Retrospective TIF Study for Treatment of Gastroesophageal Reflux Disease (GERD). The RetroTIF Study

Typical and atypical GERD symptom elimination in GERD Health-Related Quality of Life (GERD-HRQL). HRQL questionnaire measures typical GERD symptoms, scale 0-5 for each of 9 questions; scores considered normalized if every score is 0), GERD Symptom Score (GERSS measures atypical GERD symptoms, scale 0-3 for severity and 0-4 for frequency, with total scale 0-60; patients with controlled reflux symptoms are expected to have a score of \<18) and Reflux Symptom Index (RSI measures atypical laryngopharyngeal (LPR) symptoms, scale 0-5 for each of 9 questions with maximum of 45 with a normality threshold of \< or = 13) questionnaires) at the follow-up.

Time frame: median 7 months (range 5-17 months)

The treatment will be considered safe if the incidence of serious adverse events (SAEs) is below the ranges reported for laparoscopic fundoplication.

Time frame: median 7 months (range 5-17 months)

Population: There were no serious adverse events or UADE during the study.

Patients reporting complete discontinuation of daily PPI use will be considered clinically significant.

Time frame: median 7 months (range 5-17 months)

Measurement obtained by study investigator, under endoscopic visualization using cm markings on the endoscope. Outcome measure assesses if hiatal hernia that was present at baseline and reduced (size reduction to \< 1 cm is considered clinically significant) during TIF procedure, has remained reduced at the post-TIF follow up exam.

Time frame: median 7 months (range 5-17 months)

Population: 53 patients were assessed for esophagitis and presence of hiatal hernia at follow-up. Hiatal hernia was present at baseline and reduced during TIF procedure in 34 of the patients examined at follow-up. Hiatal hernia in 33 of 34 remained reduced at follow-up. Please note: there was one new case of hiatal hernia reported that had not been present at baseline.

One LA grade reduction will be considered clinically significant. LA grades are A, B, C, D, with A being the least severe esophagitis. No grade assigned is considered normal, i.e. no esophagitis reported.

Time frame: median 7 months (range 5-17 months)

Population: Of 53 patients examined at follow up for esophagitis or hiatal hernia status, 30 had reported esophagitis at baseline. Please note: there was 1 new case of esophagitis reported at follow-up, that had not been present at baseline.

Esophageal acid exposure will be measured objectively by 48-hour Bravo Potential of Hydrogen (pH) or 24-hour impedance/pH testing at the follow-up (where pH testing is available). Normalization of esophageal acid exposure will be defined by total time pH\< 4 for ≤ 6% of 24-hour or for ≤ 5.3% of 48-hour monitoring period. The number of reflux episodes of ≤ 44 per each 24-hour period will be considered normal.

Time frame: median 7 months (range 5-17 months)

Population: Note: neither 48-hour Bravo pH nor 24-hour impedance/pH testing was completed. pH testing was unavailable at the study sites. Study protocol noted that testing would be completed if available. In the absence of these testing tools, sites relied on detailed history, physical signs, symptom evaluation, barium swallow, and repeated esophagogastroduodenoscopy (EGD) with biopsy to make diagnosis. This continues to be the most commonly used method of GERD diagnosis among community physicians.