Mid- and long-term quality of life assessments after laparoscopic fundoplication and refundoplication: a single unit review of more than 500 antireflux procedures.

BACKGROUND: For the evaluation of surgical interventions, quality of life data are being increasingly used as an efficacy endpoint. AIMS: To evaluate impact of laparoscopic fundoplication and laparoscopic refundoplication on quality of life as well as on patient satisfaction with the procedure for at least 5 years after surgical intervention. PATIENTS: After more than 500 laparoscopic antireflux procedures, quality of life data have been prospectively reviewed and data compared with healthy individuals, untreated gastro-oesophageal reflux disease patients (n = 150) and successfully treated patients (n = B4) under adequate omeprazole therapy. METHODS: Gastrointestinal Quality of Life Index has been used in all patients and evaluated the day before surgery and 5 times after surgery. Moreover, the SF-36 questionnaire has been used up to 2 years after surgical intervention, but only in patients who underwent laparoscopic redo-surgery (n = 49). RESULTS: In both surgical groups, mean preoperative Gastrointestinal Quality of Life Index showed a significant (p < 0.01) impairment (before laparoscopic antireflux surgery: 90.4 +/- 10.3 points; before redo-surgery: 84.3 +/- 8.1 points) when compared with healthy individuals (mean: 122.6 +/- 8.5 points) and successfully treated patients with acid-suppressive therapy (mean: 121.4 +/- 9.2 points). After surgery, the mean Gastrointestinal Quality of Life Index increased significantly and remained stable for at least 5 years after laparoscopic antireflux surgery (120.8 +/- 8.6 points) or for at least 2 years after redo-proce-dure (120.9 +/- 7.2 points). Before laparoscopic refundoplication, 6 out of 8 SF-36 scores were significantly p < 0.05) decreased. Redo-surgery influenced these 6 scores significantly (p < 0.05-0.01), resulting in values comparable to those of general population. Patients' satisfaction with surgery was excellent or good in 95%. CONCLUSION: Both, laparoscopic fundoplication as well as laparoscopic refundoplication are able to improve patients' quality of life significantly for at least 5 years. Therefore, quality of life data provide useful information to discuss different treatment options with patients.

Austrian experiences of antireflux surgery.

BACKGROUND: Antireflux surgery (ARS) is a well established treatment for GERD (gastroesophageal reflux disease). The present study gives an overview of experience in Austria regarding the frequency of open and laparoscopic ARS and how Austrian departments meet the requirements for surgery. METHODS: A questionnaire was sent to 115 surgical departments in Austria to evaluate in how many institutions antireflux surgery (open and/or laparoscopically) was performed since 1990, and which pre- and postoperative tests were obligatory, optional, or not performed. Units were divided into specialized and nonspecialized. RESULTS: The laparoscopic approach has gained in importance by about 300% in the past 5 years in the few hospitals performing this procedure. Esophageal manometry and 24-h pH monitoring were rarely done in nonspecialized units, despite the fact that GERD is mainly a functional disorder of the esophagus and stomach. In contrast to the nonspecialized units, the specialized unit performed upper endoscopy, esophageal manometry and 24-h esophageal pH monitoring as obligatory tests. CONCLUSIONS: ARS, both open and laparoscopic, is not commonly performed in surgical departments in Austria but the frequency has significantly increased in recent years. Laparoscopic ARS is a safe procedure in hospitals performing this frequently. Laparoscopic ARS should only be performed in specialized units with significant experience in gastroesophageal diseases, where functional testing of the esophagus can be done.

Long-term results of laparoscopic antireflux surgery.

