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A Sleep Positioning Device for Refractory Gastroesophageal Reflux in Scleroderma
Su1067
AGA Abstracts
A SLEEP POSITIONING DEVICE FOR REFRACTORY GASTROESOPHAGEAL REFLUX IN SCLERODERMA Rena H. Yadlapati, Jenna Craft, Amanda B. Siegel, Olga Alexeeva, Darren M. Brenner, John E. Pandolfino Introduction: Patient with scleroderma often suffer from refractory gastroesophageal reflux disease (GERD). The MedCline® Sleep Positioning Device (SPD) is reported to reduce nocturnal heartburn and regurgitation. The aim of this study was to assess the therapeutic efficacy of the SPD in scleroderma patients with refractory GERD symptoms. Methods: We are performing a prospective double pre-test, post-test pilot clinical trial at a single tertiary care center. Data presented is an interim analysis over a 6-month period (3/16-9/16). Patients with a diagnosis of scleroderma on anti-secretory medications and GerdQ scores > 8 were recruited. Patients were followed over two weeks: one week without SPD use and one week with SPD use. Data points were collected at Day 0 (baseline/pre-SPD), Day 7 (pre-SPD), and Day 15 (post-SPD). At each data point subjects completed the GerdQ and Nocturnal GERD Symptom Severity & Impact Questionnaire (N-GSSIQ), and provided a sputum sample for salivary pepsin concentration analysis. The primary outcome was change in NGSSIQ score, with a primary endpoint of 50% reduction in N-GSSIQ score. Results: Of 11 recruited patients, 1 was lost to follow-up, 1 died, 1 is currently enrolled and 8 patients completed the study. Data is presented for the 8 subjects that completed the study. Mean subject age was 48.8 ± 9.2 years and 7 (88%) were female. There were no significant differences between the two pre-test data points for GerdQ, N-GSSIQ, or salivary pepsin concentrations. After 1 week use of the SPD, 2 (25%) subjects achieved the primary endpoint. Four (50%) had an overall (baseline to post-SPD) reduction in GerdQ and 6 (75%) had an overall reduction in N-GSSIQ. Mean GerdQ scores significantly decreased from baseline to post-SPD (9.8 ± 2.0 vs 7.8 ± 1.8, p = 0.05). Mean post-SPD N-GSSIQ scores were lower than pre-SPD, but this did not reach statistical significance. Salivary pepsin concentrations remained elevated throughout the study period without any significant changes (Table 1/ Figure 1). Discussion: While a minority of scleroderma patients achieved the primary endpoint, the majority reported symptom relief in overall and nocturnal GERD symptoms after using the SPD for one week. Prior studies have reported no adverse events and good tolerability with the SPD. The SPD may be an option for scleroderma patients with refractory GERD symptoms. Changes in symptom score and pepsin concentration throughout the double pre-test, posttest study.
Sleep Positioning Device (SPD); Nocturnal GERD Symptom Severity & Impact Questionnaire (N-GSSIQ). Data presented as Mean (SD).
Su1068 PREDICTORS OF PERSISTENT GASTROESOPHAGEAL REFLUX SYMPTOMS AFTER FUNDOPLICATION Zubin Arora, Sampurna Shakya, Thomas W. Rice, Rocio Lopez, Prashanthi N. Thota Background: Fundoplication is a commonly performed surgical procedure for treatment of symptomatic hiatal hernias and gastroesophageal reflux disease (GERD) symptoms poorly responsive to medical therapy. Some patients continue to have symptoms even after a successful fundoplication. Our aim is to determine the factors which predict persistent symptoms in patients who go through fundoplication. Methods: This is a retrospective analysis of all patients who underwent fundoplication at our institution between January 1st 2006 to and December 31 st 2013 by a single thoracic surgeon (TWR). Patients with information available regarding both pre- and post-fundoplication symptoms were included in the study. Symptom resolution was defined as absence of heartburn, chest pain and regurgitation after fundoplication. Presence of any of the three symptoms after fundoplication was considered as persistent symptoms. Demographic data, symptoms, indication and type of hiatal hernia repair, high resolution esophageal manometry (HREM) findings, esophageal pH test results and upper endoscopic findings were recorded. Results: A total of 276 patients were included in the analysis. Mean age was 59.6±13.6 years and 198 (71.1%) were female. Indication for fundoplication was paraesophageal hernia 131/276 (47.4%) and prior failed fundoplication in 53 patients (38.1%). Two hundred and twenty (81.1%) patients also underwent a simultaneous Collis gastroplasty. Overall, 244 (83.3%) of patients reported symptom resolution. Table 1 presents the univariable analysis of factors associated with persistent symptoms. Patients with persistent symptoms were younger (54.3±15.5 vs. 59.2±12.8 years, p= 0.047), more likely to have esophagitis on preoperative upper endoscopy (21.9% vs. 10%, p=0.047) and had a longer duration of follow up (32.5 months vs. 12 months, p=0.004) as compared to those with symptom resolution. There was no difference in the indication for surgery, the type of repair and preoperative HREM findings and pH testing between the two groups. Conclusions: Our data, from a selected cohort of patients
