| 1. |
- Analatos, Apostolos, et al.
(författare)
-
Hiatal Hernia Repair With Tension-Free Mesh or Crural Sutures Alone in Antireflux Surgery A 13-Year Follow-Up of a Randomized Clinical Trial
- 2024
-
Ingår i: JAMA Surgery. - : American Medical Association (AMA). - 2168-6254 .- 2168-6262. ; 159:1, s. 11-18
-
Tidskriftsartikel (refereegranskat)abstract
- Importance Antireflux 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.Objective To assess the long-term anatomical and functional outcomes of using a mesh for hiatal hernia repair in patients with GERD.Design, Setting, and Participants A 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.Interventions Closure of the diaphragmatic hiatus with crural sutures alone vs a tension-free technique using a nonabsorbable polytetrafluoroethylene mesh (Bard CruraSoft).Main Outcomes and Measures The 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, chi(2), 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.Results Of 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 Relevance Findings 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 Registration ClinicalTrials.gov Identifier: NCT05069493
|
|
| 3. |
- Håkanson, Bengt S, et al.
(författare)
-
Comparison of wireless 48-h (Bravo) versus traditional ambulatory 24-h esophageal pH monitoring
- 2009
-
Ingår i: Scandinavian journal of gastroenterology. - Oslo, Norway : Taylor & Francis. - 1502-7708 .- 0036-5521. ; 44:3, s. 276-83
-
Tidskriftsartikel (refereegranskat)abstract
- Objective: To compare wireless with catheter-based esophageal pH recordings.Material and methods: Forty-five patients with symptoms suggestive of gastroesophageal reflux disease and 47 healthy volunteers were investigated in a university-affiliated hospital; 48-h wireless esophageal pH recording was performed. During the first 24 h, simultaneous traditional pH recording by catheter was undertaken. Nine of the volunteers underwent repeated measurements with both techniques. Outcome measures were feasibility, agreement, concordance of diagnostic yield, reproducibility, and subjective symptoms.Results: Subjective parameters were less affected when using the wireless technique alone (p<0.05). On using the wireless technique, esophageal acid exposure was underestimated approximately by half compared with traditional recording (p<0.05). Although pH data obtained with the two techniques were correlated (r(2)=0.66, p<0.001), the range between limits of agreement was wide (-3.7 to 10.0 percentage units of total time pH <4). Coefficients of variation for repeated measurements were 60.1+/-26.3% for catheter recordings, and 66.0+/-47.3 for wireless recordings on day 1 (NS). Concordance of diagnostic yield was 81.5% with all subjects included.Conclusions: Forty-eight-hour wireless Bravo pH monitoring is feasible but consistently underestimates esophageal acid exposure compared to the conventional technique. Although there is a significant correlation between the two techniques for pH recordings, the wide range in limits of agreement and the large coefficient of variation with both techniques suggest that the two methods are not immediately interchangeable for use in clinical practice.
|
|