BACKGROUND: It is estimated that laparoscopic antireflux surgery has replaced the open approach in centers worldwide. Findings show it to be an established treatment option for chronic gastroesophageal reflux disease with an excellent clinical outcome and success rates between 85% and 95%. This prospective study aimed to evaluate surgical outcome and analysis of failure after 500 laparoscopic antireflux procedures followed up for as long as 5 years. METHODS: Between September 1993 and May 2000, 500 laparoscopic antireflux procedures were performed in our surgical unit. In 345 patients, a laparoscopic "floppy" Nissen fundoplication was performed, and in 155 patients, a Toupet fundoplication was carried out with standard mobilization of the upper part of the gastric fundus and with division of the short gastric vessels. Preoperative and postoperative data including 24-h pH monitoring, esophageal manometry, and analysis of failure were prospectively reviewed. RESULTS: Conversion to open surgery was necessary in two patients (0.4%). Morbidity was 7%, including 24 patients (4.8%) for whom a laparoscopic redoprocedure was necessary because of failed primary intervention. There was no mortality. During a follow-up period of 3 months to 5 years, 24-h pH monitoring and esophageal manometry showed normal values in 95% of the patients including patients who had undergone redosurgery. CONCLUSION: The results of the current study demonstrate that laparoscopic antireflux surgery is feasible and effective, and that it can be performed safely without mortality and with low morbidity, yielding good to excellent results over a follow-up period up to 5 years.

Dysphagia and quality of life after laparoscopic Nissen fundoplication in patients with and without prosthetic reinforcement of the hiatal crura.

BACKGROUND: Recurrent hiatal hernia with or without intrathoracic wrap migration ("slipping Nissen") is one of the most common complications after laparoscopic Nissen fundoplication (LNF). Therefore, we decided to reinforce the hiatal crura using a prosthetic mesh prosthesis in an attempt to reduce recurrent hiatal hernia. METHODS: The current nonrandomized study compares the surgical outcome, including quality of life data [Gastrointestinal Quality of Life Index (GIQLI)] and subjective degree of dysphagia, in a total of 200 patients with (n = 100) or without (n = 100) mesh prosthesis for a follow-up for at least 1 year. RESULTS: There are no significant differences between groups in postoperative DeMeester score or lower esophageal sphincter pressure. In the group without mesh prosthesis, in 6 cases laparoscopic redo surgery was necessary due to severe and persistent dysphagia (n = 2) or a slipping Nissen (n = 4). Additionally, in 5 patients we found recurrent hiatal hernia, but patients have been without symptoms for at least 1 year. In the group with mesh prosthesis, laparoscopic refund application was performed in only 1 patient due to a slipping Nissen. In this group, recurrent hiatal hernia was not found in endoscopy. After laparoscopic antireflux surgery, GIQLI showed an equal improvement in both groups with an outcome comparable to that for healthy individuals. Postoperative dysphagia was significantly higher in the group with mesh prothesis within the 3 first months after surgery. One year after surgery no differences could be found. CONCLUSIONS: Our findings suggest that LNF with reinforcement of the hiatal crura reduces the risk of recurrent hiatal hernia with or without wrap migration. In addition, LNF with mesh prosthesis improves patient's quality of life significantly to the same level as that in patients without mesh prosthesis. Postoperative dysphagia is higher in the early period after surgery, but this is only temporary. Long-term results of a randomized trial must be obtained before a general standardization can be discussed.

Is laparoscopic refundoplication feasible in patients with failed primary open antireflux surgery?

BACKGROUND: Due to the widespread availability and acceptance of minimal-access surgery, laparoscopic antireflux surgery has become the standard procedure for the treatment of severe gastroesophageal reflux disease (GERD). However, open and laparoscopic antireflux procedures sometimes result in failure, so that redosurgery is required in some cases. The aim of this prospective study was to evaluate the surgical outcome and quality of life of patients who underwent refundoplication after the failure of primary open antireflux surgery. METHODS: Twenty patients with a mean age of 52 years (range, 33-69) underwent laparoscopic refundoplication after primary open antireflux surgery. Four of them had undergone surgery twice previously. Preoperative and postoperative data, including esophageal manometry, 24-h pH monitoring, and assessment of quality of life, were reviewed prospectively. Quality of life was evaluated using the Gastrointestinal Quality of Life Index (GIQLI). RESULTS: In 18 patients (90%), the reoperation was completed successfully laparoscopically. Two others (10%) required conversion to an open procedure. One of them had an injury of the gastric wall; in the other case, severe bleeding of the spleen necessitated the conversion. The average operating time was 245 min. Preoperatively, the main symptoms were recurrent reflux in 14 cases and a combination of re-reflux and dysphagia in six cases. The anatomic findings were telescope phenomenon (n = 6), hiatal disruption (n = 10), and wrap breakdown (n = 4). Postoperatively, two patients suffered from dysphagia and required pneumatic dilatation. The lower esophageal sphincter (LES) pressure increased significantly from a preoperative value of 6.08 mmHg to 12.2 mmHg at 3 months and 11.9 mmHg at 1 year after surgery. The DeMeester score decreased from a preoperative value of 69.8 to 17.1 at 3 months and 14.6 at 1 year postoperatively. The GIQLI score increased from a preoperative value of 84.9 points to 119.6 points at 3 months and 120.1 points at 1 year. CONCLUSION: Laparoscopic refundoplication after the failure of a primary open intervention is an effective procedure that can be performed safely by experienced laparoscopic surgeon. The procedure yields excellent functional results and leads to significant improvement in the patient's quality of life.

