Magnus Ruth

Tailoring antireflux surgery: A randomized clinical trial.

Abstract. A hypothesis has been formulated that mandates the adjustment of antireflux surgery to either a total or a partial wrap depending on the motor function of the esophagus to avoid dysphagia and other obstructive complaints. This hypothesis has been tested in a randomized, clinical trial where 106 chronic gastroesophageal reflux patients were allocated to either a total Nissen-Rossetti (n= 53) or a Toupet partial posterior (n= 53) fundoplication, irrespective of their preoperative esophageal motor function. All patients were followed at least 3 years, during which time none had a relapse of moderate to severe reflux symptoms. Motor dysfunctions defined as peristaltic amplitude ≤ 30 mmHg in the distal third and failed primary peristalsis with or without > 20% simultaneous contractions were noted in 67 patients preoperatively, but these patients did not have a specific symptom profile (e.g., dominated by obstructive symptoms) nor did seven patients with “aperistaltic esophagus.” The incidence of dysphagia decreased from 20% preoperatively to 8% (mild) at 3 years after the operation with no difference between the surgical procedures. We were unable to demonstrate a relation between preoperative manometric findings and postoperative symptoms when assessed in the total group or when subdivided by the type of fundoplication (r < 0.3). Flatulence occurred more frequently among those with a total fundic wrap (p < 0.01). When patients representing motor dysfunction (see above) were specifically analyzed, we again observed no difference in outcome between those having a total or a partial fundic wrap. In conclusion, the concept of tailoring antireflux surgery based on the preoperative motor function of the esophagus in patients with chronic gastroesophageal reflux disease was not supported by the results of this clinical trial.

Pneumatic dilatation or laparoscopic cardiomyotomy in the management of newly diagnosed idiopathic achalasia. Results of a randomized controlled trial.

BackgroundThe most effective therapeutic strategy in newly diagnosed achalasia is yet to be established. Therefore we designed a study in which pneumatic dilatation was compared to laparoscopic cardiomyotomy to which was added a partial posterior fundoplication.Patients and ResultsA series of 51 patients (24 males, mean age 44 years) were randomly allocated to the therapeutic modalities (dilatation = 26, surgery = 25). All patients were followed for at least 12 months, and during that period the pneumatic dilatations strategy had significantly more treatment failures (P = 0.04). Only minor differences emerged between the study groups when symptoms, dysphagia scorings, and quality-of-life assessments were evaluated 12 months after initiation of therapy.ConclusionsLaparoscopic myotomy was found to be superior to an endoscopic balloon dilatation strategy in the treatment of achalasia when studied during the first 12 months after treatment.

Long-term efficacy of total (Nissen-Rossetti) and posterior partial (Toupet) fundoplication: Results of a randomized clinical trial

The efficacy of fundoplication operations in the long-term management of gastroesophageal reflux disease (GERD) has been documented. However, only a few prospective controlled series support the longterm (>10 years) efficacy of these procedures, and further data are required to also determine whether the type of fundoplication affects the frequency of postfundoplication complaints. The aim of this study was to conduct a randomized, controlled clinical trial to assess the long-term symptomatic outcome of a partial posterior fundoplication as compared to a total fundic wrap. During the years 1983 to 1991, a total of 13 7 patients with chronic gastroesophageal reflux disease were enrolled in the study; 72 were randomized to semifundoplication (Toupet) and 65 to total fundoplication (Nissen-Rossetti). A standardized symptom questionnaire was used for follow-up of these patients. A total of 110 patients completed a median follow-up of 11.5 years; 54 had a total wrap and 56 underwent a partial posterior fundoplication. During this period, seven patients required reoperation (Nissen-Rossetti in 5 and Toupet in 2), 11 patients died, and nine patients were lost to follow-up or did not comply with the follow-up program. Control of heartburn (no symptoms or mild, intermittent symptoms) was achieved in 88% and 92% in the total and partial fundoplication groups, respectively, and the corresponding figures for control of acid regurgitation were 90% and 94%. We observed no difference in dysphagia scoring between the two groups, although odynophagia was somewhat more frequently reported in those undergoing a total fundoplication. On the other hand, a significant difference was observed in the prevalence of rectal flatus and postprandial fullness, which were recorded significantly more often in those undergoing a total fundoplication (P < 0.001 and P < 0.03, respectively). Posterior partial fundoplication seems to maintain the same high level of reflux control as total fundoplication. Earlier observations demonstrating the advantages of a partial fundoplication, which included fewer complaints associated with gas-bloat, continue to be valid after more than 10 years of follow-up.

