Quality of Life Following Laparoscopic Antireflux Surgery for Primary and Recurrent Gastroesophageal Reflux Disease

VAS (visual analog scale ) of patient satisfaction with symptom control score range from 0 (no relief) to 100 (complete symptom relief), more than 70 equals symptom control

De Mester symptom score to evaluate GERD symptoms (heartburn, regurgitation, and dysphagia) total range from 0 (no GERD symptoms) to 9 (maximum symptoms)

EQ-5D (EuroQol-5-dimension) score of five dimensions (mobility, self-care, pain, usual activities, psychological status), range from 0 (equivalent to being dead) to 1 (best health state imaginable)

GERSS (gastroesophageal reflux symptom score ) product of severity and frequency of five symptoms (heartburn, regurgitation, bloating, dysphagia and epigastric/retrosternal pain) scale range from 0 to 60, less than 18 equals symptom control

GRACI (gastrooesophageal reflux disease activity index ) score of certain GERD symptoms ranging from 74 (no symptoms) to 172 (worst symptoms)

GSRS (gastrointestinal symptom rating scale ) 15 symptoms producing five subscales (reflux, diarrhea, constipation, abdominal pain, indigestion), mean subscale scores range from 1 (no discomfort) to 7 (very severe discomfort)

QOLRAD (quality-of-life in reflux and dyspepsia ) 25 questions comprising five dimensions (emotional stress, sleep disturbance, food and drink, physical and social functionality, vitality) the higher the score, the higher the quality-of-life

REFLUX quality-of-life score assessment of gastrointestinal symptoms, side effects, and complications of both treatments; score range from 0 to 100; the higher the score, the better the patients feel

SF-36 (36-item short form general health and well-being survey) score of eight dimensions (limitations in physical and social activity, physical and emotional role limitations, bodily pain, vitality, general health, general mental health); score range from 0 to 100

PGWBI (psychological general well-being index ) 22 items combining into six dimensions (anxiety, depressed mood, sense of positive well-being, self-control, general health, vitality) the higher the score, the better the well-being

GIQLI (36 items, including 5 subitems: gastrointestinal symptoms, emotional status, physical functions, social functions, and stress by medical treatment); score range from 0 to 144

19.3 The Impact of Gastroesophageal Reflux Disease on Patients Health Related Quality of Life (HRQoL)

A number of studies [2224] have demonstrated that HRQoL in patients presenting with reflux disease is significantly impaired in comparison to the general population, and patients perceive themselves to be as affected by their condition as patients with other serious chronic conditions [24]. Disease severity correlates strongly with HRQoL. Increasing symptom frequency and symptom severity in patients with GERD both lead to lower physical and mental health, and higher levels of work absenteeism. Nocturnal symptoms have an additional negative impact on HRQoL leading to further worsening of physical health [24]. From the patient’s standpoint the QoL will be improved to the extent that reflux symptoms are relieved and surgery-related major side-effects are not acquired.

19.4 The Impact of Laparoscopic Antireflux Surgery on Quality of Life in the Short and Medium Term

In the last two decades laparoscopic antireflux surgery has been shown to improve QoL in patients with GERD. Several randomized trials comparing PPI therapy with laparoscopic antireflux surgery have been conducted, particularly over short-medium terms [618]. Some of these trials [611, 14, 17] showed an advantage for surgical therapy in outcome and cost-effectiveness after a few years, whereas The LOTUS-trial showed an advantage for PPI therapy after 5 years [12, 13, 15, 16].

Mahon et al. [6] randomized 217 patients, 109 to LNF and 108 to PPI therapy. The two groups were well matched for age, sex, weight and severity of reflux. Twenty-four-hour pH monitoring and manometry were performed 3 months after treatment, and quality of life was assessed in both groups using the Psychological General Well-being Index (PGWBI) and the Gastrointestinal Symptom Rating Scale (GSRS) at 3 and 12 months after treatment. The mean gastrointestinal symptom and general well-being scores improved from 31.7 and 95.4 respectively before treatment to 37.0 and 106.2 at 12 months after laparoscopic Nissen fundoplication (LNF) , compared with changes from 34.3 and 98.5 to 35.0 and 100.4 respectively in the PPI group. The differences in both of these scores were significant between the two groups at 12 months (P = 0.003). This study showed that LNF leads to significantly less acid exposure of the lower oesophagus at 3 months and significantly greater improvements in both gastrointestinal and general well-being after 12 months compared with PPI treatment.

