Long-term follow-up of two randomized trials comparing laparoscopic Nissen 360° with anterior 90° partial fundoplication.

BACKGROUND: The side-effects of Nissen fundoplication have led to modifications, including partial fundoplications such as an anterior 90° wrap. Five-year follow-up of two randomized trials suggested fewer side-effects following anterior 90° partial fundoplication, but better reflux control after Nissen fundoplication. However, longer-term outcomes have not been reported. This study combined data from previous trials to determine 10-year outcomes. METHODS: From 1999 to 2003, 191 patients were enrolled in two randomized trials comparing anterior 90° partial versus Nissen fundoplication. Trial protocols were similar, and data were combined to determine long-term clinical outcomes. Patients completed annual questionnaires assessing dysphagia, heartburn, medications, satisfaction and other symptoms. Visual analogue scales (0-10), a composite dysphagia score (0-45) and yes/no responses were used. RESULTS: Of the 191 patients, 152 (79·6 per cent) were available for 10-year follow-up. After anterior 90° fundoplication, patients reported less dysphagia to solids (score 2·03 versus 3·18 for the Nissen procedure; P = 0·037). Heartburn scores were lower after Nissen fundoplication (1·90 versus 2·83 for anterior 90° fundoplication; P = 0·035) and fewer patients required proton pump inhibitors (PPIs) (22 versus 39 per cent respectively; P = 0·035). Satisfaction scores were similar for both anterior 90° and Nissen groups (7·45 versus 7·36 respectively; P = 0·566), and the majority considered their original decision for surgery to be correct (86 versus 84 per cent; P = 0·818). CONCLUSION: After 10 years, both procedures achieved similar success as measured by global satisfaction measures. Patients who had a Nissen fundoplication reported more dysphagia, whereas more heartburn and PPI consumption were reported after anterior 90° fundoplication. Registration numbers: ACTRN12607000298415 and ACTRN12607000304437 (http://www.anzctr.org.au/).

ANTECEDENTES: Para evitar los efectos secundarios de la fundoplicatura de Nissen se han propuesto modificaciones técnicas, incluyendo las fundoplicaturas parciales como la plicatura anterior de 90°. El seguimiento a 5 años de dos ensayos aleatorizados sugiere menos efectos secundarios tras la fundoplicatura anterior de 90°, pero mejor control del reflujo con la fundoplicatura de Nissen. Sin embargo, no se han descrito los resultados a largo plazo. Este estudio combinó datos de dos ensayos previos para determinar los resultados a 10 años. MÉTODOS: Entre 1999 y 2003, se reclutaron 191 pacientes en dos ensayos aleatorizados que comparaban la fundoplicatura parcial anterior 90° versus fundoplicatura de Nissen. Los protocolos de ambos ensayos fueron similares, y los datos se combinaron para determinar los resultados clínicos a largo plazo. Los pacientes completaron cuestionarios anuales que evaluaban disfagia, pirosis, medicaciones, satisfacción y otros síntomas. Se utilizaron escalas analógicas visuales (0-10), una variable compuesta para la puntuación de disfagia (0-45) y respuestas sí/no. RESULTADOS: De los 191 pacientes, 152 (79,6%) pudieron seguirse a los 10 años. Tras la fundoplicatura anterior de 90°, los pacientes refirieron menos disfagia a sólidos (2,03 versus 3,18, P = 0,037). Las puntuaciones de pirosis fueron inferiores tras fundoplicatura de Nissen (2,83 versus 1,90, P = 0,035) y menos pacientes tomaban inhibidores de la bomba de protones (proton pump inhibitors, PPIs; 22% versus 39%, P = 0,035). Las puntuaciones de satisfacción fueron similares para ambos grupos de fundoplicatura anterior 90° y Nissen (7,45 versus 7,36, P = 0,566), y la mayoría consideró su decisión original para la cirugía como correcta (86,1% versus. 83,8%, P = 0,818). Las tasas de reoperación fueron similares (10,0% versus 8,8%). CONCLUSIÓN: Después de 10 años, ambos procedimientos lograron un éxito similar medido con medidas de satisfacción global. Los pacientes con fundoplicatura de Nissen referían más disfagia mientras que los pacientes con fundoplicatura anterior 900 describieron más pirosis y consumo de PPIs.

Acceptable outcomes after fundoplication-different views are held by patients, GPs, and surgeons.