Psychological intervention influences the outcome of laparoscopic antireflux surgery in patients with stress-related symptoms of gastroesophageal reflux disease.

BACKGROUND: Psychological aspects such as stress, emotions, illness behaviour or personality are known to affect the severity of symptoms of gastroesophageal reflux disease (GERD) and can influence medical outcome in some patients. The aim of the present study was to evaluate the efficacy of psychological intervention within routine surgical care on the surgical outcome of laparoscopic antireflux surgery (LARS) in patients with stress-related GERD symptoms during a 1-year follow-up. METHODS: Out of a sample of 196 consecutive patients who required LARS (Nissen fundoplication), a group of 89 (45%) believed that stress was a factor in the cause of their symptoms (stress-related versus stress-unrelated GERD patients). Patients with stress-related symptoms were randomly assigned to the psychological intervention (PI group; n = 42) or control group with routine surgical care (RC group; n =42). Five patients were excluded from the study. Assessments of surgical outcome were: objective clinical data such as DeMeester score or lower oesophageal sphincter pressure, Gastrointestinal Quality-of-Life Index (GIQLI), evaluation of potential side effects such as subjective degree of dysphagia, general impairment as a result of LARS, and patient satisfaction with surgery. RESULTS: There were no significant differences in objective clinical data between the different treatment groups before and after surgery. Before surgery, patients with stress-related symptoms had a lower GIQLI and an increased spectrum of gastrointestinal (GI) symptoms compared with patients without stress-related symptoms. A significant impact (P < 0.05-0.01) of psychological intervention on quality-of-life data, especially in GI symptoms, degree of dysphagia and general impairment, could be calculated after surgery. No differences in satisfaction with therapy were detectable. Comparing outcome, no significant differences between patients without stress-related GERD symptoms and the PI group were found. Generally, quality-of-life data in all patients improved significantly and patient satisfaction was excellent or good in 98.9% one year after surgery. In two patients a laparoscopic refundoplication was necessary because of a 'slipping Nissen'. CONCLUSIONS: These findings indicate that there is no impact of psychological intervention on objective clinical data. Patients with stress-related GERD symptoms profit significantly from psychological intervention in patient-related factors of surgical outcome such as quality of life or degree of several aspects such as dysphagia and general impairment. Generally, LARS in patients with stress-related GERD symptoms is an effective and safe procedure which improves quality of life with fewer side effects. Psychological intervention reduces non GERD-related GI symptoms and makes the outcome comparable to the outcome of patients without stress-related symptoms. We therefore suggest that surgical treatment alone in patients with stress-related GERD symptoms is incomplete and that psychological intervention can optimize surgical outcome in these patients.

Quality of life and surgical outcome after laparoscopic antireflux surgery in the elderly gastroesophageal reflux disease patient.

