Using quality-of-life measurements to predict patient satisfaction outcomes for antireflux surgery

HYPOTHESIS: Preoperative quality-of-life measurement can predict which patients will be satisfied with surgical fundoplication in the treatment of gastroesophageal reflux disease (GERD). DESIGN: Review of a prospectively gathered database. SETTING: Tertiary referral center. PATIENTS: All patients underwent preoperative physiological testing by upper endoscopy, esophageal manometry, and 24-hour esophageal pH monitoring, and some had contrast radiography and gastric emptying scintigraphy. Patients were examined for symptoms and completed a symptom severity questionnaire (the GERD-Health-Related Quality of Life questionnaire) and a generic quality-of-life instrument (the 36-Item Short-Form Health Survey [SF-36]). Patients then underwent either open or laparoscopic fundoplication. MAIN OUTCOME MEASUREMENTS: Patients were contacted to assess satisfaction 2 months to 5 years postoperatively. They completed the GERD-Health-Related Quality of Life questionnaire and the SF-36. Patients were grouped into those satisfied and dissatisfied. RESULTS: Two hundred ninety patients were included. Median follow-up was 29 months. Thirty-four patients (12%) were dissatisfied with their surgical outcomes for any reason. The dissatisfied patients had statistically significantly worse scores preoperatively in 6 of the 8 domains of the SF-36 than satisfied patients. Dissatisfied patients had less symptomatic improvement. The satisfied patients had statistically significant improvement in 6 domains, whereas the dissatisfied patients had statistically significant worsening of scores in 2 domains. CONCLUSIONS: Quality-of-life measurements are frequently used as an outcome end point. This study shows that a generic quality-of-life instrument can preoperatively identify patients with GERD who are likely to be dissatisfied with antireflux surgery. Use of quality-of-life instruments as a predictive tool for surgical outcomes deserves further study.     

Quality of life and surgical outcomes following laparoscopic surgery for refractory gastroesophageal reflux disease in a regional hospital

Background

Gastroesophageal reflux disease (GERD) is a prevalent condition leading to poor quality of life (QOL) in patients with refractory symptoms. Laparoscopic antireflux (LAR) surgery has been shown to improve QOL, and I sought to examine the surgical and QOL outcomes associated with LAR surgery over a 3-year period at a regional hospital.

Methods

Patients were given GERD–health related quality of life (GERD-HRQL) and SF-36 questionnaires preoperatively, at 6 months and at 12 or more months after surgery. I collected data on demographic and clinical characteristics and surgical outcomes.

Results

Of the 342 patients referred for GERD or dysphagia, 26 received LAR surgery during the study period. All 26 patients had symptoms refractory to medications; 19 had atypical symptoms and 8 had some form of chronic pain syndrome (CPS). The mean duration of surgery was 125 minutes. There were no conversions, complications, 30-day readmissions or deaths. Three patients stayed 2 days in hospital and 23 stayed overnight. One patient required esophageal dilation for persistent dysphagia. Two patients resumed medication for recurrent symptoms and 24 remained medication free. There were significant improvements in GERD–HRQL scores in all patients. Patients with CPS had no improvements in SF-36 scores, whereas patients without CPS showed significant improvement.

Conclusion

Excellent surgical outcomes in LAR surgery can be obtained with careful patient selection at a nonacademic regional hospital. Although GERD-HRQL improved in all patients, patients with CPS showed no improvement in general health QOL scores after LAR surgery. Careful patient counselling should be employed when offering LAR surgery to patients with CPS.     

