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     

Long-term detrimental effect of bile duct injury on health-related quality of life

HYPOTHESIS: Long-term quality of life (QOL) in patients undergoing laparoscopic cholecystectomy (LC) incurring bile duct injury (BDI) and repair is comparable to that of patients undergoing uncomplicated LC. DESIGN: Case comparison study. SETTING: Secondary and tertiary care centers. PATIENTS: Eighty-six patients incurring BDI during LC between January 1, 1991, and July 31, 2003, were surveyed. Comparison subjects underwent uncomplicated LC during the same period. MAIN OUTCOME MEASURES: Health-related QOL as assessed by the Karnofsky Performance Scale, Medical Outcomes Study 36-Item Short Form Health Survey (SF-36), and Psychosocial Adjustment to Illness Scale. RESULTS: Fifty patients with BDI (39 [78%] female; mean +/- SEM age, 55 +/- 2 years) and 74 patients with uncomplicated LC (51 [69%] female, mean +/- SEM age, 52 +/- 2 years) responded. Of the 50 BDI patients, 48 (96%) had no stricture and normal liver function at QOL assessment. The mean +/- SEM follow-up period to QOL assessment for the BDI and uncomplicated LC groups was 62 +/- 6 and 47 +/- 3 months, respectively. The mean +/- SD Karnofsky Performance Scale scores were 77 +/- 9 vs 93 +/- 8 for the 2 groups, respectively (P <.001). The mean +/- SD SF-36 physical component scale scores after BDI vs uncomplicated LC were 36 +/- 11 vs 47 +/- 12, respectively (P <.001), compared with 50 +/- 10 for the normal population (P <.001). The mean +/- SD SF-36 mental component scale scores were 43 +/- 14 vs 49 +/- 11 for the 2 groups, respectively (P =.02), compared with 50 +/- 10 for the normal population (P =.01). Patients with BDI scored poorer on the Psychosocial Adjustment to Illness Scale health care orientation and domestic environment scales (P=.01). CONCLUSION: After BDI and repair, there are long-term detrimental effects of BDI on health-related QOL.     

Paradigm shift in the management of gastroesophageal reflux disease

OBJECTIVE: To compare the short-term results of the radiofrequency treatment of the gastroesophageal junction known as the Stretta procedure versus laparoscopic fundoplication (LF) in patients with gastroesophageal reflux disease (GERD). SUMMARY BACKGROUND DATA: The Stretta procedure has been shown to be safe, well tolerated, and highly effective in the treatment of GERD. METHODS: All patients presenting to Vanderbilt University Medical Center for surgical evaluation of GERD between August 2000 and March 2002 were prospectively evaluated under an IRB-approved protocol. All patients underwent esophageal motility testing and endoscopy that documented GERD preoperatively, either by a positive 24-hour pH study or biopsy-proven esophagitis. Patients were offered the Stretta procedure if they had documented GERD and did not have a hiatal hernia larger than 2 cm, LES pressure less than 8 mmHg, or Barrett's esophagus. Patients with larger hiatal hernias, LES pressure less than 8 mmHg, or Barrett's were offered LF. All patients were studied pre- and postoperatively with validated GERD-specific quality-of-life questionnaires (QOLRAD) and short-form health surveys (SF-12). Current medication use and satisfaction with the procedure was also obtained. RESULTS: Results are reported as mean +/- SEM. Seventy-five patients (age 49 +/- 14 years, 44% male, 56% female) underwent LF and 65 patients (age 46 +/- 12 years, 42%, 58% female) underwent the Stretta procedure. Preoperative esophageal acid exposure time was higher in the LF group. Preoperative LES pressure was higher in the Stretta group. In the LF group, 41% had large hiatal hernias (>2 cm), 8 patients required Collis gastroplasty, 6 had Barrett's esophagus, and 10 had undergone previous fundoplication. At 6 months, the QOLRAD and SF-12 scores were significantly improved within both groups. There was an equal magnitude of improvement between pre- and postoperative QOLRAD and SF-12 scores between Stretta and LF patients. Fifty-eight percent of Stretta patients were off proton pump inhibitors, and an additional 31% had reduced their dose significantly; 97% of LF patients were off PPIs. Twenty-two Stretta patients returned for 24-hour pH testing at a mean of 7.2 +/- 0.5 months, and there was a significant reduction in esophageal acid exposure time. Both groups were highly satisfied with their procedure. CONCLUSIONS: The addition of a less invasive, endoscopic treatment for GERD to the surgical algorithm has allowed the authors to stratify the management of GERD patients to treatment with either Stretta or LF according to size of hiatal hernia, LES pressure, Barrett's esophagus, and significant pulmonary symptoms. Patients undergoing Stretta are highly satisfied and have improved GERD symptoms and quality of life comparable to LF. The Stretta procedure is an effective alternative to LF in well-selected patients.     

