Patients
A total of consecutive 230 patients diagnosed with GERD and underging TF (n = 142) and SRF (n = 88) at our hospital between January 2014 and June, 2017 were enrolled in the retrospective study. GERD was diagnosed by endoscopy showing esophagitis or abnormal esophageal pH, a DeMeester score ≥ 14.7 with symptom correlation of ≥50%, and/or > 73 reflux episodes during 24-h ambulatory impedance monitoring period, lower than normal LES pressure by esophageal manometry. They were endoscopically confirmed to have Los Angeles grade A or B esophagitis, with non-hiatal hernia or small (< 2 cm) hiatal hernia. Patients were included if they were 18 years old or older, had clinical symptoms such as regurgitation, retrosternal pain and heartburn. Patients were excluded if they had diseases in the central nervous system or connective tissue, were previously performed esophageal or gastric surgery. Patients with esophageal stricture, shortened esophagus, impaired distal esophageal peristalsis, autoimmune diseases, collagen vascular diseases, Barrett’s esophagus, coagulation disorders, acute heart failure, cardiogenic shock and other important organ diseases and previous thoracic surgery were also excluded. Patients who had medications that affect the secretion of gastric acid and gastrointestinal motility within 7 days were also excluded to avoid the impact of the medication on evaluation of the therapeutic effect.
Patient demographics and clinical data at the time of diagnosis, including age, gender, duration of typical GERD symptoms prior to diagnosis, past and present medications, dietary inhibits, smoking, and clinical symptoms of typical GERD, were collected.
The study protocols were approved by the Ethical Review Committee of Hebei Medical University (Approval no HMU-2212, Nov, 2013) and conform to the ethical guidelines of the 1975 Declaration of Helsinki. Written consent was obtained from each patient included in the study.
Treatment
TF was performed under general anesthesia. The type of TF was either all laparoscopic or open or mix. After laparotomy, the abdominal esophagus was isolated. The left and right cruses of diaphragm were sutured for 1–2 sutures to close the esophageal hiatus. One cm gap was left between the top first suture and the esophagus to allow the patency of esophagus. Then, the gastric fundus was folded at 270 degrees and fixed with 2–3 sutures at the gastric fundus and on both sides of esophagus.
For SRF, the procedure was performed according to Triadafilopoulos [19]. Briefly, during a deeply sedated esophagogastroduodenoscopy (EGD), the eligibility was confirmed and the distance of the squamo-columnar junction (used as the approximate location for the gastroesophageal junction) was measured. A guide wire was introduced to the duodenum through the EGD, and the EGD was then withdrawn. A RF delivery catheter (Kanglian Medical Equipment Co., Ltd., Beijing) from a radiofrequency device (S500L, CURON MEDICAL Inc., USA) was inserted orally using the guide wire. The Stretta catheter is made up with an inflatable and flexible balloon-basket with four electrode needles. The balloon was inflated when it was 2 cm proximal to the squamo-columnar junction to deploy the electrode needles (22-gauge, 5.5-mm length). RF energy was delivered for 60 s. The needles were then withdrawn. After the balloon was deflated, and the catheter was rotated 45° to delivery radiofrequency. This process is repeated every 0.5 cm to cover the area 2 cm above and 1.5 cm below the squamo-columnar junction and six sets below the cardias for a total of 14 sets of needle deployments.
Outcome assessment
Reflux time and frequency, the DeMeester score, LES pressure, esophageal pH and prognosis were recorded, measured and analyzed. GERD relapse was the primary endpoint. The DeMeester score was measured as described previously [20]. A DeMeester score of > 14.7 was regarded as having reflux. LES pressure was measured using XDJ-S8S Esophageal Motility System (Kelly Photoelectrics Technology Co., Ltd., Hefei, China) according to the manufacturer’s instructions. Medications such as anti-cholinesterase drugs and acid-suppressing agents that may affect esophageal motor function and secretion of gastric acid were discontinued 7 days before the assessment. Patients were fasting for 4 to 6 h before the pressure measurement. Esophageal pH was measured using Digitrapper pH-Z Recorder with combined pH-Impedance (Given Imaging Ltd., USA) by inserting calibrated pH electrodes from the nasal cavity to 5 cm above LES. The esophageal pH at three meals, standing position and lying position was recorded for 24 h to calculate the DeMeester score. If the pH was < 4 and DeMeester score was greater than 14.72, it was regarded as acid reflux. The outcome was classified as good or poor prognosis. The poor prognosis included events such as dysphagia, abdominal distention, diarrhea, chronic stomach pain and recurrence of GERD. The patients were followed up for 1 year at 2 month intervals.
Statistical analysis
Data were analyzed with SPSS 17.0 software (SPSS Inc., Chicago, IL, United States) and were presented as the mean ± SD for continuous variables and as percentages and proportions for categorical variables. For the statistical analyses, the Kolmogorov-Smirnov test was used to assess the normality data. Independent t-test was applied to compare the means between two groups. Two-factor repeated measures ANOVA was used to compares the means between repeated measurement data. Counting data were expressed as percentage and tested using X2 test or the Fisher’s exact probability method. The stepwise Cox regression procedures were used to analyze the risk factors affecting prognosis. A value of P value < 0.05 was considered statistically significant.