Antireflux surgery aims to improve quality of life. However, whether patients and clinicians agree on what this means, and what is an acceptable outcome following fundoplication, is unknown. This study used clinical scenarios pertinent to laparoscopic fundoplication for gastroesophageal reflux to define acceptable outcomes from the perspective of patients, surgeons, and general practitioners (GPs). Patients who had previously undergone a laparoscopic fundoplication, general practitioners, and esophagogastric surgeons were invited to rank 11 clinical scenarios of outcomes following laparoscopic fundoplication for acceptability. Clinicopathological and practice variables were collated for patients and clinicians, respectively. GPs and esophagogastric surgeons additionally were asked to estimate postfundoplication outcome probabilities. Descriptive and multivariate statistical analyses were undertaken to examine for associations with acceptability. Reponses were received from 331 patients (36.4% response rate), 93 GPs (13.4% response), and 60 surgeons (36.4% response). Bloating and inability to belch was less acceptable and dysphagia requiring intervention more acceptable to patients compared to clinicians. On regression analysis, female patients found bloating to be less acceptable (OR: 0.51 [95%CI: 0.29-0.91]; P = 0.022), but dysphagia more acceptable (OR: 1.93 [95%CI: 1.17-3.21]; P = 0.011). Postfundoplication estimation of reflux resolution was higher and that of bloating was lower for GPs compared to esophagogastric surgeons. Patients and clinicians have different appreciations of an acceptable outcome following antireflux surgery. Female patients are more concerned about wind-related side effects than male patients. The opposite holds true for dysphagia. Surgeons and GPs differ in their estimation of event probability for patient recovery following antireflux surgery, and this might explain their differing considerations of acceptable outcomes.

Psychologic Distress and Anxiety in Mothers of Children With Gastroesophageal Reflux Undergoing Antireflux Surgery.

OBJECTIVES: Parents of children with a chronic illness are at risk for impaired psychosocial functioning. Gastroesophageal reflux disease (GERD) is such a disease, and no studies have investigated effects of antireflux surgery on parental psychological distress. The aims of this study were to assess psychological distress and state and trait anxiety in mothers of children with GERD, and to explore possible changes after antireflux surgery. METHODS: Mothers of children referred for antireflux surgery were included in this prospective study. Standardized questionnaires were used to evaluate psychological distress and state and trait anxiety before and 12 months after antireflux surgery. RESULTS: Of 87 eligible mothers of children with GERD, 62 (71%) agreed to participate. All children had objectively verified GERD by 24-hour pH-monitoring and/or upper gastrointestinal contrast study and unsatisfactory symptom relief of pharmacological treatment. Thirty-one (50%) mothers returned questionnaires postoperatively. Preoperatively, mothers of children undergoing antireflux surgery reported high levels of psychological distress and state anxiety, and 54% had scores indicating clinically significant psychological distress. None of the preoperative child characteristics were found to significantly influence maternal psychological distress or state anxiety. Twelve months postoperatively, both psychological distress and state anxiety were reduced. CONCLUSIONS: Mothers of children undergoing antireflux surgery reported reduced levels of psychological distress and state anxiety 12 months after the operation.

Quality of life in children who have undergone fundoplication surgery for the treatment of gastroesophageal reflux disease: a review of literature.

Health-related quality of life (QOL) in children is not just related to physical symptoms but also how a disease impacts them psychosocially-mental, emotional, behavioral, and school functioning, all of which contribute to the growth and development of a child. A chronic disease, such as gastroesophageal reflux disease (GERD) characterized by troublesome symptoms and complications, can significantly impair a child's QOL. This makes it vital that treatment options aim at addressing this. Fundoplication, the surgical treatment for GERD, is one of the most common upper gastrointestinal surgeries performed by pediatric surgeons. As with any medical treatment, there is an inherent need to determine the efficacy of the procedure not only in terms of objective physiologic measures but also QOL measures for both the children and parents. There are currently limited and inconsistent data on QOL outcomes postfundoplication in children with GERD. This literature review aims at critically analyzing the data by comparing current trends with research and identifying gaps in evidence to justify the need for further research within the field.

Longitudinal comparison of quality of life in patients undergoing laparoscopic Toupet fundoplication versus magnetic sphincter augmentation: Observational cohort study with propensity score analysis.