Quality of life and predictors of long-term outcome in patients undergoing open Nissen fundoplication for chronic gastroesophageal reflux

BACKGROUND: Long-term outcome of antireflux operations as well as pre- and postoperative parameters able to predict their clinical results are still controversial. The aim of the present study was to evaluate long-term quality of life of patients undergoing open fundoplication for chronic GERD and to investigate pre- and early postoperative functional parameters possibly related to persistence or recurrence of symptoms. METHODS: A cohort of 25 patients who underwent open Nissen fundoplications was reviewed for an evaluation of long-term residual symptoms and quality of life at an average follow-up of more than 10 years. Clinical evaluation was performed by using a symptom-specific score (DeMeester's score), 3 health-related quality of life scores, a GERD-specific (GERD-HRQL score) score, and 2 generic scores (SF-36) evaluating physical and psychological well-being. Subjective satisfaction grade of the patients was also investigated. In addition, a univariate analysis is provided, according to the long-term presence or absence of residual symptoms (120.6-month follow-up), taking into account pre- and postoperative (6-month follow-up) data of endoscopy, 24-hour pH monitoring, stationary manometry, and gastric-emptying test. RESULTS: Persistence or recurrence of GERD-specific symptoms (heartburn and regurgitation) were reported by 8 patients (32%); 2 patients (8%) were reoperated on for persistent dysphagia, whereas 17 patients (68%) were asymptomatic. GERD-HRQL and SF-36 scores displayed significant postoperative improvement, which continued in long-term follow-up. Twenty patients (80%) had repeat fundoplication. Among tested parameters, only postoperative mean supine esophageal clearance and gastric emptying half-time, although on average improved significantly after the antireflux procedure, differed significantly in long-term asymptomatic and symptomatic subgroups. In long-term asymptomatic patients, postoperative (6 month) mean supine esophageal clearance was 0.8 +/- 0.3 minutes (P = .011) and 2.4 +/- 0.2 minutes in symptomatic patients. Postoperative (6 month) mean gastric emptying half-time of long-term asymptomatic patients was 93.3 +/- 8.9 minutes, whereas in symptomatic patients it was 127.5 +/- 14.3 minutes (P = .047). CONCLUSIONS: Patients undergoing Nissen fundoplication had a satisfactory long-term quality of life. Clinical results did not deteriorate over time and showed to be related to postoperative esophageal clearance and gastric emptying, which could be regarded as early postoperative predictors of long-term clinical outcome.     

Relationship between subjective and objective outcome measures after Heller myotomy and Dor fundoplication for achalasia

BACKGROUND: The purpose of this study is to assess how subjective evaluation (heartburn, dysphagia, quality of life, and satisfaction) correlates with objective data after Heller myotomy and Dor fundoplication for achalasia. METHODS: A total of 53 consecutive patients with achalasia undergoing laparoscopic Heller myotomy and Dor fundoplication were studied prospectively. Subjective evaluation was done preop and postop using the Gastroesophageal Reflux Disease Health-Related Quality of Life instrument (GERD-HRQL; 0 = best, 45 = worse), 4-point dysphagia and heartburn scales (0 = best, 3 = worst), patient satisfaction scale (0 = very satisfied, 5 = incapacitated), and the SF-12 general health-related quality-of-life score. At 3 months postop, patients were asked to undergo objective evaluation with 24-h pH testing, manometry, and endoscopy. Data are expressed as median (interquartile range) and analyzed by Wilcoxon signed rank test or Mann-Whitney U test. RESULTS: Forty-nine patients were more than 3 months postsurgery. Comparing preop to postop, improvements were found in dysphagia [3 (2-3) to 0 (0-1)], heartburn [1 (0-2) to 0 (0-1)], GERD-HRQL [13.5 (6.3-22.5) to 2 (0-5)], satisfaction [3 (3-4) to 1 (0-1)], and SF-12 mental component summary [46 (37-56) to 58 (50-59)] and physical component summary [46 (36-53) to 55 (48-56)] scores (p < 0.0001 for all). Thirty-eight patients (78%) agreed to undergo objective testing, and complete data were available for 32 (65%). Four of 32 patients (12.5%) had evidence of reflux based on 24-h pH testing. Of nine patients with GERD-HRQL >5, only two had positive pH test (22%). Of 23 patients with GERD-HRQL <5, two had positive pH test (7%). Of four tested patients with moderate to severe heartburn, two had an abnormal pH test. There was no significant relationship between GERD-HRQL score and pH test results. Lower esophageal sphincter pressure (LESP) decreased from 24 (16-35) to 13 mmHg (11-17) (p < 0.001). There was no relationship between dysphagia score and postop absolute LESP or a decrease in LESP after operation. CONCLUSIONS: Laparoscopic Heller myotomy and Dor fundoplication is an effective treatment for achalasia. Subjective evaluation can document patient satisfaction and health-related quality of life but does not accurately reflect postop reflux. Twenty-four-hour pH study is required to accurately assess reflux disease.     

