageal acid exposure time, and 80% discontinued PPI. No serious procedure-related adverse events occurred. Patient satisfaction was 4% prior to TIF/cTIF and 73% after TIF/cTIF (P < .001). CONCLUSION: In patients with objective evidence of GERD, TIF, or cTIF are safe and effective in controlling LPR symptoms as measured by normalization of RSI and improvement in patient satisfaction after TIF/cTIF. LEVEL OF EVIDENCE: Level 4.

Angle of His Accentuation Is a Viable Alternative to Dor Fundoplication as an Adjunct to Laparoscopic Heller Cardiomyotomy: Results of a Randomized Clinical Study.

BACKGROUND: There is no consensus regarding the type of anti-reflux procedure to be used as an adjunct to laparoscopic Heller cardiomyotomy (LHCM). The aim of this study was to compare Angle of His accentuation (AOH) with Dor Fundoplication (Dor) as an adjunct to LHCM. METHODS: A total of 110 patients with achalasia cardia presenting for LHCM from March 2010 to July 2015 were randomized to Dor and AOH. Symptom severity, achalasia-specific quality of life (ASQOL), new onset heartburn, and patient satisfaction were assessed using standardized scores preoperatively, at 3, 6 months, and then yearly. The primary outcome was relief of esophageal symptoms while secondary outcomes were new onset heartburn and ASQOL. RESULTS: Both groups were comparable with respect to the baseline demographic characteristics. There was no conversion to open and no mortality in either group. Median operative time was 128 min in AOH and 144 min in Dor group (p < 0.01). Mean follow-up was 36 months and was available in 98% patients. There was significant improvement in esophageal symptoms in both groups with no statistically significant difference between the two groups (p > 0.05). There was no difference in cumulative symptom scores between the two groups over the period of follow-up. New onset heartburn was seen in 11% in AOH and 9% in Dor group. Mean ASQOL score improved in both groups with no difference between the two groups (p = 0.83). Patient satisfaction was similar in both groups. CONCLUSION: AOH is similar to Dor as an adjunct to LHCM in safety and efficacy and can be performed in shorter time. CLINICAL REGISTRATION NUMBER: CTRI: REF/2014/06/007146.

Esophageal achalasia: current diagnosis and treatment.

INTRODUCTION: Esophageal achalasia is a primary esophageal motility disorder of unknown origin, characterized by lack of peristalsis and by incomplete or absent relaxation of the lower esophageal sphincter in response to swallowing. The goal of treatment is to eliminate the functional obstruction at the level of the gastroesophageal junction. Areas covered: This comprehensive review will evaluate the current literature, illustrating the diagnostic evaluation and providing an evidence-based treatment algorithm for this disease. Expert commentary: Today, we have three very effective therapeutic modalities to treat patients with achalasia - pneumatic dilatation, peroral endoscopic myotomy, and laparoscopic Heller myotomy with fundoplication. Treatment should be tailored to the individual patient, in centers where a multidisciplinary approach is available. Esophageal resection should be considered as a last resort for patients who have failed prior therapeutic attempts.

Management of failure after surgery for gastro-esophageal reflux disease.

Surgical treatment of gastro-esophageal reflux disease (ST-GERD) is well-codified and offers an alternative to long-term medical treatment with a better efficacy for short and long-term outcomes. However, failure of ST-GERD is observed in 2-20% of patients; management is challenging and not standardized. The aim of this study is to analyze the causes of failure and to provide a treatment algorithm. The clinical aspects of ST-GERD failure are variable including persistent reflux, dysphagia or permanent discomfort leading to an important degradation of the quality of life. A morphological and functional pre-therapeutic evaluation is necessary to: (i) determine whether the symptoms are due to recurrence of reflux or to an error in initial indication and (ii) to understand the cause of the failure. The most frequent causes of failure of ST-GERD include errors in the initial indication, which often only need medical treatment, and surgical technical errors, for which surgical redo surgery can be difficult. Multidisciplinary management is necessary in order to offer the best-adapted treatment.

Efficacy of Laparoscopic Nissen Fundoplication vs Transoral Incisionless Fundoplication or Proton Pump Inhibitors in Patients With Gastroesophageal Reflux Disease: A Systematic Review and Network Meta-analysis.