Only a minority of patients with gastro-esophageal reflux disease (GERD) are offered a surgical option. This is mostly due to the fear of potential side effects, the variable success rate, and the extreme alteration of gastric anatomy with the current gold standard, the laparoscopic Nissen fundoplication. It has been reported that laparoscopic Toupet fundoplication (LTF) and laparoscopic sphincter augmentation using a magnetic device (LINX) can treat reflux more physiologically and with a lower incidence of side-effects and reoperation rate. We present the first comparing quality of life in patients undergoing LTF versus LINX.Observational cohort study. Consecutive patients undergoing LTF or LINX over the same time period were compared by using the propensity score full matching method and generalized estimating equation. Criteria of exclusion were >3 cm hiatal hernia, grade C-D esophagitis, ineffective esophageal motility, body mass index >35, and previous upper abdominal surgery. The primary study outcome was quality of life measured with the Gastro-Esophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) questionnaire. Secondary outcomes were proton pump inhibitors (PPI) use, presence of gas-related symptoms or dysphagia, and reoperation-free probability.Between March 2007 and July 2014, 238 patients with GERD met the criteria of inclusion in the study. Of these, 103 underwent an LTF and 135 a LINX procedure. All patients had a minimum 1-year follow-up. Over time, patients in both groups had similar GERD-HRQL scores (odds ratio [OR] 1.04, confidence interval [CI] 0.89-1.27; P = 0.578), PPI use (OR 1.18, CI 0.81-1.70; P = 0.388), gas-related symptoms (OR 0.69, CI 0.21-2.28; P = 0.542), dysphagia (OR 0.62, CI 0.26-1.30; P = 0.241), and reoperation-free probability (stratified log-rank test = 0.556).In 2 concurrent cohorts of patients with early stage GERD undergoing LTF or LINX and matched by propensity score analysis, health-related quality of life significantly improved and GERD-HRQL scores had a similar decreasing trend over time up to 7 years of follow-up. We conclude that LTF and LINX provide similar disease-specific quality of life over time in patients with early stage GERD.

Patient satisfaction and quality of life following laparoscopic Nissen fundoplication.

BACKGROUND: Today, antireflux surgery has an established position in the management of gastroesophageal reflux disease. Some case series have shown good short-term results, but there is still little information regarding long-term results. Studies have recently focused on evaluating residual symptomatology and its impact on quality of life. OBJECTIVES: To determine the postoperative quality of life and degree of satisfaction in patients that underwent laparoscopic Nissen fundoplication. PATIENTS AND METHODS: A total of 100 patients (59 women and 41 men) were studied after having undergone laparoscopic Nissen fundoplication. The variables analyzed were level of satisfaction, gastrointestinal quality of life index (GIQLI), residual symptoms, and the Visick scale. RESULTS: No variation was found in relation to sex; 49 men and 51 women participated in the study. The mean age was 49 years. The degree of satisfaction encountered was: satisfactory in 81 patients, moderate in 3, and bad in 2 patients. More than 90% of the patients would undergo the surgery again or recommend it. The Carlsson score showed improvement at the end of the study (p<0.05). In relation to the GIQLI, a median of 100.61 points±21.624 was obtained. Abdominal bloating, regurgitation, and early satiety were the most frequent residual symptoms. The effect on lifestyle measured by the Visick scale was excellent. CONCLUSIONS: The level of satisfaction and quality of life obtained were comparable with reported standards; and the residual symptoms after antireflux surgery were easily controlled.

Defining the learning curve of laparoendoscopic single-site Heller myotomy.

Initial outcomes suggest laparoendoscopic single-site (LESS) Heller myotomy with anterior fundoplication provides safe, efficacious, and cosmetically superior outcomes relative to conventional laparoscopy. This study was undertaken to define the learning curve of LESS Heller myotomy with anterior fundoplication. One hundred patients underwent LESS Heller myotomy with anterior fundoplication. Symptom frequency and severity were scored using a Likert scale (0 = never/not bothersome to 10 = always/very bothersome). Symptom resolution, additional trocars, and complications were compared among patient quartiles. Median data are presented. Preoperative frequency/severity scores were: dysphagia = 10/8 and regurgitation = 8/7. Additional trocars were placed in 12 patients (10%), of whom all were in the first two quartiles. Esophagotomy/gastrotomy occurred in three patients. Postoperative complications occurred in 9 per cent. No conversions to "open" operations occurred. Length of stay was 1 day. Postoperative frequency/severity scores were: dysphagia = 2/0 and regurgitation = 0/0; scores were less than before myotomy (P < 0.001). There were no apparent scars, except where additional trocars were placed. LESS Heller myotomy with anterior fundoplication well palliates symptoms of achalasia with no apparent scar. Placement of additional trocars only occurred early in the experience. For surgeons proficient with the conventional laparoscopic approach, the learning curve of LESS Heller myotomy with anterior fundoplication is short and safe, because proficiency is quickly attained.

