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Dor Versus Toupet Fundoplication After Laparoscopic Heller Myotomy: First Report From a Randomized Trial Including High Resolution Manometry Evaluation
Gonzalo Torres-Villalobos2, Luis a. Martin-Del-Campo*1, Athenea Flores-Najera2, Abraham Villa-BañOs2, Alejandro E. Svarch2, Enrique Coss-Adame3, Miguel a. Valdovinos3
1Department of Surgery, Instituto Nacional de Ciencias Medicas y Nutricion "Salvador Zubiran", Tlalpan, Mexico; 2Experimental Surgery Department, Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán", Tlalpan, Mexico; 3Department of Gastroenterology, Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán", Tlalpan, Mexico
Introduction Laparoscopic Heller myotomy is the best treatment for most patients with primary esophageal achalasia. Given the high rates of gastro-esophageal reflux after myotomy, an antireflux procedure must be performed in every case. Partial fundoplications are preferred given the high frequency of dysphagia associated with 360° wraps. To date, there is no data that allows the surgeon to choose between the posterior 270° (Toupet) or the anterior 180° (Dor) fundoplications. Objective To prospectively identify which partial fundoplication leads to a lower esophageal acid exposure and a better post-operative symptom profile. A high resolution manometry (HRM) evaluation of the lower esophageal sphincter (LES) for both procedures will also be performed. Methods After approval from our institution's ethics committee, adult patients with a HRM esophageal achalasia diagnosis were included. Patients were randomized to a Heller myotomy plus a Toupet or a Dor fundoplication. Pre-operative clinical data (including GERD-HRQL, EAT and Eckardt questionnaires scores), barium swallow and HRM were obtained. Post-operative follow-up included clinical evaluation, HRM and 24 hours pH-metry. Data are presented as means, standard deviations and ranges. For group comparison, categorical variables were analyzed using the squared-chi test. For numerical variables, the Student's t-test or the Mann-Whitney U test were used according to data distribution. SPSS v17.0 was used for analysis. Results To date, we have randomized 31 patients; 14 in the Toupet group and 17 in the Dor group. Both fundoplication groups were similar at baseline (Table 1). After a mean follow-up of 15 months (up to 25 months), we found no differences in GERD-HRQL, EAT or Eckardt scores between surgical groups (Table 2). Although DeMeester score seemed lower for the Dor group (5.0±7.2 vs. 11.5±12.6), this was not statistically significant (p=0.116). HRM performed 6 months after surgery showed no differences for lower esophageal sphincter resting pressure (12.8±4.7 vs 14.7±6.6; p=.418),or integrated relaxation pressure(7.8±3.1 vs 10.1±3.7; p=.113) for the Toupet and Dor groups respectively. Conclusion So far, we have not found objective or subjective differences between Dor and Toupet fundoplication after laparoscopic Heller myotomy. Further clinical follow-up may help clarify which antireflux procedure is best for these patients. Table 1. Pre-operative patient characteristics Variable | Toupet group | Dor group | p | Female gender | 9/14 (64%) | 12/17 (70%) | .709* | Age (years) | 41.42 (±12.94) | 45.41 (±16.17) | .462** | HRM Achalasia type Type I Type II Type III | . 2 11 1 | . 4 11 2 | .699* | Months from symptoms began to surgery | 41.14 (±31.22) | 31.64 (±22.32) | .332** | Pre-operative dysphagia | 13/14 (92%) | 17/17 (100%) | .263* | Regurgitation | 13/14 (92%) | 15/17 (88%) | .665* | Pyrosis | 8/14 (57%) | 11/17 (64%) | .667* | Kilograms lost | 13.50 (±15.78) | 11.94 (±8.07) | .509*** | Dilations performed | .85 (±1.87) | .70 (±.98) | .637*** | Preoperative barium swallow -Stenosis -Esophageal dilation -Sigmoid esophagus | . 2 11 1 | . 2 10 5 | .294* | Preoperative GERD HRQL score | 25.35 (±14.70) | 28.58 (±14.18) | .540** | Preoperative EAT score | 32.28 (±7.47) | 33.05 (±7.28) | .773** | Preoperative Eckardt score | 10.71 (±5.20) | 9.88 (±1.45) | .544*** | Preoperative LES resting pressure | 37.63 (±17.06) | 42.54 (±35.58) | .654** | Preoperative IRP | 26.85 (±8.72) | 26.62 (±18.81) | .972** | | | | | | | | |
*Chi-square **Students t-test ***Mann-Whitney U Table 2. Post-operative clinical evaluation Variable | Toupet | Dor | p | GERDHRQL score 1 month 6 months Last follow-up | . 4.42 (±6.32) 9.78 (±11.45) 5.21 (±8.98) | . 3.94 (±4.60) 6.86 (±8.62) 5.33 (±7.29) | . .952*** .443** .780*** | EAT score 1 month 6 months Last follow-up | . 3.71 (±4.63) 4.92 (±6.87) 3.21 (7.61) | . 3.05 (±4.27) 5.06 (±9.55) 1.20 (±2.24) | . .686** .780*** .505*** | Eckardt score 1 month 6 months Last follow-up | . 1.78 (±1.84) 1.71 (±1.81) 1.42 (±1.82) | . 1.76 (±1.98) 1.93 (±2.60) 1.00 (±1.13) | . .976** .914*** .451** |
**Student t-test ***Mann-Whitney U
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