Tension-free mesh versus suture-alone cruroplasty in antireflux surgery: a randomized, double-blind clinical trial.

BACKGROUND: Antireflux surgery is effective for the treatment of gastro-oesophageal reflux disease (GORD) but recurrence of hiatal hernia remains a challenge. In other types of hernia repair, use of mesh is associated with reduced recurrence rates. The aim of this study was to compare the use of mesh versus sutures alone for the repair of hiatal hernia in laparoscopic antireflux surgery. METHODS: Patients undergoing laparoscopic Nissen fundoplication for GORD between January 2006 and December 2010 were allocated randomly to closure of the diaphragmatic hiatus with crural sutures or non-absorbable polytetrafluoroethylene mesh (CruraSoft®). The primary outcome was recurrence of hiatal hernia, as determined by barium swallow study 12 months after surgery. Secondary outcomes were: intraoperative and postoperative complications, use of antireflux medication, postoperative oesophageal acid exposure, quality of life, dysphagia and duration of hospital stay. RESULTS: Some 77 patients were randomized to the suture technique and 82 patients underwent mesh repair. At 1 year, the hiatal hernia had recurred in six of 64 patients (9 per cent) in the mesh group and two of 64 (3 per cent) in the suture group (P = 0·144). Reflux symptoms, use of proton pump inhibitors and oesophageal acid exposure did not differ between the groups. At 3 years, recurrence rates were 13 and 10 per cent in the mesh and suture groups respectively (P = 0·692). Dysphagia scores decreased in both groups, but more patients had dysphagia for solid food after mesh closure (P = 0·013). Quality-of-life scores were comparable between the groups. CONCLUSION: Tension-free crural repair with non-absorbable mesh does not reduce the incidence of recurrent hiatal hernia compared with use of sutures alone in patients undergoing laparoscopic fundoplication. NCT03730233 ( http://www.clinicaltrials.gov).

ANTECEDENTES: La cirugía antirreflujo es efectiva para el tratamiento de la enfermedad por reflujo gastroesofágico (gastro-oesophageal reflux disease, GORD), pero la recidiva de la hernia de hiato sigue siendo un desafío. En otros tipos de reparación herniaria, la utilización de mallas se asocia con tasas reducidas de recidiva. El objetivo de este estudio fue comparar la utilización de una malla con suturas solo para la reparación de la hernia de hiato en cirugía antirreflujo laparoscópica. MÉTODOS: Pacientes sometidos a funduplicatura de Nissen por GORD entre enero 2006 y diciembre 2010 fueron asignados de forma aleatoria a cierre del hiato diafragmático con suturas de la crura o malla PTFE no absorbible (CruraSoft®). El resultado primario fue la recidiva de la hernia hiatal determinada mediante estudio radiológico con papilla de bario a los 12 meses de la cirugía. Los resultados secundarios fueron las complicaciones intra- y postoperatorias, utilización de medicación antirreflujo, exposición postoperatoria del esófago al reflujo ácido, calidad de vida, disfagia y duración de la estancia postoperatoria. RESULTADOS: Un total de 77 pacientes fueron aleatorizados a la técnica con suturas y 82 pacientes fueron sometidos a reparación con malla. Al año, se observó recidiva de la hernia de hiato en 6 de 64 pacientes en el grupo con malla (9%) y 2 de 64 pacientes (3%) en el grupo con suturas (P = 0,144). Los síntomas de reflujo, utilización de inhibidores de la bomba de protones (IBPs) y exposición del esófago al ácido no difirieron entre los grupos. A los 3 años, las tasas de recidiva fueron 13% y 10% para el grupo con malla y para el grupo con sutura, respectivamente (P = 0,692). Las puntuaciones de disfagia se redujeron en ambos grupos, pero más pacientes presentaron disfagia para sólidos tras el cierre con malla (P = 0,013). Las puntuaciones de calidad de vida posteriores fueron similares en ambos grupos. CONCLUSIÓN: En pacientes sometidos a funduplicatura laparoscópica, la reparación de la crura sin tensión con malla no absorbible no reduce la incidencia de recidiva de la hernia de hiato en comparación con el uso de suturas solo.

Open vs laparoscopic partial posterior fundoplication. A prospective randomized trial.

OBJECTIVE: This study compares outcomes following open and laparoscopic partial posterior fundoplication for gastroesophageal reflux disease concerning perioperative course, postoperative complications, symptomatic relief, recurrent disease, and the need for reinterventional surgery. METHODS: A prospective randomized trial was performed. Pre- and postoperative testing included endoscopy, esophageal function testing, patient questionnaire, and clinical assessment. Patients were followed for three years. MATERIALS: Ninety-three patients were randomized to open and 99 to laparoscopic surgery. RESULTS: Complication rates were higher, and length of stay (LOS) [5 (3-36) vs 3 (1-12) days] and time off work [42 (12-76) vs 28 (0-108) days] was longer in the open group (p < 0.01). Early side effects and recurrences were more common (p < 0.05) in the laparoscopic group. One patient in the open group and 8 patients in the laparoscopic group required surgery for recurrent disease and 7 patients required surgery for incisional hernias after open surgery. Overall, at one and three years, there were no differences in patient-assessed satisfactory outcome (93.5/93.5 vs 88.8/90.8%) or reflux control (p = 0.53) between the open and laparoscopic groups. CONCLUSIONS: The finding of fewer general complications, shorter length of stay and recovery, similar need for reoperations, and comparable 3-year outcomes, makes the laparoscopic approach the primary choice when considering surgical options for the treatment of gastroesophageal reflux disease (GERD).

Preoperative oesophageal motor activity does not predict postoperative dysphagia.

OBJECTIVE: To evaluate the ability of preoperative manometric examinations to predict temporary or permanent dysphagia after antireflux procedures. DESIGN: Retrospective study. SETTING: Teaching hospital, Sweden. SUBJECTS: 191 patients who had partial fundoplication. INTERVENTIONS: Stationary manometry with a perfused catheter system. MAIN OUTCOME MEASURES: Correlation between preoperative manometric examinations and the incidence of dysphagia before and after operation. RESULTS: 98 of 191 patients had dysphagia preoperatively (51%), but 52 of the 98 had no stricture or motor disorder to explain it; 25 of 59 patients with motor disorders shown manometrically (42%) did not complain of dysphagia. The number of patients with dysphagia was reduced to 43 postoperatively. 8 who did not complain of dysphagia preoperatively did so postoperatively; 4 of 8 had defective peristalsis and 4 had normal preoperative tracings. CONCLUSIONS: Manometric examination does not help us to understand the mechanism of preoperative dysphagia, nor does it predict who will develop dysphagia postoperatively.