Lower esophageal sphincter characteristics and esophageal acid exposure following partial or 360‡ fundoplication: Results of a prospective, randomized, clinical study

AbstractIn a prospective, randomized, clinical trial, we compared a partial (180–200‡, Toupet) with a total fundoplication (360‡, Rossetti) in the surgical treatment of gastroesophageal reflux disease. Seventy-one patients entered the trial; 33 were allocated to a partial fundoplication and 38 to a 360‡ fundic wrap. Each patient was investigated prior to as well as 3 and/or 6 months after the operation, including an endoscopic and clinical assessment. Manometry was carried out via a triple lumen catheter and the pressure in the high pressure zone (HPZ) in the distal esophagus was measured as well as the length of the intraabdominal segment by a “station pull-through” technique. Acid exposure of the esophageal mucosa was evaluated by ambulatory 24-hour pH measurements.nAcid exposure of the esophageal mucosa was “normalized” by the 2 operations. In addition, the length of the HPZ was increased to a “normal” level by both operations. The pressure of the HPZ was, however, “normalized” only in patients allocated to a Rossetti fundoplication, whereas patients operated on with a partial fundoplication had a significantly lower HPZ pressure (p<0.01). The clinical assessment revealed excellent results in both groups with no significant differences between the 2 operations except for a higher incidence of dysphagia at 3 months after a Rossetti fundoplication (p<0.01), which disappeared during the subsequent 3 months.RésuméDans une étude clinique prospective, randomisée, nous avons comparé la plicature partielle de la grosse tubérosité (180–200‡, opération dA. Toupet) et la plicature totale (opération de Nissen-Rossetti) dans le traitement chirurgical du reflux gastrooesophagien. Parmi les 71 patients inclus dans cette étude, 33 ont eu une plicature partielle et 38, une plicature totale. Chaque patient a eu un examen clinique complet et endoscopique avant son intervention, et 3 et 6 mois après. Tous les patients ont eu une manométrie par cathéter à trois lumières, une mesure de lhyperpression de loesophage distal, ainsi que la celle de la longeur de loesophage intra-abdominal. Une pH-métrie a été effectuée pendant 24 heures en ambulatoire pour mesurer lexposition “acide” de loesophage.Lexposition “acide” a été corrigée par les deux opérations. La pression du bas oesophage na été, par contre, que “normalisée” chez les patients ayant eu une plicature totale alors quelle a été nettement abaissée chez ceux ayant eu une fundoplicature partielle (p<0.01). Lexamen clinique a montré quil ny avait pas de différence significative dans les 2 groupes à part une incidence plus élèvée de dysphagie à 3 mois après lopération de Nissen-Rossetti. Cette différence disparaissait après 3 mois.ResumenEn un estudio clínico prospectivo y randomizado hemos comparado una fundoplicación parcial (180–200‡, Toupet) con una total (360‡, Rossetti) en el tratamiento quirÚrgico del reflujo gastroesofágico. Setena y un pacientes ingresaron al estudio; 33 resultaron asignados a fundoplicación parcial y 38 a la total. Cada paciente fue estudiado, antes de la operación y 3 y/o 6 meses después, por endoscopia y valoración clínica. Se realizó manometría por medio de un catéter de triple luz y se efectuó la determinación de la presión en la zona de alta presión (ZAP) del esófago distal, así como la longitud del segmento intraabdominal. La exposición de la mucosa esofágica al ácido fue determinanda por mediciones ambulatorias del pH (24 horas).La exposición de la mucosa esofágica fue “normalizada” por las 2 operaciones. Además, la longitud de la ZAP fue elevada a un nivel “normal” or ambas operaciones. La presión de la ZAP, sin embargo, sólo fue “normalizada” en los pacientes asignados a la fundoplicación de Rossetti, en tanto que los pacientes tratados con la fundoplicación parcial exhibieron una menor presión en la ZAP (p<0.01). La valoración clínica reveló excelentes resultados en ambos grupos sin diferencia entre las 2 operaciones, excepto por una incidencia mayor de disfagia a los 3 meses después de la fundoplicación, una diferencia que desvaneció en los 3 meses siguientes.