Comparison of patient-centered outcomes after laparoscopic Nissen fundoplication for gastroesophageal reflux disease or paraesophageal hernia

Background Patients undergoing laparoscopic Nissen fundoplication (LNF) with paraesophageal hernias (PEH) are not only older and less healthy than those with gastroesophageal reflux disease (GERD), but in addition the repair is more complicated. We evaluated whether outcomes relating to GERD symptoms and quality of life (QOL) were impacted by the presence of PEH. Methods Prospectively entered data from 149 patients (109 GERD and 40 PEH) were evaluated prior to and one year after LNF with standardized and validated symptoms scores. Scores for heartburn, dysphagia, disease-specific QOL (GERD-HRQL), and general health-related QOL (SF-12 physical and mental component scores) were compared between patients undergoing LNF for PEH or for GERD alone, at baseline and one year after surgery. p < 0.05 was considered statistically significant. Results Preoperative data for GERD-HRQL, heartburn, and dysphagia were available for 134 patients, with 96% one-year follow-up. SF-12 data were collected for 98 patients with 100% follow-up. PEH patients were older and had greater comorbidity. Preoperative GERD-HRQL and heartburn were significantly worse in the GERD group. One year after surgery, both GERD and PEH patients showed significant improvement in GERD-HRQL, heartburn and dysphagia scores, with no difference in any of these disease or symptom measures between the two study groups. Postoperative PCS and MCS scores showed improvement in GERD patients, while PEH patient scores remained at or below the population mean. Conclusions LNF is equally effective as an antireflux procedure in both GERD and PEH patients, prevents symptoms of reflux in PEH patients that have none preoperatively, and does not increase dysphagia in either group. Despite the increased complexity of the procedure, LNF provides an effective control of reflux symptoms in patients undergoing PEH repair. Supported by an unrestricted educational grant from Tyco Healthcare Canada     

Quality of life and patient satisfaction after laparoscopic antireflux surgery using the QOLARS questionnaire

Background Currently, evaluation of patient satisfaction and quality-of-life data to estimate the outcome of laparoscopic antireflux surgery is an important issue. This study aimed first to report the midterm results for the surgical management of gastroesophageal reflux disease (GERD) by laparoscopic fundoplication and to evaluate surgical outcome, including quality of life and patient satisfaction. The second aim was to determine whether preoperative quality-of-life measurement can predict which patients will be satisfied with antireflux surgery. Methods The current prospective study evaluated the outcome of the quality-of-life data for 41 patients (13 men and 28 women) who underwent laparoscopic fundoplication in the author’s department of surgery between 1 January 2002 and 31 May 2003. The mean age of the patients was 41 years. Quality of life was measured by using a new quality-of-life instrument (QOLARS) developed and validated by the author’s study group. The patients completed the QOLARS questionnaire before surgery, then 6 weeks, 1 year, and 3 years after surgery. Results Before surgery, all the patients had a poor quality of life. The general quality-of-life and heartburn scores improved significantly within 6 weeks after surgery and showed further improvement by the end of the first postoperative year, then remained stable 3 years after surgery. The patients who became completely free of reflux-related symptoms were divided into two groups according to their satisfaction with the operative result. The patients dissatisfied with surgery had significantly worse median preoparative scores in four domians (physical functioning, emotional functioning, sleep disturbance, constipation) than the patients satisfied with the procedure. Conclusions The findings show that QOLARS is a sensitive tool for assessing surgical outcome after laparoscopic antireflux surgery. The quality-of-life response closely follows the clinical outcome of surgical treatment, reflecting its side effects as well. This study suggests that a generic quality-of-life scale can preoperatively identify patients with GERD who are likely to be dissatisfied with antireflux surgery.     

Laparoscopic Gastric Bypass after Antireflux Surgery for the Treatment of Gastroesophageal Reflux in Morbidly Obese Patients: Initial Experience

