A randomized trial on endoscopic full-thickness gastroplication versus laparoscopic antireflux surgery in GERD patients without hiatal hernias.

BACKGROUND AND GOALS: Endoscopic full-thickness gastroplication by the Plicator instrument has proven to be a safe and effective method to improve symptoms of gastroesophageal reflux disease. This is the first comparative objective data study for endoscopic versus laparoscopic antireflux procedures. STUDY: In this single-center controlled open trial in 70 adult patients with documented gastroesophageal reflux disease without hiatal hernias, objective and subjective outcome parameters were evaluated prospectively and compared. Patients were randomly assigned to either endoscopic full-thickness gastroplication or laparoscopic antireflux surgery. Patients in the Plicator group received between 1 and 3 transmural-pledgeted sutures to the gastric cardia. Patients in the laparoscopic anti-reflux surgery (LARS) group underwent Nissen or Toupet fundoplication. Esophageal manometry, 24-hour impedance pH monitoring, Gastrointestinal Quality-of-Life Index, and symptom questionnaires were evaluated at baseline and at the 3-month follow-up for significant (P<0.05) changes and differences. RESULTS: Lower esophageal sphincter pressures were increased in the LARS group and unchanged in the Plicator group. Total reflux numbers, acid, nonacid, proximal, upright, and recumbent reflux events were reduced in both groups, significantly more in the LARS group. Reductions in reflux-related esophageal acid scores were significant only in the LARS group. Similar improvements of Gastrointestinal Quality-of-Life Index were found in both groups. General and gas-related symptom scores were comparably reduced. Greater Reductions in reflux-specific symptom scores were found after LARS. Bowel dysfunction symptom scores were lower after LARS. CONCLUSIONS: Improvements in the general subjective outcome parameters were similar after endoscopic full-thickness gastroplication compared with LARS despite a stronger reflux control provided by LARS. More effective relief of reflux-related symptoms favors LARS, and differences in side effect symptoms favor endoscopic full-thickness gastroplication.

Laparoscopic Nissen versus Toupet fundoplication: objective and subjective results of a prospective randomized trial.

BACKGROUND: Although symptom outcomes following laparoscopic fundoplication have been adequately evaluated in the past, comparative subjective data of laparoscopic Nissen and Toupet fundoplications are scarce. Multichannel intraluminal impedance monitoring (MII) has not been used so far for comparison of objective data. METHODS: One hundred patients with documented chronic gastroesophageal reflux disease (GERD) were randomly allocated to either floppy Nissen fundoplication (group I, n = 50) or Toupet fundoplication (group II, n = 50). Gastrointestinal Quality of Life Index (GIQLI), symptom grading, esophageal manometry, and MII data were documented preoperatively and 3 months after surgery. Subjective and objective outcome data were compared to those of healthy individuals. RESULTS: Symptom intensity was significantly more severe and GIQLI showed impairment in the examined patient population compared to healthy controls. Both procedures resulted in a significant improvement in GIQLI and GERD symptoms (p < 0.01). Dysphagia improved significantly only in group II, while cough, asthma, and distortion of taste improved significantly in both groups. Hoarseness symptoms showed some degree of improvement in both groups but reached statistical significance only in group I. Postoperatively, bowel symptoms partly increased and the ability to belch decreased in both groups (p < 0.05). Comparison of postoperative GIQLI and symptom scores showed no significant difference between the two groups, except for the ability to belch, which was more impaired after Nissen fundoplication. Both procedures resulted in a significant improvement in lower esophageal sphincter (LES) pressure; however, the improvement was greater in group I than in group II. MII data showed more reflux control after Nissen, but the differences between the procedures were not significant. CONCLUSIONS: Both procedures equally improve quality of life and GERD symptoms. Bowel symptoms may increase after both procedures at the 3-month follow-up. Manometry and MII data favor Nissen fundoplication, but dysphagia and the inability to belch are more common compared to Toupet fundoplication.

Laparoscopic Nissen fundoplication with prosthetic hiatal closure reduces postoperative intrathoracic wrap herniation: preliminary results of a prospective randomized functional and clinical study.

BACKGROUND: Postoperative intrathoracic wrap migration is the most frequent morphological complication after laparoscopic antireflux surgery. Previous authors have studied the use of prosthetic materials for hiatal closure to prevent recurrence of hiatal hernia and/or postoperative intrathoracic wrap herniation. HYPOTHESIS: Patients with prosthetic hiatal closure have a higher rate of short-term dysphagia but a significantly lower rate of postoperative intrathoracic wrap herniation at follow-up. DESIGN: Prospective randomized trial. We compared patients who underwent laparoscopic Nissen fundoplication with simple sutured hiatoplasty with those who underwent laparoscopic Nissen fundoplication with prosthetic hiatal closure. SETTING: University-affiliated community hospital. PATIENTS: One hundred consecutive patients undergoing laparoscopic Nissen fundoplication for gastroesophageal reflux disease and hiatal hernia repair. INTERVENTION: Laparoscopic Nissen fundoplication with simple sutured crural closure (n = 50 [group 1]) vs laparoscopic Nissen fundoplication with simple sutured cruroplasty and onlay of a polypropylene mesh (n = 50 [group 2]). MAIN OUTCOME MEASURES: Recurrences; complications; results of esophageal manometry, 24-hour pH monitoring, esophagogastroduodenoscopy, and barium swallow test; and symptomatic outcome. RESULTS: Patients in both groups had similar preoperative values in esophageal manometry, 24-hour pH monitoring, and symptom scoring. At the 3-month and 1-year follow-ups, functional outcome variables (lower esophageal sphincter pressure and DeMeester score) improved significantly compared with the preoperative values. A higher postoperative dysphagia rate could be evaluated in group 2. An intrathoracic wrap migration occurred in 13 patients (26%) in group 1 vs 4 (8%) in group 2 (P<.001). CONCLUSION: Laparoscopic Nissen fundoplication with prosthetic cruroplasty is an effective procedure to reduce the incidence of postoperative hiatal hernia recurrence and intrathoracic wrap herniation.