Hiatal Hernia Repair With Tension-Free Mesh or Crural Sutures Alone in Antireflux Surgery

Abstract

ImportanceAntireflux surgery is an effective treatment of gastroesophageal reflux disease (GERD), but the durability of concomitant hiatal hernia repair remains challenging. Previous research reported that the use of a mesh-reinforced, tension-free technique was associated with more dysphagia for solid foods after 3 years without reducing hiatal hernia recurrence rates compared with crural sutures alone, but the long-term effects of this technique have not been assessed.ObjectiveTo assess the long-term anatomical and functional outcomes of using a mesh for hiatal hernia repair in patients with GERD.Design, Setting, and ParticipantsA double-blind, randomized clinical trial was performed at a single center (Ersta Hospital, Stockholm, Sweden) from January 11, 2006, to December 1, 2010. A total of 159 patients were recruited and randomly assigned. Data for the current analysis were collected from September 1, 2021, to March 31, 2022. All analyses were conducted with the intention-to-treat population.InterventionsClosure of the diaphragmatic hiatus with crural sutures alone vs a tension-free technique using a nonabsorbable polytetrafluoroethylene mesh (Bard CruraSoft).Main Outcomes and MeasuresThe primary outcome was radiologically verified recurrent hiatal hernia after more than 10 years. Secondary outcomes were dysphagia scores (ranging from 1 to 4, with 1 indicating no episodes of dysphagia and 4 indicating more than 3 episodes of dysphagia per day) for solid and liquid foods, generic 36-Item Short Form Health Survey and disease-specific Gastrointestinal Symptom Rating Scale symptom assessment scores, proton pump inhibitor consumption, and reoperation rates. Intergroup comparisons of parametric data were performed using t tests; for nonparametric data, Mann-Whitney U, χ2, or Fisher exact tests were used. For intragroup comparisons vs the baseline at follow-up times, the Friedman test was used, and post hoc analysis was performed using Wilcoxon matched pairs.ResultsOf 145 available patients, follow-up data were obtained from 103 (response rate 71%; mean [SD] age at follow-up, 65 [11.3] years; 55 [53%] female), with 53 initially randomly assigned to mesh reinforcement, and 50 to crural suture alone. The mean (SD) follow-up time was 13 (1.1) years. The verified radiologic hiatal hernia recurrence rates were 11 of 29 (38%) in the mesh group vs 11 of 35 (31%) in the suture group (P = .61). However, 13 years postoperatively, mean (SD) dysphagia scores for solids remained significantly higher in the mesh group (mean [SD], 1.9 [0.7] vs 1.6 [0.9]; P = .01).Conclusions and RelevanceFindings from this long-term follow-up of a randomized clinical trial suggest that tension-free crural repair with nonabsorbable mesh does not reduce the incidence of hiatal hernia recurrence 13 years postoperatively. This finding combined with maintained higher dysphagia scores does not support the routine use of tension-free polytetrafluoroethylene mesh closure in laparoscopic hiatal hernia repair for treatment of GERD.Trial RegistrationClinicalTrials.gov Identifier: NCT05069493

IDEAL Phase 2a Results

“…Despite the availability of numerous techniques and prosthetic materials, recurrence rates have not changed in decades. 2,3,14,15 Furthermore, due to complications of placing prosthetic material around the esophagus, 16,17 most surgeons have abandoned the use of these materials and perform a standard cruroplasty instead for large PEHs with a fundoplication. 14 Yet standard cruroplasty portends a high fatigue rate and is assumed to be due to the size of the hernia, attenuation of the tissues and the subsequent tension on the muscular crural pillars during a repair.…”

“…Although highly experienced surgeons are heavily invested in these complex and time-intensive repairs, recurrence still occurs in almost 50% of cases. Despite the availability of numerous techniques and prosthetic materials, recurrence rates have not changed in decades 2,3,14,15 . Furthermore, due to complications of placing prosthetic material around the esophagus, 16,17 most surgeons have abandoned the use of these materials and perform a standard cruroplasty instead for large PEHs with a fundoplication 14 …”

“…Current surgical approaches, with or without prosthetic material, anticipate a recurrence rate of at least 40% to 50% at 5 years, even among skilled surgeons. [1][2][3] In fact, despite the availability and failed success of both absorbable and permanent mesh, primary repair of the hiatus remains the mainstay of surgical treatment for PEH. Challenges with PEH repair are multifactorial and include primary closure of weakened crural muscle in a large attenuated diaphragmatic defect; the absence of a substantial fascial layer to use to close the defect; and the avoidance of permanent mesh due to the risk of shrinkage, dysphagia and esophageal erosion.…”

“…Surgery in such patients involves extensive mediastinal dissection to reduce the large hernia sac, repositioning of the gastroesophageal junction into the abdomen, and then repair of a significantly attenuated defect in older patients with attenuated diaphragmatic muscle integrity. Current surgical approaches, with or without prosthetic material, anticipate a recurrence rate of at least 40% to 50% at 5 years, even among skilled surgeons 1–3 . In fact, despite the availability and failed success of both absorbable and permanent mesh, primary repair of the hiatus remains the mainstay of surgical treatment for PEH.…”

Mesh and Hiatal Hernia Repair—The Never-Ending Saga

“…In the present study 1 with follow-up of more than 10 years, the authors were able to interview 103 (53 PTFE group and 50 suture-alone group) of the original 159 patients (65%). 2 Hernia recurrence was evaluated at 13 years by computed tomography scan in 64 patients (40%), 29 in the PTFE group and 35 in the suture group. Hernia recurrence was detected in 38% and 31% of the individuals in the PTFE and suture groups, respectively.…”