In a randomized trial conducted by Anvari et al. [10, 11, 14], the patients randomized to medical therapy received optimized treatment with proton pump inhibitors (PPIs) using a standardized management protocol based on best evidence and published guidelines. The surgical patients underwent LNF. Symptom evaluation was done using the GERD symptom scale (GERSS) and the global visual analog scale (VAS) for overall symptom control. At 3 years, surgery was associated with more heartburn-free days, and a significantly lower VAS score than medical management. Surgical patients also reported improved quality of life on the general health subscore of the Medical Outcomes Survey Short Form 36 (SF-36) at 3 years. The groups did not differ significantly in terms of GERSS or acid exposure on 24-h esophageal pH monitoring at 3 years. The authors concluded that for patients whose GERD symptoms are stable and controlled with PPI, continuing medical therapy and laparoscopic antireflux surgery are equally effective, although surgery may result in better symptom control and quality of life.

The LOTUS trial [12, 13, 15, 16] demonstrated that with modern forms of antireflux therapy, either by PPI-induced acid suppression or after laparoscopic Nissen fundoplication , the estimated remission rates at 5 years were higher in the esomeprazole group (92%) than in the LARS group (85%), log-rank P = 0.048. There was more regurgitation with esomeprazole than with LARS. In contrast, dysphagia, bloating, and flatulence were more common after LARS than with esomeprazole. Both treatments were well tolerated, with no surgery-related mortality. With regard to HRQoL, quality-of-life in reflux and dyspepsia (QOLRAD) scores on the food and drink and vitality dimensions as well as scores on the Gastrointestinal Symptom Rating Scale (GSRS) reflux dimension were the most abnormal at entry and the most sensitive to improve with treatment. The mean scores for all dimensions improved in both groups and remained close to values observed in a healthy population.

In the REFLUX trial [8, 9, 17, 18], a high proportion of patients (53%) had a partial fundoplication in contrast to a standardised, protocol specified total Nissen fundoplication in the LOTUS trial. The main outcome in the REFLUX trial was the score from the REFLUX questionnaire, a validated measure of HRQoL incorporating assessment of reflux related and other gastrointestinal symptoms and side effects and complications of both treatment modalities. Other measures were the overall health status (SF-36 and EuroQoL EQ-5D). Among responders differences in reflux scores at 5 years significantly favored the surgery group. SF-36 scores favored the surgical group in all domains at all time points. However, differences decreased over time, and at 5 years only the norm-based general health and role emotional domains were significantly better in the surgical arm. Mean EQ-5D scores showed a similar pattern—differences all favoring the surgical group within 2–3 years after surgery but at later time points scores were not significantly different. Long term rates of dysphagia, flatulence, and inability to vomit were similar in the medical and surgical groups.

All these trials are consistent in showing small numbers of operations needing to be converted to an open procedure, visceral injuries associated with the procedure, postoperative problems, and a small number of patients requiring dilatation of the wrap. However, quality has varied across these studies, with all trials having limitations in terms of design, duration of follow-up and reporting [25]. Due to these limitations the most recent Cochrane review [25] including four controlled trials concluded that the difference between laparoscopic fundoplication and medical treatment was imprecise for overall short- and medium-term HRQOL, medium-term GERD-specific QoL, percentage of people with adverse events, long-term dysphagia (difficulty in swallowing), and long-term acid regurgitation. The short-term GERD-specific quality of life, however, was better in the laparoscopic fundoplication group than in the medical treatment group.

19.5 The Impact of Laparoscopic Fundoplication on Quality of Life in Partial Responders to PPI-Therapy

Most studies in the surgical literature have included only patients who respond adequately to PPIs . Patients who do not respond adequately to PPI treatment, however, are often referred to surgery. The available evidence for efficacy of laparoscopic fundoplication in patients who do not respond adequately to PPI treatment was reviewed by Lundell et al. [26]. Across the included studies, LF offered a substantial and clinically relevant improvement in GERD symptoms, physiological measures of GERD and QoL parameters in partial responders beyond that provided by PPI treatment alone [26]. Particularly, four trials compared QoL before LF while patients were taking a PPI with that after LF. Of these, three found that GERD-HRQL scores improved 1 year after LF, two reported improvements in VAS scores, including a substantial increase at 1 year and at 10 years after LF. Only one study used the GIQLI scores and reported improved values at 1 year after LF. Symptoms recurred, however, in around 30–35% of patients a decade after LF in those studies reporting long-term follow-up data.