Does massive obesity promote abnormal gastroesophageal reflux

Fifty consecutive massively obese patients referred for gastroplasty operations were prospectively studied to determine the existence of gastroesophageal reflux disease by means of a standardized questionnaire, 24-hr ambulatory pH-metry, and endoscopy (27 females, mean age 48 years, range 38–57 years). These patients had a body mass index (BMI) of 42.5±5.2 kg/m2 and an actual weight of 125.5±17 kg. Heartburn and acid regurgitation was reported by 37% and 28%, respectively, mostly of a mild degree (22% and 20%). Dysphagia was reported by 2%, but none had odynophagia. No patient had any macroscopic esophagitis. The pH data were compared with those obtained in 29 age- and sex-matched, symptom-free, healthy controls (15 females, mean age 47.6 years, range 30–63 years). During ambulatory pH-metry, we recorded a predominance of daytime reflux (7.2±8.2% and a total acid exposure of 5.3±6.4%) in the obese patients, but neither the weight, BMI, nor the waist-hip ratio were significantly correlated with any of the reflux variables. The pH data obtained from these patients did not, however, differ significantly from those recorded in the control population, although a somewhat lower daytime acid reflux was found in the latter group. These results suggest that massive overweight is not associated with an increased prevalence of gastroesophageal reflux disease.

Baclofen-mediated gastro-oesophageal acid reflux control in patients with established reflux disease

To explore the effect of baclofen on oesophageal acid exposure in patients with gastro‐oesophageal reflux disease.

Efficacy of an anterior as compared with a posterior laparoscopic partial fundoplication: results of a randomized, controlled clinical trial.

Objective The aim of the study was to compare the efficacy and mechanical consequences of 2 partial fundoplications performed laparoscopically under the framework of a randomized, controlled clinical trial. Summary Background Data Although laparoscopic total fundoplication procedures have proven their effectiveness in the control of gastroesophageal reflux, problems remain with the functional consequences after a supra-competent gastric cardia high-pressure zone. Partial fundoplications have been found to be associated with fewer mechanical side effects. Patients and Methods During a 2-year period, 95 patients with gastroesophageal reflux disease were enrolled into a randomized, controlled single-institution clinical trial comparing a partial posterior (Toupét, n = 48) fundoplication and an anterior partial wrap (Watson, n = 47). All patients were assessed postoperatively at predefined time points, and the 12-month follow-up data are presented in terms of clinical results and 24-hour pH monitoring variables. Results Both patient groups were strictly comparable at the time of randomization. All operations were completed laparoscopically, and no serious complications were encountered. During the first postoperative year, a difference regarding the control of reflux symptoms was observed in favor of the posterior fundoplication. Esophageal acid exposure (% time pH <4) was substantially reduced by both operations but to a significantly lower level after a Toupét compared with the Watson partial fundoplication (1.0 ± 0.3 vs. 5.6 ± 1.1 mean ± SEM; p < 0.001). Postfundoplication symptoms were infrequently recorded with no difference between the groups. Conclusions When performing a laparoscopic partial fundoplication, the posterior modification (Toupét) offers advantages in terms of better reflux control compared with an anterior type (Watson).