The effect of chronic pain syndromes and psychoemotional disorders on symptomatic and quality-of-life outcomes of antireflux surgery

Psychoemotional disorders (PED) and chronic pain syndromes (CPS) are common problems. Many patients with these disorders also suffer from gastroesophageal reflux disease (GERD). It is unclear how PED/CPS affect outcomes of antireflux surgery; therefore, the purpose of this study was to determine if PED/CPS adversely affects the results of surgical therapy for GERD. All patients referred for surgical therapy for GERD completed both the GERD-HRQL symptom severity instrument and the SF-36 generic quality-of-life instrument prior to surgery. To be candidates for surgery, patients must have symptomatic GERD and objective evidence of pathologic reflux by upper endoscopy, esophageal manometry and 24-hour pH monitoring. Patients underwent either laparoscopic or open Nissen or Toupet fundopli-cation. Six to 24 months postoperatively, patients were evaluated for satisfaction and quality-of-life. Ninety-three percent of control patients compared to 25% of PED/CPS patients were satisfied with surgery (P < 0.001). Dissatisfaction in PED/CPS patients was generally due to persistent or new somatic complaints. Median total GERD-HRQL scores improved for both groups, although postoperative scores were worse in the PED/CPS group. PED/CPS patients had significantly worse SF-36 scores both preop-eratively and postoperatively compared to control patients. SF-36 scores improved in four of eight domains in control patients and none in the PED/CPS patients. In conclusion, PED/CPS patients are generally dissatisfied with antireflux surgery. Although some patients do benefit from surgery, careful patient selection is required. Presented at the Forty-Third Annual Meeting of The Society for Surgery of the Alimentary Tract, San Francisco, California, May 19–22, 2002 (poster presentation).     

Laparoscopic Nissen fundoplication improves quality of life in patients with atypical symptoms of gastroesophageal reflux

Laparoscopic Nissen fundoplication has been shown to improve overall quality of life (QOL) in patients with gastroesophageal reflux, but most studies have not addressed patients with atypical symptoms. We investigated the effect of laparoscopic Nissen fundoplication on QOL using the Gastrointestinal Quality of Life Index (GIQLI) survey modified to address both typical (heartburn, regurgitation, dysphagia) and atypical (hoarse voice, chronic cough, adult-onset asthma, vocal cord polyps) symptoms. One-hundred forty-eight patients underwent laparoscopic Nissen fundoplication for gastroesophageal reflux disease (GERD) at UCLA Medical Center from January 1, 1995 to May 1, 2002. Surveys evaluating pre- and postoperative QOL were administered after surgery: 55 per cent of patients responded (82/148). Forty-eight per cent of all patients (72/148) had atypical symptoms. Perioperative morbidity and mortality were 8.8 per cent and 0.7 per cent, respectively. Mean length of postoperative stay was 2.96 +/- 1.5 days. Mean follow-up for the entire cohort was 18.5 months. Postoperative dysphagia not present before surgery occurred in 4.7 per cent of patients. Eighty per cent of patients were medication-free following surgery. QOL scores for all participants increased significantly from 52.5 +/- 15.3 preoperatively to 72.0 +/- 14.9 postoperatively (P < 0.0001). Patients with atypical symptoms or typical symptoms alone showed significant mean QOL score increases from 48.3 +/- 17.6 preoperatively to 71 +/- 15.7 postoperatively (P < 0.0001) and from 55.7 +/- 12.6 to 72.8 +/- 14.4 (P < 0.0001), respectively. Laparoscopic Nissen fundoplication can effectively improve overall QOL for patients with GERD. Patients with atypical GERD symptoms can experience increases in QOL similar to those with only typical gastrointestinal symptoms.     