BACKGROUND & AIMS: The effects of transoral incisionless fundoplication (TIF) and laparoscopic Nissen fundoplication (LNF) have been compared with those of proton pump inhibitors (PPIs) or a sham procedure in patients with gastroesophageal reflux disease (GERD), but there has been no direct comparison of TIF vs LNF. We performed a systematic review and network meta-analysis of randomized controlled trials to compare the relative efficacies of TIF vs LNF in patients with GERD. METHODS: We searched publication databases and conference abstracts through May 10, 2017 for randomized controlled trials that compared the efficacy of TIF or LNF with that of a sham procedure or PPIs in patients with GERD. We performed a network meta-analysis using Bayesian methods under random-effects multiple treatment comparisons. We assessed ranking probability by surface under the cumulative ranking curve. RESULTS: Our search identified 7 trials comprising 1128 patients. Surface under the cumulative ranking curve ranking indicated TIF had highest probability of increasing patients' health-related quality of life (0.96), followed by LNF (0.66), a sham procedure (0.35), and PPIs (0.042). LNF had the highest probability of increasing percent time at pH <4 (0.99), followed by PPIs (0.64), TIF (0.32), and the sham procedure (0.05). LNF also had the highest probability of increasing LES pressure (0.78), followed by TIF (0.72) and PPIs (0.01). Patients who underwent the sham procedure had the highest probability for persistent esophagitis (0.74), followed by those receiving TIF (0.69), LNF (0.38), and PPIs (0.19). Meta-regression showed a shorter follow-up time as a significant confounder for the outcome of health-related quality of life in studies of TIF. CONCLUSIONS: In a systematic review and network meta-analysis of trials of patients with GERD, we found LNF to have the greatest ability to improve physiologic parameters of GERD, including increased LES pressure and decreased percent time pH <4. Although TIF produced the largest increase in health-related quality of life, this could be due to the shorter follow-up time of patients treated with TIF vs LNF or PPIs. TIF is a minimally invasive endoscopic procedure, yet based on evaluation of benefits vs risks, we do not recommend it as a long-term alternative to PPI or LNF treatment of GERD.

Surgical Anti-Reflux Options Beyond Fundoplication.

PURPOSE OF REVIEW: This paper provides an overview of current and future surgical interventions available for the management of gastroesophageal reflux disease (GERD) beyond the well established and recognized fundoplication. Review the current indications and outcomes of these surgical procedures. RECENT FINDINGS: Fundoplication has been a cornerstone of the surgical management of GERD. However, other effective surgical options exist and can be considered based on prior interventions as well as patient, anatomical or other factors. These options are intended to address some of the shortcomings or potential complications of fundoplication such as symptom recurrence, dysphagia, or gas bloating, for example. Alternative procedures to fundoplication include magnetic sphincter augmentation, electrical stimulation and Roux-en-Y gastric bypass. The indication for surgical management remains failure of or inability to tolerate medical therapy.

New Approaches to Gastroesophageal Reflux Disease.

BACKGROUND: Gastroesophageal reflux disease (GERD) is the most common gastrointestinal disorder of the esophagus. It is a chronic, progressive disorder that presents most typically with heartburn and regurgitation and atypically with chest pain, dysphagia, chronic cough, globus, or sore throat. The mainstay for diagnosis and characterization of the disorder is esophagoduodenoscopy (EGD), high-resolution esophageal manometry, and symptom-associated ambulatory esophageal pH impedance monitoring. Additional studies that can be useful in certain clinical presentations include gastric scintigraphy and oral contrast upper gastrointestinal radiographic series. DISCUSSION: Refractory GERD can be surgically managed with various techniques. In obese individuals, laparoscopic Roux-en-Y gastric bypass should be considered due to significant symptom improvement and lower incidence of recurrent symptoms with weight loss. Otherwise, laparoscopic Nissen fundoplication is the preferred surgical technique for treatment of this disease with concomitant hiatal hernia repair when present for either procedure. The short-term risks associated with these procedures include esophageal or gastric injury, pneumothorax, wound infection, and dysphagia. Emerging techniques for treatment of this disease include the Linx Reflux Management System, EndoStim LES Stimulation System, Esophyx® and MUSE™ endoscopic fundoplication devices, and the Stretta endoscopic ablation system. Outcomes after surgical management of refractory GERD are highly dependent on adherence to strict surgical indications and appropriate patient-specific procedure selection.