Gas-related symptoms after antireflux surgery.

BACKGROUND: Gas-related symptoms such as bloating, flatulence, and impaired ability to belch are frequent after antireflux surgery, but it is not known how these symptoms affect patient satisfaction with the procedure or what determines the severity of these complaints. We aimed to assess the impact of gas-related symptoms on patient-perceived success of surgery and to determine whether the severity of gas-related complaints after antireflux surgery is associated with objectively measured abnormalities. METHODS: Fifty-two patients were studied at a median of 27 months after antireflux surgery. The influence of gas-related symptoms on their quality of life and satisfaction with surgical outcome was assessed. The rates of air swallows and gastric and supragastric belches before and after surgery were assessed using impedance measurements. RESULTS: Bloating and flatulence were associated with a decreased quality of life and less satisfaction with surgical outcome. Notably, 9 % of the patients would not opt for surgery again due to gas-related symptoms. Antireflux surgery decreased the total number of gastric belches but did not affect the number of air swallows. The severity of gas-related symptoms was not associated with an increased number of preoperative air swallows and/or belches or a larger postoperative decrease in the number of gastric belches. CONCLUSION: Gas-related symptoms are associated with less satisfaction with surgical outcome. The severity of gas-related symptoms is not determined by the number of preoperative air swallows or a more severe impairment of the ability to belch after surgery. Preoperative predictors of postoperative gas-related symptoms therefore could not be identified.

Impact of transoral incisionless fundoplication (TIF) on subjective and objective GERD indices: a systematic review of the published literature.

BACKGROUND: Gastroesophageal reflux disease (GERD) remains a significant problem for the medical community. Many endoluminal treatments for GERD have been developed with little success. Currently, transoral incisionless fundoplication (TIF) attempts to recreate a surgical fundoplication through placement of full-thickness polypropylene H-fasteners. This, the most recent procedure to gain FDA approval, has shown some promise in the early data. However, questions of its safety profile, efficacy, and durability remain. METHODS: The Cochrane Library and MEDLINE through PubMed were searched to identify published studies reporting on subjective and objective GERD indices after TIF. The search was limited to human studies published in English from 2006 up to March 2012. Data collected included GERD-HRQL and RSI scores, PPI discontinuation and patient satisfaction rates, pH study metrics, complications, and treatment failures. Statistical analysis was performed with weighted t tests. RESULTS: Titles and abstracts of 214 papers were initially reviewed. Fifteen studies were found to be eligible, reporting on over 550 procedures. Both GERD-HRQL scores (21.9 vs. 5.9, p < 0.0001) and RSI scores (24.5 vs. 5.4, p ≤ 0.0001) were significantly reduced after TIF. Overall patient satisfaction was 72 %. The overall rate of PPI discontinuation was 67 % across all studies, with a mean follow-up of 8.3 months. pH metrics were not consistently normalized. The major complication rate was 3.2 % and the failure rate was 7.2 % across all studies. CONCLUSION: TIF appears to provide symptomatic relief with reasonable levels of patient satisfaction at short-term follow-up. A well-designed prospective clinical trial is needed to assess the effectiveness and durability of TIF as well as to identify the patient population that will benefit from this procedure.

Causes of dissatisfaction after laparoscopic fundoplication: the impact of new symptoms, recurrent symptoms, and the patient experience.

BACKGROUND: Although laparoscopic fundoplication effectively alleviates gastroesophageal reflux disease (GERD) in the great majority of patients, some patients remain dissatisfied after the operation. This study was undertaken to report the outcomes of these patients and to determine the causes of dissatisfaction after laparoscopic fundoplication. METHODS: All patients undergoing laparoscopic fundoplication in the authors' series from 1992 to 2010 were evaluated for frequency and severity of symptoms before and after laparoscopic fundoplication, and their experiences were graded from "very satisfying" to "very unsatisfying." Objective outcomes were determined by endoscopy, barium swallow, and pH monitoring. Primary complaints were derived from postoperative surveys. Median data are reported. RESULTS: Of the 1,063 patients undergoing laparoscopic fundoplication, 101 patients reported dissatisfaction after the procedure. The follow-up period was 33 months. The dissatisfied patients (n = 101) were more likely than the satisfied patients to have postoperative complications (9 vs 4 %; p < 0.05) and to have undergone a prior fundoplication (22 vs 11 %; p < 0.05). For the dissatisfied patients, heartburn decreased in frequency and severity after fundoplication (p < 0.05) but remained notable. Also for the dissatisfied patients, new symptoms (gas bloat/dysphagia) were the most prominent postoperative complaint (59 %), followed by symptom recurrence (23 %), symptom persistence (4 %), and the overall experience (14 %). Primary complaints of new symptoms were most common within the first year of follow-up assessment and less frequent thereafter. Primary complaints of recurrent symptoms generally occurred more than 1 year after fundoplication. CONCLUSIONS: Dissatisfaction is uncommon after laparoscopic fundoplication. New symptoms, such as dysphagia and gas/bloating, are primary causes of dissatisfaction despite general reflux alleviation among these patients. New symptoms occur sooner after fundoplication than recurrent symptoms and may become less common with time.