24-H Pharyngeal pH Monitoring in Healthy Volunteers: A Normative Study

Background: Gastropharyngeal reflux has been associated with disorders of the upper and lower airways. It may be shown by pharyngeal pH-metry, but reports on normality in healthy volunteers are scarce. No definite consensus has been reached considering the upper limit of normality (ULN). The aim of the present study was therefore to quantify the occurrence of pharyngeal acid exposure (pH < 4) in healthy volunteers and, further, to examine its relation to acid exposure of the oesophagus and oesophageal motility and its occurrence in relation to age, sex, and body position. Methods: Forty healthy volunteers underwent ambulatory 24-h pH-metry, using antimony electrodes positioned 2 cm above the upper oesophageal sphincter and 5 cm above the lower oesophageal sphincter on the basis of manometry. Technical artefacts were excluded before calculation of all results. Results: Gastropharyngeal reflux occurred in most healthy volunteers without any significant relation to age, sex, or body weight. Pharyngeal acid reflux occurred mainly in the upright position. The ULN for pharyngeal acid exposure time was assessed to 0.9% (0.2% after exclusion of mealtimes). The ULN for the number of acid events in the pharynx was 18 (6.1). The corresponding ULNs for the oesophagus were 7% and 84. Conclusion: Gastropharyngeal reflux may be effectively monitored by ambulatory pH-metry. The present study provides reference limits, a prerequisite for evaluating the pathophysiologic importance of the phenomenon.BACKGROUNDnGastropharyngeal reflux has been associated with disorders of the upper and lower airways. It may be shown by pharyngeal pH-metry, but reports on normality in healthy volunteers are scarce. No definite consensus has been reached considering the upper limit of normality (ULN). The aim of the present study was therefore to quantify the occurrence of pharyngeal acid exposure (pH < 4) in healthy volunteers and, further, to examine its relation to acid exposure of the oesophagus and oesophageal motility and its occurrence in relation to age, sex, and body position.nnnMETHODSnForty healthy volunteers underwent ambulatory 24-h pH-metry, using antimony electrodes positioned 2 cm above the upper oesophageal sphincter and 5 cm above the lower oesophageal sphincter on the basis of manometry. Technical artefacts were excluded before calculation of all results.nnnRESULTSnGastropharyngeal reflux occurred in most healthy volunteers without any significant relation to age, sex, or body weight. Pharyngeal acid reflux occurred mainly in the upright position. The ULN for pharyngeal acid exposure time was assessed to 0.9% (0.2% after exclusion of mealtimes). The ULN for the number of acid events in the pharynx was 18 (6.1). The corresponding ULNs for the oesophagus were 7% and 84.nnnCONCLUSIONnGastropharyngeal reflux may be effectively monitored by ambulatory pH-metry. The present study provides reference limits, a prerequisite for evaluating the pathophysiologic importance of the phenomenon.

Evaluation of the response to treatment in patients with idiopathic achalasia by the timed barium esophagogram: results from a randomized clinical trial

SUMMARY n nTo choose which treatment would be most effective for the individual patient with newly diagnosed achalasia is difficult for the tending physician. A diagnostic tool that would allow prediction of the symptomatic and functional response after treatment for achalasia is therefore needed. The timed barium esophagogram (TBE) is a method that allows objective assessment of esophageal emptying, but the value of TBE in the clinical management of achalasia remains to be clarified. The aim of this study was first, to assess the ability of TBE to predict symptoms and treatment failure during post-treatment follow-up. Second, to determine whether esophageal emptying as assessed by TBE differs after treatment with pneumatic dilatation or laparoscopic myotomy. Fifty-one patients with newly diagnosed achalasia were prospectively randomized to pneumatic dilatation (nxa0=xa026) or laparoscopic myotomy (nxa0=xa025). Evaluation with TBE was performed before (nxa0=xa046) and after treatment (nxa0=xa043). The median interval between treatment and post-treatment TBE was 6 months, and the median follow-up time after the post-treatment TBE was 18 months. Following therapeutic intervention, TBE parameters did not differ significantly between treatment groups. However, significant correlations were found between the height of the barium column at 1xa0min and the symptom scores at the end of follow up for ‘dysphagia for liquids’ (Pxa0<xa00.05, rhoxa0=xa00.47), ‘chest pain’ (Pxa0<xa00.05, rhoxa0=xa00.42), and the ‘Watson dysphagia score’ (Pxa0<xa00.05, rhoxa0=xa00.46). Patients with less than 50% improvement in this TBE-parameter (height at 1xa0min) post-treatment had a 40% risk of treatment failure during follow-up. In summary, pneumatic balloon dilatation and laparoscopic myotomy similarly affected esophageal function as assessed by TBE-emptying. Lack of improvement in barium-column height post-treatment was associated with an increased risk of treatment failure which should motivate close surveillance in order to detect symptomatic recurrence at an early stage.

Factors predicting survival in patients with advanced oesophageal cancer: a prospective multicentre evaluation

Backgroundu2002 Oesophageal cancer is often diagnosed at an advanced stage, with poor prognosis and severe morbidity. In majority of cases, palliative treatment is the only option available.