Long-term and 'patient-reported' outcomes of total esophagogastric dissociation versus laparoscopic fundoplication for gastroesophageal reflux disease in the severely neurodisabled child.

AIM: Fundoplication has high failure rates in neurodisability: esophagogastric dissociation (TOGD) has been proposed as an alternative. This study aimed to compare the long-term and 'patient-reported' outcomes of TOGD and laparoscopic fundoplication (LapFundo). METHODS: Matched cohort comparison comprises (i) retrospective analysis from a prospective database and (ii) carer questionnaire survey of symptoms and quality of life (CP-QoL-Child). Children were included if they had severe neurodisability (Gross Motor Function Classification System five) and spasticity. RESULTS: Groups were similar in terms of previous surgery and comorbidities. The TOGD group was younger (22 vs. 31.5months, p=0.038) with more females (18/23 vs. 11/24, p=0.036). TOGD was more likely to require intensive care: operative time, length of stay and time to full feeds were all longer (p<0.0001). Median follow-up was 6.3 and 5.8years. Rates of complications were comparable. Symptom recurrence (5/24 vs. 1/23, p=0.34) and use of acid-reducing medication (13/24 vs. 4/23, p=0.035) were higher for LapFundo. Carer-reported symptoms and QoL were similar. CONCLUSIONS: TOGD had similar efficacy to LapFundo (with suggestion of lower failure), with comparable morbidity and carer-reported outcomes. However, TOGD was more 'invasive,' requiring longer periods of rehabilitation. Families should be offered both procedures as part of comprehensive preoperative counseling.

Minimal access surgery compared with medical management for gastro-oesophageal reflux disease: five year follow-up of a randomised controlled trial (REFLUX).

OBJECTIVES: To determine the long term clinical effectiveness of laparoscopic fundoplication as an alternative to drug treatment for chronic gastro-oesophageal reflux disease (GORD). DESIGN: Five year follow-up of multicentre, pragmatic randomised trial (with parallel non-randomised preference groups). SETTING: Initial recruitment in 21 UK hospitals. PARTICIPANTS: Responders to annual questionnaires among 810 original participants. At entry, all had had GORD for >12 months. INTERVENTION: The surgeon chose the type of fundoplication. Medical therapy was reviewed and optimised by a specialist. Subsequent management was at the discretion of the clinician responsible for care, usually in primary care. MAIN OUTCOME MEASURES: Primary outcome measure was self reported quality of life score on disease-specific REFLUX questionnaire. Other measures were health status (with SF-36 and EuroQol EQ-5D questionnaires), use of antireflux medication, and complications. RESULTS: By five years, 63% (112/178) of patients randomised to surgery and 13% (24/179) of those randomised to medical management had received a fundoplication (plus 85% (222/261) and 3% (6/192) of those who expressed a preference for surgery and for medical management). Among responders at 5 years, 44% (56/127) of those randomised to surgery were taking antireflux medication versus 82% (98/119) of those randomised to medical management. Differences in the REFLUX score significantly favoured the randomised surgery group (mean difference 8.5 (95% CI 3.9 to 13.1), P<0.001, at five years). SF-36 and EQ-5D scores also favoured surgery, but were not statistically significant at five years. After fundoplication, 3% (12/364) had surgical treatment for a complication and 4% (16) had subsequent reflux-related operations-most often revision of the wrap. Long term rates of dysphagia, flatulence, and inability to vomit were similar in the two randomised groups. CONCLUSIONS: After five years, laparoscopic fundoplication continued to provide better relief of GORD symptoms than medical management. Adverse effects of surgery were uncommon and generally observed soon after surgery. A small proportion had re-operations. There was no evidence of long term adverse symptoms caused by surgery. TRIAL REGISTRATION: Current Controlled Trials ISRCTN15517081.

Randomized clinical trial of the influence of intraperitoneal local anaesthesia on pain after laparoscopic surgery.