Roux-en-Y reconstruction is superior to redo fundoplication in a subset of patients with failed antireflux surgery.

BACKGROUND: A subset of patients requires reoperative antireflux surgery (Re-ARS) after failed fundoplication. The aim of this study was to determine symptomatic outcomes beyond 1 year following Re-ARS and to assess the relative utility of two different surgical approaches. METHODS: After Institutional Review Board approval, patients who underwent Re-ARS were identified from a prospective database. Symptom severity was graded on a 0-3 scale. Patients with postoperative symptoms of grade ≥ 2 were considered to have a poor outcome. Patient satisfaction was graded using a 10-point visual analog scale. RESULTS: At least 1 year of follow-up was available for 130 patients. There were 94 redo fundoplications (RF) and 36 Roux-en-Y reconstructions (RNYR). Symptom risk factors (significant preoperative dysphagia, significant preoperative heartburn, esophageal dysmotility, short esophagus, delayed gastric emptying, multiple failed hiatal surgeries, reflux-related respiratory symptoms) were more prevalent in patients who underwent RNYR compared to RF (mean 3.0 vs. 2.2; p = 0.003). Postoperative leaks and major complications occurred in 4.5 % (5/110) versus 0% and 21.6 % versus 33.3 % of the RF and RNYR groups, respectively. Twenty-eight RF patients (29.8 %) and 9 RNYR patients (25.0 %) reported poor outcomes. Among patients with ≥ 4 risk factors, those who underwent RNYR had a lower incidence of poor outcome (7.7 % vs. 55 %, p = 0.018) and higher satisfaction scores (8.4 vs. 5.8, p = 0.001) compared to those who had RF. Overall, 85 % of patients were satisfied or highly satisfied with their results and the average satisfaction score was 8.2. CONCLUSION: Re-ARS provides good subjective outcomes when measured more than 1 year after surgery. Patients with more complex pathology benefit more from RNYR despite the higher postoperative complication rate. This is especially true for patients with decreased esophageal motility and short esophagus.

Predicting patient dissatisfaction following laparoscopic Nissen fundoplication: an analysis of symptoms.

BACKGROUND: Nissen fundoplication is a well-established treatment for gastroesophageal reflux disease (GERD) with a high success rate and a long-lasting effect. However, the literature reports that a persistent, small group of patients is not fully satisfied with the outcome. Identifying this patient group preoperatively would prevent disappointment for both patients and surgeon. This has proven difficult since dissatisfaction was related to nondisease-related factors instead of typical symptoms of GERD or the objective findings of investigations. We studied our series of patients who underwent laparoscopic Nissen fundoplication to identify predictors of patient dissatisfaction and the impact of surgery on individual symptoms. METHODS: All consecutive private patients undergoing Nissen fundoplication were asked to complete a preoperative and postoperative questionnaire concerning symptoms, medication use, and satisfaction. Demographics, investigations, complications, and reinterventions were documented. A standard laparoscopic Nissen fundoplication was performed. RESULTS: Over an 11-year period 222 patients underwent surgery for GERD. The postoperative response rate to the questionnaire was 77.5 %, with dissatisfaction reported by 12.8 % of the patients. Of these dissatisfied patients, only 13.6 % had proven disease recurrence. Both satisfied and dissatisfied patients presented with an inconsistent pattern of symptoms. None of the preoperative symptoms and investigations or the patient's age and gender was predictive of postoperative dissatisfaction. Only postoperative heartburn, regurgitation, and bloating significantly correlated with patient dissatisfaction. CONCLUSION: Nissen fundoplication has a very high satisfaction rate overall. A small percentage of patients are not fully satisfied and dissatisfaction is associated with reported persistent symptoms and side effects of surgery rather than gender or preoperative symptom pattern, severity of esophagitis, or total 24 h esophageal acid exposure.

Well-being of children with neurologic impairment after fundoplication and gastrojejunostomy tube feeding.