Background: Laparoscopic Roux-en-Y gastric bypass (LRYGBP) has been proven effective against gastroesophageal reflux disease (GERD) in morbidly obese patients. We present our experience with revision of antireflux procedures to LRYGBP in obese patients with recurrent GERD, weight gain or a combination of both and discuss the indications and technical considerations involved. Methods: Between June 2000 and December 2003, 7 morbidly obese patients with a mean BMI of 37.5 kg/m² underwent revision of an antireflux procedure to LRYGBP by our group. Important steps of the revision include dissection of the diaphragmatic crura and gastroesophageal fat pad, reduction and repair of hiatal hernia, and complete take-down of the wrap to avoid stapling over the fundoplication which can create an obstructed, septated pouch. Results: Mean operative time was 6 hr 12 min and length of stay was 4.8 days. There were 3 major complications postoperatively and no deaths. During follow-up, 5 patients developed anastomotic strictures and 2 patients were re-explored for gastric remnant herniation and intestinal obstruction. At a mean follow-up of 24 (3-44) months, mean excess weight loss was 70.7% and 14/20 (70%) co-morbid conditions were improved or resolved. GERD evaluation with the GERD-HRQL scale showed a significant reduction of GERD scores postoperatively (P =0.006). Conclusions: Although LRYGBP after antireflux surgery is a technically more difficult procedure with a higher morbidity, it is feasible and effective for the treatment of recurrent GERD and worsening obesity with the additional advantage of weight loss and improvement of co-morbidities.     

Long-term evaluation of patient satisfaction and reflux symptoms after laparoscopic fundoplication with Collis gastroplasty

Background Esophageal shortening is a complication of advanced gastroesophageal reflux disease (GERD). For patients with short esophagus, Collis gastroplasty combined with fundoplication provides excellent symptomatic relief from GERD disease. The literature lacks studies comparing satisfaction and reflux symptoms between patients who underwent Nissen fundoplication with Collis gastroplasty and those who had primary fundoplication alone. This study aimed to assess long-term satisfaction and GERD-related quality of life after laparoscopic Collis–Nissen fundoplication, and to compare them with those for Nissen fundoplication alone. Methods A nested case–control study was conducted. In this study, 14 cases of laparoscopic Collis–Nissen fundoplications were matched for age, gender, and length of the follow-up period to a cohort of 120 control subjects who underwent laparoscopic Nissen fundoplication. All the patients were mailed a follow-up survey which included a Short Form-12 (SF-12) health status (quality-of-life) questionnaire (a validated quality-of-life instrument), a Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire (a GERD-specific quality-of-life instrument), and queries regarding long-term satisfaction and medication use. Results Both groups showed a significant postoperative increase in QOLRAD mean scores (p = 0.01). However, the difference in the delta (postoperative–preoperative) score between the two groups was not significant (Fig. 1). There were no differences in mental (MCS) or physical (PCS) SF-12 scores between the two groups. The rate of satisfaction with the surgery was similar in the Nissen–Collis fundoplication (87.5%) and Nissen fundoplication (87%) groups. Fig. 1 Quality of Life in Reflux and Dyspepsia (QOLRAD) score in the two groups. (* p = 0.01 vs preoperative value)

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Conclusions Collis gastroplasty combined with Nissen fundoplication is an effective procedure for patients with a shortened esophagus diagnosed intraoperatively during antireflux surgery. Patient satisfaction, postoperative quality of life, and QOLRAD score improvement after this procedure are comparable with those observed in patients treated with Nissen fundoplication alone.     

Effects of manometrically discovered nonspecific motility disorders of the esophagus on the outcomes of antireflux surgery

Nonspecific motility disorders (NMDs) of the esophagus are common manometric findings in patients evaluated for gastroesophageal reflux disease (GERD). However, it is unclear how these disorders affect the outcomes of antireflux surgery. The purpose of this study was to assess symptomatic outcomes of patients with and without NMDs undergoing surgical treatment for GERD. A prospectively gathered database of all patients undergoing antireflux surgery was retrospectively reviewed for preoperative symptoms, symptom severity using the GERD-HRQL (best score 0, worst score 50), esophageal manometry measurements, presence of NMD, type of operation, any transient or permanent postoperative dysphagia, severity of postoperative dysphagia (best score 0, worst score 5), and postoperative symptom severity. A total of 239 patients were studied; 24% had a NMD identified by preoperative esophageal manometry, and 17% of this +NMD group had preoperative dysphagia or atypical chest/epigastric pain compared to 28% of those without a NMD (-NMD group) (P=NS). Preoperative symptom scores were +NMD 33 vs. -NMD 27 (P=0.01). Postoperative symptom scores were +NMD 5 vs. -NMD 3 (P=NS). There were no differences in preoperative or postoperative dysphagia scores. Transient postoperative dysphagia was 15.8% in the +NMD group vs. 16.4% in the -NMD group (P=NS). Postoperative dilation was 0% in the +NMD group vs. 2% in the -NMD group (P=NS). Manometrically discovered NMDs do not appear to affect preoperative symptoms or symptomatic outcomes of patients surgically treated for GERD. These findings my reflect the severity of GERD and may improve with antireflux surgery.     