BACKGROUND: There is controversy about the effectiveness of intraperitoneal local anaesthesia (LA) in laparoscopic surgery. The aim of the present randomized clinical trial was to compare the analgesic effect of pre-emptive (preoperative) versus postoperative intraperitoneal LA in two different types of laparoscopic surgery. METHODS: Between July 2004 and January 2005, 133 consecutive patients scheduled to undergo laparoscopic fundoplication or hernia repair were randomly assigned to one of three treatments: placebo solution (50 ml 0.9 per cent saline) or LA (50 ml 0.5 per cent lidocaine) administered immediately after creation of the pneumoperitoneum, or LA (50 ml 0.5 per cent lidocaine) at the end of the operation. Analgesic requirements were analysed, and pain was assessed using a visual analogue scale (VAS) from 0 to 100 at 6, 12, 24 and 48 h after surgery. RESULTS: The duration of pneumoperitoneum (median 66 versus 46 min respectively; P < 0.001) and overall pain intensity (median VAS score 46.7 versus 6.5; P < 0.001) were higher for laparoscopic fundoplication than for hernia repair. Preoperative application of LA reduced abdominal pain (median 28.6 versus 74.9; P < 0.005), shoulder pain (median 24.3 versus 43.8; P = 0.004) and analgesic consumption (mean(s.d.) 11.1(5.0) versus 18.5(5.4) mg piritramide per 48 h; P = 0.002) after fundoplication, but had no analgesic effects after hernia repair. CONCLUSION: Pre-emptive application of LA reduced postoperative pain and analgesic requirements after laparoscopic fundoplication.

Acarbose treatment of postprandial hypoglycemia in children after Nissen fundoplication.

Dumping syndrome and postprandial hypoglycemia have been reported after Nissen fundoplication. The physiopathologic mechanisms are poorly understood and a variety of therapies have failed to control the hypoglycemia in these patients. We report a series of 6 infants with postprandial hypoglycemia after Nissen fundoplication who were treated successfully with acarbose.

Esophagogastric dissociation versus fundoplication: Which is best for severely neurologically impaired children?

PURPOSE: Neurologically impaired children (NIC) often have swallowing difficulties, severe gastroesophageal reflux, recurrent respiratory infections, and malnutrition. Bianchi proposed esophagogastric dissociation (EGD) as an alternative to fundoplication and gastrostomy. The authors compared these 2 approaches. METHODS: Twenty-nine consecutive symptomatic NIC refractory to medical therapy were enrolled in a prospective study and divided into 2 groups: A (n = 12), NIC who underwent fundoplication and gastrostomy; B (n = 14), NIC who underwent EGD. Three were excluded because of previous fundoplication. Anthropometric (percentage of the 50th percentile/age of healthy children) and biochemical parameters, respiratory infections per year, hospitalization (days per year), feeding time (minutes), and "quality of life" (parental psychological questionnaire, range 0 to 60), were analyzed (t test and Mann-Whitney test) preoperatively and 1 year postoperatively. Complications were recorded. RESULTS: Compared with group A, group B presented a statistically significant increase of all anthropometric and nearly all biochemical parameters with a statistical difference in terms of respiratory infections, hospital stay, feeding time, and psychological questionnaire. In group A, 2 bowel obstructions, 1 tight fundoplication, 1 dumping syndrome, and 3 failures of fundoplication occurred. Group B presented 1 anastomotic stricture, 1 paraesophageal hernia, and 1 bowel obstruction. CONCLUSIONS: Compared with fundoplication and gastrostomy, EGD offered better nutritional rehabilitation, reduction in respiratory infections, and improved quality of life. EGD can be rightfully chosen as a primary procedure.

Laparoscopic Nissen fundoplication is a satisfactory alternative to long-term omeprazole therapy.

A total of 168 patients with proven gastro-oesophageal reflux disease (GORD) receiving long-term medical therapy underwent laparoscopic Nissen fundoplication. The operation was converted to open fundoplication in four patients. All patients reported complete (92.3 per cent) or partial (7.7 per cent) relief of reflux symptoms 1 month after surgery. There were no associated deaths and the perioperative complication rate was 8.9 per cent. The mean(s.e.m.) length of operating time was 69.9(2.4) min and mean(s.e.m.) hospital stay 2.7(0.1) days. Symptom score assessment, 24-h oesophageal pH recording and lower oesophageal sphincter pressure showed significant (P < 0.0001) improvement 6 months after surgery in 85 evaluable patients. Before operation 37.5 per cent of the patients were considered symptomatically controlled on omeprazole and had excellent symptom control after surgery. This initial experience suggests that laparoscopic Nissen fundoplication is a safe and effective treatment for patients with GORD requiring long-term medication.