Laparoscopic fundoplication: 5-year follow-up

There are few published reports on outcomes of 5 or more years following laparoscopic fundoplication. Gastroesophageal reflux disease (GERD) specific quality of life questionnaires (QOLRAD), short form health surveys (SF12), and queries regarding current medication use and long-term satisfaction were mailed to all patients who underwent laparoscopic fundoplication at our institution. Results are reported as mean +/- SEM. Seventy-six patients underwent laparoscopic fundoplication (63 Nissen, 13 Toupet) between November 1992 and December 1997. Fifty-two patients completed questionnaires (68%). Mean follow-up was 5.1 +/- 0.2 years (range, 4-9 years). Mean QOLRAD scores were 5.8 +/- 0.2, (scale 0-7, a higher score reflecting improved QOL), which is comparable to the general population (6.0 mean). SF-12 mental and physical scores were 46.6 +/- 1.7 and 34.2 +/- 1.6, respectively, versus 50.7 and 51.2 for the general population. Forty-seven patients (92%) would have the procedure again. Eleven (21%) remained on antisecretory medications (15% proton pump inhibitor and 6% H2 receptor antagonists). None of the 11 patients underwent 24-hour pH testing to document persistent acid exposure. Furthermore, postoperative symptoms of heartburn, dysphagia, and abdominal bloating were rated as none to mild in the majority of patients. Laparoscopic fundoplication is an effective long-term treatment for GERD, resulting in high patient satisfaction, improved quality of life, and elimination of antisecretory medicines in the majority of patients.     

Switching from cyclosporine to tacrolimus leads to improved disease-specific quality of life in patients after kidney transplantation

BACKGROUND: Advances in transplantation medicine are linked to improved efficacy of immunosuppressive agents. At the same time, these agents endanger medical success by side effects that may impair survival and quality of life (QOL). This study examined whether conversion to tacrolimus-based immunosuppression due to cyclosporine-related side effects improved. QOL in patients after kidney transplantation. METHODS: In total 64 patients (29 men) with an average age of 51 years (SD+/-12) who had received a kidney allograft an average of 5.6 years (SD+/-4) before conversion participated. The reasons for conversion were cardiovascular/metabolic (n=26) or periodontal/dermatological side effects (n=38) of cyclosporine therapy. QOL was assessed before conversion and in average 7 months thereafter by a global (SF-36) and a disease-specific instrument (ESRD-SCL). RESULTS: Disease-specific QOL (ESRD-SCL, global index) improved significantly (P<.001, explanation of variance [EV]=16.6%) after conversion from cyclosporine to tacrolimus. In detail, cardiac and renal dysfunction (P<.01, EV=12.9%) as well as increased growth of gum and hair (P<.0001, EV=53.2%) were significantly reduced at end of the study. However, global QOL (SF-36) remained unchanged. CONCLUSION: Regardless of the indication (cardiovascular or cosmetic), switching to tacrolimus due to cyclosporine-related side effects improved disease-specific QOL within the short term.     

Quality of life after organ transplantation in type 1 diabetics with end-stage renal disease

Quality of life (QOL) should be an important consideration while choosing therapeutic options for patients with type 1 diabetes mellitus (DM) and end-stage renal disease (ESRD) including dialysis, cadaver (CKT) or living kidney transplant (LKT) or simultaneous pancreas-kidney (SPK) transplant. METHODS: QOL was assessed in four groups of patients with history of type 1 DM and ESRD: recipients of SPK (n = 43), CKT (n = 43), LKT (n = 11) and wait listed (WL) patients (n = 23). Diabetes Quality of Life (DQOL), Short Form-36 (SF-36) and Quality of Well-Being (QWB) questionnaires were utilized. A subset of SPK (n = 19) and CKT (n = 12) recipients underwent longitudinal QOL evaluation. RESULTS: On DQOL questionnaire, SPK group had better satisfaction subscore compared with CKT (1.8 +/- 0.5 vs. 2.2 +/- 0.6, p < 0.01) LKT (1.8 +/- 0.5 vs. 2.4 +/- 0.7, p < 0.05) and WL (1.8 +/- 0.5 vs. 2.6 +/- 0.6, p < 0.001) groups and better impact subscore compared with CKT (1.7 +/- 0.6 vs. 2.1 +/- 0.6, p < 0.05) and WL (1.7 +/- 0.6 vs. 2.3 +/- 0.6, p < 0.01) groups. There were no significant differences on physical/mental composite scores of SF-36. QWB score was better in SPK group vs. WL group (0.62 +/- 0.11 vs. 0.55 +/- 0.04, p < 0.05). Longitudinal decline in satisfaction (2.3 +/- 0.5 vs. 2.6 +/- 0.9, p = 0.058) and impact (2.0 +/- 0.5 vs. 2.2 +/- 0.5, p = 0.019) subscores of DQOL were noted in CKT group. There were no significant changes in the composite scores of SF-36 in both groups. QWB scores declined in the CKT group (0.67 +/- 0.10 vs. 0.61 +/- 0.05, p = 0.01). CONCLUSION: QOL was better in type 1 diabetics with ESRD following transplantation when compared with remaining on WL. SPK transplantation had significant positive effect on diabetes-related QOL which was sustained longitudinally but it was difficult to show an overall improvement in general QOL.     