BACKGROUND: There is limited understanding on the impact of fundoplication or gastrojejunostomy tube (GJT) feeding in children with neurologic impairment who have swallowing dysfunction, gastroesophageal reflux disease, and/or dysmotility. OBJECTIVE: To explore and understand the well-being of families and their children with neurologic impairment who had either a fundoplication or GJT. METHODS: This was a qualitative study using in-depth, individual interviews with parents of children with severe neurologic impairment who had either a fundoplication with gastrostomy or GJT. Parents' perceptions of daily life and QoL were explored in the context of the interventions. Interviews were transcribed, and data were analyzed using qualitative content analysis. RESULTS: Children and their parents are profoundly impacted by the health condition of the children. QoL effects were similar across spheres of individual and family experience and well-being. Themes related to QoL were: physical health of the child and the future, intense caregiving needs, social isolation and stigma, pervasive impact on the family, financial strain, and the process of finding meaning. Fundoplication and GJT affected feeding tolerance and times, caregiving, and health care utilization. Parents identified how changes in these factors influenced child, parental, and family QoL. CONCLUSIONS: The diverse influences of the underlying condition and the interventions should be addressed in the delivery of health services. Future studies of the effectiveness of fundoplication and GJT feeding should address the well-being of the child and family, the impact on family caregiving, and health care utilization.

Laparoscopic Nissen fundoplication for improved gastrointestinal symptoms and quality of life.

OBJECTIVE: The purpose of this study was to establish baseline data for a procedure that has yet to be defined within a Caribbean population. Using a specifically designed postoperative questionnaire, symptomatology and quality of life were assessed before and after laparoscopic Nissen fundoplication. METHODS: Twenty-three consecutive patients of the same surgeon were identified. The questionnaires measured the symptoms and social and emotional functioning, assigning each a score for comparative purposes. The cumulative score was considered the ultimate index of overall quality of life. Wilcoxon matched pairs test was used to analyse the data. RESULTS: The mean age of the patients was 47.5 years. There were 21females and 2 males. Heartburn (78.3%) and regurgitation (60.8%) were the main symptoms. Postoperatively, these decreased to 17.3% and 4.3% respectively, with significant declines in other complaints such as dysphagia and nausea. The social and emotional functioning score had an average of 13.2 preoperatively; this increased to 18.3, postoperatively, out of a possible maximum of 20. None of the procedures had to be converted to open laparotomy and mean operating time was 108 minutes. Mean follow-up time was 9.7 months. CONCLUSION: Laparoscopic Nissen fundoplication does provide significant improvement in overall quality of life among patients with gastrointestinal symptoms and can be performed effectively within a Caribbean setting.

Laparoscopic nissen Fundoplication for improved gastrointestinal symptoms and quality of life / Fundoplicación laparoscópica de Nissen para mejorar los síntomas gastrointestinales y la calidad de vida

OBJECTIVE: The purpose of this study was to establish baseline data for a procedure that has yet to be defined within a Caribbean population. Using a specifically designed postoperative questionnaire, symptomatology and quality of life were assessed before and after laparoscopic Nissen fundoplication. METHODS: Twenty-three consecutive patients of the same surgeon were identified. The questionnaires measured the symptoms and social and emotional functioning, assigning each a score for comparative purposes. The cumulative score was considered the ultimate index of overall quality of life. Wilcoxon matched pairs test was used to analyse the data. RESULTS: The mean age of the patients was 47.5 years. There were 21 females and 2 males. Heartburn (78.3%) and regurgitation (60.8%) were the main symptoms. Postoperatively, these decreased to 17.3% and 4.3% respectively, with significant declines in other complaints such as dysphagia and nausea. The social and emotional functioning score had an average of 13.2 preoperatively; this increased to 18.3, postoperatively, out of a possible maximum of 20. None of the procedures had to be converted to open laparotomy and mean operating time was 108 minutes. Mean follow-up time was 9.7 months. CONCLUSION: Laparoscopic Nissen fundoplication does provide significant improvement in overall quality of life among patients with gastrointestinal symptoms and can be performed effectively within a Caribbean setting.