19.6 Impact of Antireflux Surgery on QoL in Patients with Non-erosive Reflux Disease (NERD)

GERD can be subdivided into erosive (ERD) and non-erosive reflux disease (NERD) depending upon endoscopy findings. Decreased QoL and symptom severity are similar in both ERD and NERD. Less is known about the long-term surgical outcome in NERD patients.

The study by Kamolz et al. [27] evaluated the surgical outcome in a well-selected group of EGD-negative patients compared to that of EGD-positive patients. Of more than 500 patients who underwent LARS, 89 EGD-negative patients were treated surgically because of persistent reflux-related symptoms despite medical therapy. In all cases, preoperative 24-h pH monitoring showed pathological values. To perform a comparative analysis, a matched sample of EGD-positive patients was selected from the database. Surgical outcome included objective data (e.g., manometry and pH data and endoscopy), quality of life evaluation with GIQLI), as well as patients’ satisfaction with surgery.

Based on the data of a complete 5-year follow-up there were no significant differences in symptomatic improvement, percentage of persistent surgical side-effects, or objective parameters. In general, patients’ satisfaction with surgery was comparable in both groups: 95% rated long-term outcome as excellent or good and would undergo surgical treatment again if necessary. Quality of life improvement was significantly better (p < 0.05) in the EGD-negative group because of the fact that GIQLI was more impaired before surgery. Five years after surgery, GIQLI in both groups showed comparable values to healthy controls. The authors concluded that LARS is an excellent treatment option for well-selected patients with persistent GERD-related symptoms who have no endoscopic evidence of esophagitis.

In a similar study by Broeders et al. [28] the relief of reflux symptoms at 5 years was similar (EGD negative 89% versus EGD positive 96%). PPI uses showed a similar reduction (82% to 21% versus 81% to 15% respectively; both P < 0.001). QoL score measured by Visual analogue scale (VAS) improved equally 50.3 to 65.2 (P < 0.001) versus 52.0 to 60.7 (P = 0.016). Five patients with NERD developed erosions after surgery; oesophagitis healed in 87% of patients with ERD. Reduction in total acid exposure time and increase in LOS pressure were similar. The reintervention rate was comparable (EGD negative15% versus EGD positive 12.8%).

19.7 The Impact of Laparoscopic Antireflux Surgery on Quality of Life in the Long Term (10 Years)

Up until now, there have only been a few studies comparing postoperative early and late (10 years) results after antireflux surgery, and reporting long-term control of reflux in some 74–90% of patients [2936]. None of the randomized trials comparing laparoscopic fundoplication with PPI therapy has reported long-term (more than 5 years) health-related quality of life (HRQoL) or GERD-specific quality of life QoL.

In a randomized trial by Mardani et al. [29] 99 patients with chronic gastro-oesophageal reflux disease were referred for antireflux surgery and enrolled in the trial. Short gastric vessels were divided completely in 52 patients (group 1) and left intact in 47 (group 2). Quality of life was assessed before surgery and at 1 and 6 months, and 1 and 10 years after operation, using the Psychological General Well-Being (PGWB) index and the Gastrointestinal Symptom Rating Scale (GSRS) .

No statistically significant differences were found between the two study groups for symptoms of heartburn, acid regurgitation, postfundoplication complaints such as gas bloat, and ability to belch or vomit. Scores for dysphagia were identical in the two groups. Health-related quality of life, as assessed by the generic PGWB index, was normal and similar in the two groups, with a mean (s.e.m.) total score of 100.0(17.2) in group 1 and 92.7(21.4) in group 2. The disease-specific GSRS scores also showed the same normal profile in the two study groups. The authors conclusion was that with total fundoplication it makes no difference whether the fundus is mobilized or not. Both types of repair provide lasting control of reflux.

Broeders et al. [30] reported 10 years outcome of a multicenter randomized controlled trial on laparoscopic (LNF) and conventional Nissen fundoplication (CNF) , with focus on effectiveness and reoperation rate. A total of 148 patients (79 LNF, 69 CNF) participated in this 10-year follow-up study. GERD symptoms were relieved in 92.4% and 90.7% (NS) after LNF and CNF, respectively. The effect of surgery on self-rated change in general health was measured on a 3-point scale that ranges from “improved,” to “unchanged,” to “worsened.” A visual analogue scale (VAS), validated for QoL assessment after esophageal surgery, was used to measure the impact on quality of life. The scale ranged from 0 to 100, where zero represented worst possible health and 100 represented perfect health. General health (74.7% vs. 72.7%; NS) and quality of life (visual analogue scale score: 65.3 vs. 61.4; NS) improved similarly in both groups. The percentage of patients who would have opted for surgery again was similar as well (78.5% vs. 72.7%; NS). The authors concluded that the 10-year effectiveness of LNF and CNF is comparable in terms of improvement of GERD symptoms, PPI use, quality of life, and objective reflux control.