Efficacy of laparoscopic fundoplication in controlling pulmonary symptoms associated with gastroesophageal reflux disease

BACKGROUND: Gastroesophageal reflux disease (GERD)-induced pulmonary symptoms (PS) can be difficult to control. The effectiveness of laparoscopic fundoplication (LF) in controlling PS among patients with medically recalcitrant GERD is poorly documented. We evaluated our results in controlling important PS in patients with GERD undergoing LF. METHODS: Seventy-four patients (28 men, 46 women) were identified with clinically important PS from a prospective cohort of 155 patients undergoing elective LF for recalcitrant GERD. Median age was 52.5 years (range, 29-84 years). Sixty-seven (91%) patients were taking proton pump inhibitors at the time of operation. Quality of life by using the SF36 physical (PCS) and mental (MCS) component summary scores (normal, 50) and heartburn severity by using the health-related quality of life (HRQOL) (best score, 0; worst score, 45) were measured. RESULTS: All 74 patients with PS survived operation, and minor morbidity occurred in 5 (7%) patients. Median hospital stay was 2 days (range, 1-6 days), and return to normal activity was seen at 2.2 weeks (range, 1-8 weeks). Median follow-up was 12 months. PS were improved significantly (P < .01) for hoarseness (62% to 17.6%), bronchospasm (60% to 9.5%), and aspiration (22% to 1.4%). Before LF, 11 (14.9%) patients required bronchodilators or oral steroids. Postoperatively such therapy was required in only 3 (4.2%) patients (P = .019), with no patient requiring oral steroids. Patients with poorer control of their GERD on the basis of high HRQOL scores had significantly more PS after operation. CONCLUSIONS: A significant number of patients with medically recalcitrant GERD (46% from our prospective database) have important PS. LF can improve PS, decrease requirement for pulmonary medications, as well as improve typical reflux symptoms and quality of life.     

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.     

Predictors of early quality-of-life improvement after laparoscopic gastric bypass surgery

BACKGROUND: Quality of life is getting more attention in the medical literature. Treatment outcomes are now gauged by their effect on quality of life (QOL), along with their direct effect on diseases they are targeting. Similarly, in obesity, consensus has been reached on the importance of QOL as an independent outcome measure for obesity surgery along with weight loss and comorbidity. Therefore, the aim of this study was to assess the impact of patient demographics and comorbidities on short-term QOL improvement after laparoscopic gastric bypass (LGB) surgery. METHODS: The change in QOL after LGB was assessed in 171 patients (147 women, 24 men; mean age, 43.1 y) using the Short-Form-36 (SF-36) questionnaire. Multivariate logistic regression analysis was used to identify patients' demographics and comorbidities predictive of major QOL improvement. RESULTS: Body mass index decreased significantly at 3 months (48.5 +/- 5.8 to 38.4 +/- 5.4 kg/m2; P < .001) with excess weight loss of 37.4% +/- 9.2%. The SF-36 follow-up evaluation showed significant improvement (44.2 +/- 15.7 to 78.6 +/- 15.5; P < .001). A significant inverse correlation was found between QOL (before and after bypass) and the number of comorbidities (r = .29, P = .001; R = .22, P = .005; respectively), but the magnitude of QOL change did not correlate with the number of comorbidities (P = .5). When the entire cohort of patients was dichotomized according to their magnitude of change in SF-36 scores, the univariate analysis showed that the group of patients with no improvement or minor improvement in their SF-36 was characterized by a higher percentage of male sex and a lower prevalence of diabetes. These 2 preoperative factors remained statistically significant in the multivariate analysis. Preoperative diagnosis of type 2 diabetes increased the likelihood of major improvement in QOL after LGB by 6.2 times, whereas being a woman increased this likelihood by 16.1 times. CONCLUSIONS: Significant weight loss was achieved as early as 3 months after LGB, causing substantial improvement in QOL in more than 95% of patients. Women with type 2 diabetes have the highest odds to achieve a major QOL improvement after LGB and therefore they should represent the ideal target population for surgical weight loss programs.     