OBJETIVO: El propósito de este estudio fue establecer los datos básicos para un procedimiento que tiene que ser definido todavía en el contexto de una población caribeña. Usando una encuesta postoperatoria específicamente diseñada, la sintomatología y la calidad de vida fueron evaluadas antes y después de la fundoplicación laparoscópica de Nissen. MÉTODOS: Se identificaron veintitrés pacientes consecutivos del mismo cirujano. Las encuestas midieron los síntomas así como el funcionamiento social y emocional, asignando a cada uno una puntuación a fin de establecer comparaciones. La puntuación cumulativa fue considerada el índice final de la calidad general de vida. La prueba de pares equiparados de Wilcoxon se usó para analizar los datos. RESULTADOS: La edad promedio de los pacientes (21 hembras y 2 varones) fue 47.5 años. La acidez estomacal (78.3%) y la regurgitación (60.8%) fueron los síntomas principales. Postoperatoriamente, éstos disminuyeron a 17.3% y 4.3% respectivamente, con disminuciones significativas en el caso de otras dolencias, tales como la disfagia y la náusea. La puntuación del funcionamiento social y emocional tuvo un promedio de 13.2 preoperatoriamente. Este aumentó a 18.3 postoperatoriamente, de un máximo posible de 20. Ninguno de los procedimientos tuvo que ser convertido a laparotomía abierta y el tiempo promedio de operación fue de 108 minutos. El tiempo promedio de seguimiento fue de 9.7 meses. CONCLUSIÓN: La fundoplicación laparoscópica de Nissen proporciona un mejoramiento significativo de la calidad general de vida entre los pacientes con síntomas GI y puede realizarse de modo efectivo en un contexto caribeño.

Laparoscopic Nissen fundoplication in patients with nonerosive reflux disease. Long-term quality-of-life assessment and surgical outcome.

BACKGROUND: It is known that laparoscopic antireflux surgery (LARS) can achieve an excellent surgical outcome including quality of life improvement in patients with erosive gastroesophageal reflux disease (GERD; EGD-positive). Less is known about the long-term surgical outcome in GERD patients who have no evidence of esophagitis (EGD-negative) before surgery. The aim of this study was to evaluate the surgical outcome in a well-selected group of EGD-negative patients compared to that of EGD-positive patients. METHODS: From a large sample of more than 500 patients who underwent LARS, 89 EGD-negative patients (mean age, 51 +/- 6 years; 56 males) were treated surgically because of persistent reflux-related symptoms despite medical therapy. In all cases, preoperative 24-h pH monitoring showed pathological values. To perform a comparative analysis, a matched sample of EGD-positive patients (mean age, 54 +/- 10 years; 58 males) was selected from the database. Surgical outcome included for all patients objective data (e.g., manometry and pH data and endoscopy), quality of life evaluation [Gastrointestinal Quality of Life Index (GIQLI)] symptom evaluation, as well as patients' satisfaction with surgery. The data of a complete 5-year follow-up are available. RESULTS: There were no significant differences in symptomatic improvement, percentage of persistent surgical side-effects, or objective parameters. In general, patients' satisfaction with surgery was comparable in both groups: 95% rated long-term outcome as excellent or good and would undergo surgical treatment again if necessary, respectively. Quality of life improvement was significantly better (p < 0.05) in the EGD-negative group because of the fact that GIQLI was more impaired before surgery (preoperative GIQLI, 81.7 +/- 11.6 points/EGD-negative vs 93.8 +/- 10.3 points/EGD-positive). Five years after surgery, GIQLI in both groups (121.2 +/- 8.5 for EGD-negative vs 120.9 +/- 7.3 for EGD-positive) showed comparable values to healthy controls (122.6 +/- 8.5). CONCLUSION: We suggest that LARS is an excellent treatment option for well-selected patients with persistent GERD-related symptoms who have no endoscopic evidence of esophagitis.

Endoscopic full-thickness plication for the treatment of GERD: 12-month follow-up for the North American open-label trial.

BACKGROUND: The aim of this study was to assess the intermediate-term (12-month) safety and efficacy of endoscopic full-thickness plication in patients with symptomatic GERD. METHODS: Sixty-four patients with chronic heartburn that required maintenance antisecretory therapy received a single, endoscopically placed, full-thickness plication in the gastric cardia 1 cm distal to the gastroesophageal junction. At baseline and 12 months after plication, patients completed the GERD Health Related Quality of Life questionnaire, Gastrointestinal Symptom Rating Scale, and SF-36 Health Survey, as well as a medication use diary. Ambulatory 24-hour pH monitoring and esophageal manometry were obtained at baseline and 3 months after plication. At 6 months after plication, the 24-hour pH study was repeated. RESULTS: Of the 57 patients who completed the 12-month follow-up, 40 (70%) were no longer taking a proton pump inhibitor. Median GERD Health Related Quality of Life scores were improved compared with baseline while taking medication (19.0 vs. 5.0; p < 0.0001) and while not taking medication (13.0 vs. 5.0; p < 0.002). At 6 months after the procedure, an improvement in distal esophageal acid exposure was demonstrated in 40 of 51 patients (80%), with a decrease of 39% in the median percentage of time the pH was less than 4 (p < 0.0001). Normal pH scores were observed in 30% of patients. All procedure-related adverse events occurred acutely, as previously reported, and no new adverse event was observed during extended follow-up. CONCLUSIONS: Full-thickness plication at the gastroesophageal junction is an effective endoscopic procedure for treatment of patients with symptoms caused by GERD. It reduces reflux symptoms and antisecretory medication use over at least a 1-year period.