AGA Abstracts
S-462
AGA Abstracts
A SLEEP POSITIONING DEVICE FOR REFRACTORY GASTROESOPHAGEAL REFLUX IN SCLERODERMA Rena H. Yadlapati, Jenna Craft, Amanda B. Siegel, Olga Alexeeva, Darren M. Brenner, John E. Pandolfino Introduction: Patient with scleroderma often suffer from refractory gastroesophageal reflux disease (GERD). The MedCline® Sleep Positioning Device (SPD) is reported to reduce nocturnal heartburn and regurgitation. The aim of this study was to assess the therapeutic efficacy of the SPD in scleroderma patients with refractory GERD symptoms. Methods: We are performing a prospective double pre-test, post-test pilot clinical trial at a single tertiary care center. Data presented is an interim analysis over a 6-month period (3/16-9/16). Patients with a diagnosis of scleroderma on anti-secretory medications and GerdQ scores > 8 were recruited. Patients were followed over two weeks: one week without SPD use and one week with SPD use. Data points were collected at Day 0 (baseline/pre-SPD), Day 7 (pre-SPD), and Day 15 (post-SPD). At each data point subjects completed the GerdQ and Nocturnal GERD Symptom Severity & Impact Questionnaire (N-GSSIQ), and provided a sputum sample for salivary pepsin concentration analysis. The primary outcome was change in NGSSIQ score, with a primary endpoint of 50% reduction in N-GSSIQ score. Results: Of 11 recruited patients, 1 was lost to follow-up, 1 died, 1 is currently enrolled and 8 patients completed the study. Data is presented for the 8 subjects that completed the study. Mean subject age was 48.8 ± 9.2 years and 7 (88%) were female. There were no significant differences between the two pre-test data points for GerdQ, N-GSSIQ, or salivary pepsin concentrations. After 1 week use of the SPD, 2 (25%) subjects achieved the primary endpoint. Four (50%) had an overall (baseline to post-SPD) reduction in GerdQ and 6 (75%) had an overall reduction in N-GSSIQ. Mean GerdQ scores significantly decreased from baseline to post-SPD (9.8 ± 2.0 vs 7.8 ± 1.8, p = 0.05). Mean post-SPD N-GSSIQ scores were lower than pre-SPD, but this did not reach statistical significance. Salivary pepsin concentrations remained elevated throughout the study period without any significant changes (Table 1/ Figure 1). Discussion: While a minority of scleroderma patients achieved the primary endpoint, the majority reported symptom relief in overall and nocturnal GERD symptoms after using the SPD for one week. Prior studies have reported no adverse events and good tolerability with the SPD. The SPD may be an option for scleroderma patients with refractory GERD symptoms. Changes in symptom score and pepsin concentration throughout the double pre-test, posttest study.
Sleep Positioning Device (SPD); Nocturnal GERD Symptom Severity & Impact Questionnaire (N-GSSIQ). Data presented as Mean (SD).
Su1068 PREDICTORS OF PERSISTENT GASTROESOPHAGEAL REFLUX SYMPTOMS AFTER FUNDOPLICATION Zubin Arora, Sampurna Shakya, Thomas W. Rice, Rocio Lopez, Prashanthi N. Thota Background: Fundoplication is a commonly performed surgical procedure for treatment of symptomatic hiatal hernias and gastroesophageal reflux disease (GERD) symptoms poorly responsive to medical therapy. Some patients continue to have symptoms even after a successful fundoplication. Our aim is to determine the factors which predict persistent symptoms in patients who go through fundoplication. Methods: This is a retrospective analysis of all patients who underwent fundoplication at our institution between January 1st 2006 to and December 31 st 2013 by a single thoracic surgeon (TWR). Patients with information available regarding both pre- and post-fundoplication symptoms were included in the study. Symptom resolution was defined as absence of heartburn, chest pain and regurgitation after fundoplication. Presence of any of the three symptoms after fundoplication was considered as persistent symptoms. Demographic data, symptoms, indication and type of hiatal hernia repair, high resolution esophageal manometry (HREM) findings, esophageal pH test results and upper endoscopic findings were recorded. Results: A total of 276 patients were included in the analysis. Mean age was 59.6±13.6 years and 198 (71.1%) were female. Indication for fundoplication was paraesophageal hernia 131/276 (47.4%) and prior failed fundoplication in 53 patients (38.1%). Two hundred and twenty (81.1%) patients also underwent a simultaneous Collis gastroplasty. Overall, 244 (83.3%) of patients reported symptom resolution. Table 1 presents the univariable analysis of factors associated with persistent symptoms. Patients with persistent symptoms were younger (54.3±15.5 vs. 59.2±12.8 years, p= 0.047), more likely to have esophagitis on preoperative upper endoscopy (21.9% vs. 10%, p=0.047) and had a longer duration of follow up (32.5 months vs. 12 months, p=0.004) as compared to those with symptom resolution. There was no difference in the indication for surgery, the type of repair and preoperative HREM findings and pH testing between the two groups. Conclusions: Our data, from a selected cohort of patients
AGA Abstracts
S-462