Palatal implants for the treatment of snoring and obstructive sleep apnea/hypopnea syndrome.

OBJECTIVE: Randomized, double-blinded, placebo-controlled, clinical trial to determine the effectiveness of palatal implants for treatment of mild/moderate obstructive sleep apnea/hypopnea syndrome (OSAHS). STUDY DESIGN AND SETTING: Sixty-two non-obese adults with history of snoring, daytime sleepiness, and mild/moderate OSAHS, were randomized to receive palatal implants (n = 31) or placebo procedure (n = 31). Complete follow-up including quality of life (QOL, SF-36), snoring visual analog scale (VAS), and Epworth Sleepiness Scale (ESS) data were obtained in 62 patients. Seven patients refused follow-up polysomnography for a total of 55 patients (29 implant and 26 placebo). RESULTS: The treatment group (change in score of -7.9 +/- 7.7) was significantly improved compared with the placebo group (change in score of 0.9 +/- 4.3) for apnea/hypopnea index (AHI) (P < 0.0001), QOL, SF-36 (P < 0.0001), snoring VAS (P < 0.0001), and ESS (P = 0.0002). CONCLUSIONS: Palatal implants improve AHI, QOL, snoring intensity, and daytime sleepiness for selected patients with mild/moderate OSAHS.     

The efficacy of hypertonic saline nasal irrigation for chronic sinonasal symptoms.

OBJECTIVE: To assess quality of life (QOL) in patients with sinonasal symptoms in response to hypertonic saline nasal irrigation (HSNI), and to assess HSNI use patterns. STUDY DESIGN AND SETTING: The study was an uncontrolled 12-month follow-up to a randomized controlled trial (RCT) and used HSNI in a community setting. We included 54 participants with recurrent or chronic sinonasal symptoms. Forty participants had been in the intervention group of a previous study; 14 had been control participants. Primary outcome measures were the Rhinosinusitis Disability Index (RSDI), a sinus-symptom severity assessment (SIA), and the Sino-Nasal Outcomes Test (SNOT-20). Secondary outcome measures were frequency and pattern of HSNI use, side effects and satisfaction. RESULTS: Among participants using HSNI in the prior RCT, RSDI scores continued to improve, from 73.2 +/- 2.6 points to 80.6 +/- 2.4 points (P < 0.001). SIA and SNOT-20 scores remained stable. Former control participants reported QOL improvement similar to that of HSNI users in the prior RCT. RSDI scores improved from 62.0 +/- 3.9 points to 79.7 +/- 3.7 points (P < 0.05), SNOT-20 scores improved from 43.5 +/- 5.7 points to 28.4 +/- 4.8 points, and SIA scores improved from 4.2 +/- 0.3 points to 2.6 +/- 0.3 points (P < 0.01). Mean HSNI use for all participants was 2.4 irrigations per week; 33% of participants used HSNI regularly, 55% when symptomatic. Side effects were minor; satisfaction was high. CONCLUSIONS: Participants with chronic sinonasal symptoms reported improved QOL and frequent, satisfying use of HSNI. SIGNIFICANCE: HSNI is an effective adjunctive treatment of chronic sinonasal symptoms.     

Heart Rate Variability Predicts Severe Hypotension after Spinal Anesthesia for Elective Cesarean Delivery

Background: Hypotension due to vasodilation during subarachnoid block (SAB) for elective cesarean delivery may be harmful. Heart rate variability (HRV), reflecting autonomic control, may identify patients at risk of hypotension.

Methods: Retrospectively, HRV was analyzed in 41 patients who were classified into one of three groups depending on the decrease in systolic blood pressure (SBP): mild (SBP > 100 mmHg), moderate (100 > SBP > 80 mmHg), or severe (SBP < 80 mmHg). Prospectively, HRV and hemodynamic data of 19 patients were studied. Relative low frequency (LF), relative high frequency (HF), and LF/HF ratio were analyzed.