Patients' experiences of illness, operation and outcome with reference to gastro-oesophageal reflux disease.

BACKGROUND: Describing the illness-story from a patient perspective could increase understanding of living with a chronic disease for health professionals and others, facilitate decision-making about treatment and enhance information about the outcome from a patient perspective. AIM: To illuminate patients' illness experiences of having a gastro-oesophageal reflux disease (GORD), going through surgery and the outcome. METHODS: Twelve patients were interviewed 5 years after having had the operation; six patients had had fundoplication via laparoscopy and six via open surgery. Each patient was asked to talk openly about their experiences, thoughts, feelings and consequences of living with the illness, going through surgery and the period from surgery to the day of interview. A qualitative content analysis was performed concerning the context of the data and its meaning. FINDINGS: Three central categories were identified and nine subcategories: living with GORD- symptoms of the disease affecting daily living, taking medicines, work, family and social life; concerns related to surgery- decision-making about the operation, influence by physicians; life after the operation- outcomes and consequences, side-effects and complications of the operation, sick leave, information and sharing experiences with future patients. All patients were free from symptoms of the illness after surgery independent of type of surgery, but side-effects from surgical treatment varied individually. Interviewees would have liked information concerning side-effects after surgery from previous patients. CONCLUSIONS: This study contributes to knowledge about patients' long-term suffering, their control of symptoms and how they have tried to cure themselves, but also about their concerns about surgery and the importance of surgical treatment to their quality of life. They wanted information about treatment, outcome and consequences, not only from a health care perspective but also from previous patients having had the same treatment.

Anxiety disorder after laparoscopic refundoplication as a cause of dysphagia.

Side effects of laparoscopic antireflux surgery doubtless have a negative effect on patients' satisfaction with surgical outcome and quality of life. Until now, side effects of laparoscopic antireflux surgery such as dysphagia have not been reported as associated with the origin of psychiatric disorders. We report the case of a 71-year-old man who underwent laparoscopic refundoplication because of a "slipping" Nissen 2 years after primary intervention. After operation, the patient suffered from severe dysphagia and required pneumatic dilation. In this patient, severe dysphagia has caused panic disorder. Complete relief of dysphagia was achieved by single dilation. In contrast, panic symptoms in relation to daily ingestion continued for at least 6 weeks after surgery. A mild level of anxiety without panic symptoms existed for the first 3 months after reoperation.

What did the laparoscopic Nissen approach of the gastro-oesophageal reflux really change for the patients 8 years later?

BACKGROUND: Nissen fundoplication (NF) is recognized as the surgical treatment of the gastro-oesophageal reflux disease (GERD). NF can be achieved either by open surgery or by laparoscopic approach. METHODS: From 1987 to 1997, 210 patients were treated for GERD by NF: 61 by open and 149 by laparoscopic approach. All the patients were followed more than 1 year and were scored by clinical assessment (Visick scale adaptation). In case of Visick score > 1, GI-endoscopy, X-ray series or 24-hour pH-study complete the evaluation. RESULTS: The operative time was comparable between both groups. The postoperative recovery was statistically faster in the laparoscopic group (p = 0.0001). The mean time of follow-up was 6 years after open NF and 4 years after laparoscopic NF. After open NF or laparoscopic NF, 72% and 67% of the patients are respectively scored Visick 1, 13% and 21%--Visick 2, 6.8% and 6%--Visick 3 and 8.2% and 6%--Visick 4 (NS). Patients with recurrence of GERD were scored Visick 4, so failure of the surgical treatment is observed in 5 patients after open NF and 9 patients after laparoscopic NF. The occurrence of incisional hernia was significantly higher in the open group (p = 0.0001). CONCLUSION: NF remains a safe procedure for surgical treatment of GERD and can be achieved by laparoscopic approach with comparable results to those by open laparotomy. In our experience, the advantages of the laparoscopic approach is a faster postoperative recovery and a lower risk of incisional hernia.