Long-term HRQoL and GERD-specific quality of life QoL have been reported also in some observational studies. Dallemagne et al. [31] performed a laparoscopic Nissen fundoplication for 68 patients by tailoring a floppy 360° wrap with routine division of the short gastric vessels and crural repair. A laparoscopic partial posterior fundoplication (Toupet fundoplication) was performed for other 32 patients by tailoring a posterior wrap with routine division of the short gastric vessels and crural repair. At 10 years after antireflux surgery, 89.5% of the patients still were free of significant reflux (93.3% after Nissen, 81.8% after Toupet). Using the Gastrointestinal quality of life index (GIQLI) the authors demonstrated that GIQLI scores at 10 years were significantly better than the preoperative scores of the patients under PPI therapy. The global score, however, remained inferior to the score for a control group of healthy patients. The major difference was found in the “gastrointestinal symptoms” subdivision of the index.

Another observational study by Fein et al. [32] reported 120 patients who had primary laparoscopic fundoplication with a “tailored approach” (type of wrap chosen according to esophageal peristalsis): 88 received a Nissen, 22 an anterior, and 10 a Toupet fundoplication. Follow-up examinations were completed by 99 of 114 patients (87%) at 10 years after surgery, and included disease-related questions and the gastrointestinal quality-of-life index (GIQLI) . Of these, 89% would select surgery again. Heartburn was reported by 30% of the patients. Regurgitations were noted from 15% of patients after a Nissen, 44% after anterior fundoplication, and 10% after a Toupet (P = 0.04). Twenty-eight percent of patients were on acid-suppressive drugs again. Following Nissen fundoplication, proton pump inhibitors were less frequently used (P = 0.01) and pH-metry was less likely to be abnormal. The GIQLI was 110 ± 24 without significant differences between the type of fundoplication. Ten years after laparoscopic fundoplication, overall outcome was good. A quarter of the patients were on acid suppressive drugs. Nissen fundoplication appeared to control reflux better than a partial fundoplication.

In the study by Gee et al. [33], a validated survey instrument, the Gastroesophageal Reflux Disease–Health-Related Quality-of- Life Scale (GERD-HRQL) was mailed to all patients who underwent laparoscopic fundoplications from 1997 to 2006. Additional information was obtained regarding reintervention, satisfaction, and medication use. Median follow-up was 60 months (range, 4–75 months). In patients who underwent primary LF, the mean (SD) GERD-HRQL score was 5.71 (7.99) (range, 0–45, with 0 representing no symptoms). Seventy-one percent of patients were satisfied with long-term results. Forty-three percent of patients took antireflux medications at some point following surgery; half of these patients had no diagnostic testing to document GERD recurrence. Only three patients (1.2%) required reoperation. These results demonstrate that patients undergoing primary LF by an experienced surgical team have near-normal GERD-HRQL scores at long-term follow-up.

In the study by Sgromo et al. [34] the long-term outcome of total (Nissen) and partial (Toupet) fundoplication, performed in a single institution was examined. The QOLRAD questionnaire was used as the quality-of-life measurement. Completed questionnaires were received from 161 patients (61%) of whom 99 had a laparoscopic Nissen fundoplication and 62 laparoscopic Toupet fundoplication. Both procedures were equivalent in improving reflux symptom scores in the long term, 79 of 99 (80%) and 56 of 62 (90%) patients were either symptom free or had obtained significant symptomatic relief. Both groups had equivalent QoL scores on the QOLRAD questionnaire. An equivalent number of patients (86% and 83.9% after Nissen and Toupet, respectively, were sufficiently satisfied to recommend antireflux surgery to a friend or relative complaining of reflux symptoms. The authors conclusion was that long-term satisfaction, general symptom scores, and quality of life are equivalent after laparoscopic Nissen (complete) or Toupet (partial) fundoplication. There is, however, an increased prevalence of persistent heartburn after laparoscopic Toupet fundoplication.

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Jan 7, 2018 | Posted by in GASTROENTEROLOGY | Comments Off on Quality of Life Following Laparoscopic Antireflux Surgery for Primary and Recurrent Gastroesophageal Reflux Disease
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