Results: Retrospective analysis of HRV showed a significantly higher sympathetic and lower parasympathetic drive in the groups with moderate and severe compared with mild hypotension before SAB (median, 25th/75th percentiles): LF/HF: mild: 1.2 (0.9/1.8), moderate: 2.8 (1.8/4.6), P < 0.05 versus mild; severe: 2.7 (2.0/3.5), P < 0.05 versus mild. Results were confirmed by findings of LF and HF. Prospectively, patients were grouped according to LF/HF before SAB: low-LF/HF: 1.5 (1.1/2.0) versus high-LF/HF: 4.0 (2.8/4.7), P < 0.05; low-LF: 58 +/- 9% versus high-LF: 75 +/- 10%, P < 0.05; low-HF: 41 +/- 10% versus high-HF: 25 +/- 10%, P < 0.05. High-risk patients had a significantly lower SBP after SAB (76 +/- 21 vs. 111 +/- 12 mmHg; P < 0.05).     

Three year’s experience with the Stretta procedure: did it really make a difference?

Background Endoscopic treatment is merging as a new option for GERD treatment. Many modalities have been used with modest short-term success, but no long-term follow-ups have been published. We present our 3-yr experience at Vanderbilt University using endoscopic radiofrequency energy (Stretta procedure) for GERD treatment.Methods Patients with follow-up >6 months were prospectively studied under IRB protocol. All were mailed SF-12 health status questionnaire and GERD specific quality-of-life (QOLRAD) questionnaires, queries about satisfaction with Stretta, and medication use. All were invited for 24-hour pH study.Results Eighty-six Stretta procedures were performed between 8/2000 and 7/2003 on 85 patients; all were outpatients, 89% under conscious sedation. Seventy-seven patients qualified for the study; 61 completed the survey, 24 returned for pH study. Follow-up was 26.2 +/- 7.5 months (6-36). All were on daily PPIs, with proven GERD by pH study or endoscopy. Mean preoperative acid exposure time was 7.8+/-2.6%, mean DeMeester score was 40.2+/-17.6. Postoperative mean acid exposure time was 5.1+/-3.3 (p=0.00l), DeMeester score was 29.5+/-20.5 (p=0.041). Normal postoperative acid exposure time (pH<4 in <4.2%) was achieved in 42% of patients tested. Patients were then divided according to medication use at the end of f/u in 2 groups: Responders (off or >50% decrease in PPI dose), and nonresponders (on >50% of original PPI dose, or had fundoplication). Response rate was 60% (39 patients), 8 nonresponders underwent fundoplication (12%). Satisfaction rate was 73%. Statistically significant difference was found between the 2 groups in all measurements; SF-12 physical and mental score for responders were 45.5+/-10.2, and 52.6+/-7.8; and for nonresponders were 37.8+/-11.2 and 40.9+/-11.3 (p=0.012, p=0.000l), respectively. Statistically significant difference was also found between responders and nonresponders in postoperative acid exposure (4.5+/-3.34 vs 7.2+/-2.3, p=0.034), and DeMeester score (26.3+/-20.4 vs 39.7+/-20.2, p=0.05). Paired T test was used to compare pre- and postoperative acid exposure in each group; statistically significant difference was found only among responders: total reflux time was 7.50+/-2.3 preop and 4.5+/-3.34 postop (p=0.000l), whereas for nonresponders it was 8.6+/-3.7 and 7.2+/-2.3 (p=0.8), DeMeester scores pre- and postop among responders were 40.0+/-19.7 and 26.3+/-20.4, respectively (p=0.016), whereas for nonresponders it was 40.5+/-14.3 and 39.7+/-20.2 (p=0.79).Conclusions Stretta is a safe modestly effective, totally endoscopic treatment for GERD. Symptomatic improvement when achieved is often associated with correlating improvement in distal acid exposure. This exposure normalizes in nearly half the treated patients.Presented at the annual meeting of the Society of American Gastrointestinal Endoscopic Surgeons (SAGES), Denver, CO, USA, 31 March-3 April 2004     

Quality of life following primary vs. redo transthoracic paraesophageal hernia repairs