Endoscopic full-thickness plication for the treatment of GERD: Five-year long-term multicenter results

Background The Plicator™ (NDO Surgical, Inc., Mansfield, MA) endoscopically places a full-thickness permanent suture to augment the antireflux barrier. At 3-years post-treatment, published results demonstrated a reduction in subjects’ gastroesophageal reflux disease (GERD) symptoms and related medication use. Aim To evaluate the Plicator’s safety and durability of effect at improving GERD symptoms at 5-years post-treatment. Methods A total of 33 chronic GERD sufferers across seven sites were followed for approximately 5 years (median follow-up: 59 months, range 50–65 months) after receiving a single full-thickness plication approximately 1 cm below the gastroesophageal (GE) junction in the anterior gastric cardia. At baseline, 30 out of 33 subjects required daily proton-pump inhibitor (PPI) therapy. Results Of the subjects who were PPI dependent prior to treatment 67% (20/30) remained off daily PPI therapy at 60 months and 5-year median GERD health-related quality-of-life (HRQL) scores show significant improvement from baseline off-meds scores (10 versus 19, p < 0.001). Additionally, 50% (16/32) of subjects achieved ≥ 50% score improvement in GERD-HRQL. No new adverse events were identified and all device-related events occurred acutely. These results were comparable to the results seen at 36 months follow-up. Conclusions Endoscopic full-thickness plication can reduce GERD symptoms and medication use for at least 5-years post procedure with no long-term adverse events post treatment.     

Assessment of Quality of Life after Laparoscopic Nissen Fundoplication in Patients with Gastroesophageal Reflux Disease

Background In this study two different quality of life items are compared, and correlation of patient satisfaction with preoperative and postoperative symptoms after laparoscopic Nissen fundoplication (LNF) for chronic gastroesophageal reflux disease is evaluated. Materials and Methods Between December 2002 and December 2004, 60 patients with a diagnosis of chronic gastroesophageal reflux disease scheduled for laparoscopic Nissen fundoplication were recruited prospectively and volunteered to participate in this study. Patients underwent endoscopy, and their disease-specific symptoms were scored on a scale. Quality of life was measured preoperatively and in the first and sixth postoperative months with two questionnaires: Short Form-36 (SF 36) (preoperatively) and the Gastroesophageal Reflux Disease—Health-Related Quality of Life (GERD-HRQL) (postoperatively). Results In more than 90% of the patients, typical symptoms (regurgitation and pyrozis) were controlled postoperatively (p < 0.001). In the first postoperative month, however, dysphagia (early dysphagia) was seen in 46 (76%) patients, whereas in the sixth postoperative month (late dysphagia) its incidence decreased to only 2 (3.3%) patients. Similarly, in the first postoperative month 42 (70%) patients had gas bloating, but the incidence of this symptom decreased to 26 (43.3%) patients by the sixth month (p = 0.01). The quality-of-life measurements obtained from both SF 36 and GERD-HRQL showed that quality of life of the patients improved significantly in the related domain of each item after surgery (p < 0.001). Conclusions Laparoscopic Nissen fundoplication is an effective operation that controls the typical symptoms and improves the quality of life of patients, but new-onset symptoms affect postoperative well-being. For closer evaluation of the benefits of the operation, we need new questionnaires that comprehensively evaluate the symptom spectrum of GERD both preoperatively and postoperatively.