The purpose of this study was to compare the quality of life (QOL) and functional results of 42 patients undergoing primary (60%) and 23 patients undergoing redo (40%) transthoracic paraesophageal hernia repairs. All patients had a floppy Nissen or Belsey anti-reflux repair with or without a Collis gastroplasty. Morbidity occurred in 12% of patients and was similar between groups (P=1.0). Overall QOL scores were not different between groups. Patients undergoing initial repair were found to have significantly higher QOL scores related to their GERD symptoms (P=0.02). Postoperative GERD symptom scores were not significantly different between groups for heartburn, regurgitation, epigastric/chest pain, or cough. Redo patients had more bloating (P=0.02) and dysphagia (P=0.04). Overall, total GERD scores were higher in the redo group compared to the initial group indicating worse GERD-related dysfunction in the redo group (15.8+/-3.8 vs. 6.3+/-1.6, P=0.03). Functional and QOL analysis of transthoracic paraesophageal hernia repairs indicates that redo procedures are associated with a higher incidence of specific gastrointestinal symptoms and worse GERD-related QOL when compared to initial procedures. These differences, while statistically significant, have limited clinical relevance as the overall QOL was not different between groups and low GERD symptom scores were found in both groups.     

Clinical impact of tamsulosin on generic and symptom-specific quality of life for benign prostatic hyperplasia patients: Using international prostate symptom score and Rand Medical Outcomes Study 36-item Health Survey

AIM: To examine the efficiency of alpha1-blocker treatment on disease-specific and generic quality of life (QOL) in men with clinically diagnosed benign prostatic hyperplasia (BPH), the improvement of QOL scores with International prostate symptom score (I-PSS) and Rand Medical Outcomes Study 36-item Health Survey (SF-36) was prospectively analyzed. METHODS: A total of 68 newly diagnosed patients with symptomatic BPH that satisfied all inclusion and none of the exclusion criteria were prospectively recruited. All patients received 0.2 mg/day of tamsulosin for 12 weeks. All patients underwent pretreatment documentation of lower urinary tract symptoms (LUTS) and assessment of symptom-specific QOL. Symptoms and general health-related QOL (HRQOL) were assessed using the I-PSS and SF-36, respectively. Also, other objective variables, such as prostate volume, maximal urinary flow and postvoid residual urine volume, were evaluated. RESULTS: After 12 weeks, decrease in I-PSS was 27% compared with baseline (from 16.4 +/- 7.18 to 11.9 +/- 7.56). All questionnaires in the I-PSS showed improvement after tamsulosin treatment and the I-PSS QOL score was improved from 4.51 +/- 1.14 to 3.17 +/- 1.38 (P < 0.0001) at 12 weeks after tamsulosin administration. In intragroup comparisons of HRQOL scores with age-gender adjusted SF-36 Japanese national norms, three SF-36 subscales (bodily pain, BP; social function, SF; and mental health, MH) were worse in the BPH group aged over 70 years, while younger BPH groups aged <70 had better mean SF-36 physical function (PF) scores compared with age-gender adjusted Japanese national norms. In the BPH group with a prostatic volume > or =20 mL, three mean SF-36 scales (BP, SF and MH) were significantly improved after tamsulosin treatment. It is noteworthy that these SF-36 subscales were identical to those observed to worsen in the older BPH group compared to Japanese national norms. CONCLUSIONS: Treatment with tamsulosin for symptomatic BPH patients is associated with significant improvement in the generic HRQOL, in addition to disease-specific QOL and symptoms, at 3 months after drug administration. In particularly, for generic HRQOL with SF-36, tamsulosin treatment can efficiently improve three mean SF-36 subscales (BP, SF and MH) that are decreased in older BPH patients.     

Surgical outcome in gastro-esophageal reflux disease patients with inadequate response to proton pump inhibitors

Laparoscopic fundoplication (LF) has been shown to be effective in treatment of patients with gastro-esophageal reflux disease (GERD) requiring long-term medical therapy. Its effectiveness in patients with poor response to proton pump inhibitors (PPIs) has been questioned. We prospectively followed 445 patients with proven GERD inadequately controlled on PPI (up to 120 mg/day) and 274 GERD patients with good response to PPIs (20–120 mg/day) after LF. Patients in both groups underwent 24 h pH testing, esophageal manometry, symptom score evaluation, and quality-of-life (QOL) assessment (SF-36) before and at 6 months, 2 years, and 5 years after surgery. LF was associated with a marked improvement in percentage acid reflux, lower esophageal sphincter pressure, and symptom control in both groups of patients; however, the poor responders to PPIs also had a significant improvement in both physical and mental health component of the QOL assessment. Laparoscopic fundoplication provides an excellent symptom control for GERD patients, even those who have responded inadequately to large doses of PPIs. GERD patients who respond poorly to PPI therapy have significantly lowered physical and mental health QOL scores. Laparoscopic fundoplication in this group of patients leads to marked improvement of both components of QOL by 2 years after surgery.