BACKGROUND: Generally, treatment of gastroesophageal reflux disease (GERD) in the elderly follows the same principles as for any adult patient. Currently laparoscopic antireflux surgery (LARS) has not been clearly established in the elderly patient. The aim of this prospective study was to evaluate the surgical outcome including quality of life after LARS in patients older than 65 years. METHODS: Since 1993 more than 500 patients underwent LARS in our institute. A total of 72 patients, older than 65 years, has been treated with laparoscopic 'floppy' Nissen (n = 51) or Toupet (n = 21) fundoplication. The patients included 23 women and 49 men, with a mean age of 71 years (range, 66-79 years). Quality of life was evaluated using the Gastrointestinal Quality of Life Index (GIQLI). The GIQLI was evaluated prior to surgery, and 3 months and 1 year after surgery, with 24-h pH monitoring and esophageal manometry being performed. RESULTS: Intraoperative complications occurred in two patients (both injury of the spleen), successfully managed laparoscopically. Conversion to laparotomy and mortality were 0%. Postoperative complications occurred twice: one patient had a perianal thrombosis; one had an epileptic seizure. Three months and 1 year after surgery 24-h pH monitoring (mean DeMeester score: preoperative, 61.4+/-23.7; 3 months, 8.4+/-6.4; 1 year, 7.8+/-7.2) and esophageal manometry (mean: preoperative, 2.3 = 1.8 mmHg; 3 months, 13.9+/-3.7 mmHg; 1 year, 12.3+/-3.2 mmHg) showed normal values in all patients. GIQLI increased significantly (mean: preoperative, 86+/-9.7 points; 3 months, 120.1+/-8.9 points; 1 year, 119.3+/-10.1 points) after surgery and is comparable to healthy individuals (118.7 points). One patient suffered from severe dysphagia and required dilatation. In two patients laparoscopic refundoplication was necessary 1 year after the initial procedure because of a 'slipping Nissen' and a 'telescope phenomenon'. Three years after LARS (n = 32) data are comparable to I year after surgery. CONCLUSION: As our data show, LARS can be a safe and effective procedure that significantly improves quality of life in the elderly patient suffering from GERD. Age should no longer be a contraindication to LARS.

[Health-related and disease-specific quality of life assessment after laparoscopic repeated fundoplication]. / Gesundsheitsbezogene und krankheitsspezifische Lebensqualität als Beurteilungsmass der laparoskopischen Refundoplicatio.

PURPOSE: In recent years, the efficacy of laparoscopic antireflux surgery has been well-documented with quality-of-life data. The aim of the present study was to describe the efficacy of laparoscopic redo-surgery using health-related and disease-specific quality-of-life data. METHODS: A sample of 30 patients with mean age of 56 years underwent laparoscopic refundoplication. In 18 patients the primary antireflux procedure was performed by the open technique. In 12 cases the primary intervention was performed laparoscopically. To evaluate quality-of-life the German SF-36 Health Survey and the Gastrointestinal Quality of Life Index (GIQLI) were used and given to all patients before and 3 months and 1 year after redo-surgery. RESULTS: Before surgery, in two (physical functioning, role physical) out of 8 dimensions of SF-36 the values have not decreased significantly (P < 0.05) compared to healthy individuals. Three months after laparoscopic redo-surgery all reduced dimensions improved significantly (P < 0.05). One year after surgery all dimensions are stable and comparable to a healthy population. Prior to redo-surgery, the mean GIQLI was 86.7 points and improved significantly (P < 0.05) to 121.6 and 123.8 points (3 months and 1 year after refundoplication) and reached an equivalent level of comparable healthy individuals (122.6 points). There are no significant differences between patients with an open and laparoscopic initial antireflux procedure at all times of measurement. Postoperative data of only 28 patients were included because in two patients conversion was necessary due to operative problems. CONCLUSION: Because of these results laparoscopic refundoplication can be discussed as an effective method of treatment after failed primary antireflux procedure. Laparoscopic redo-surgery normalizes objective outcome criteria and also improves quality of life.

Quality of life and surgical outcome after laparoscopic Nissen and Toupet fundoplication: one-year follow-up.

BACKGROUND AND STUDY AIMS: Quality of life data are becoming widely accepted as a measure of surgical outcome, but the multifaceted symptoms in patients with gastrointestinal disorders are a challenge for this type of evaluation. The aim of the present study was to determine any potential differences in quality of life, specifically in patients undergoing either laparoscopic "floppy" Nissen fundoplication or Toupet fundoplication. PATIENTS AND METHODS: Using the Gastrointestinal Quality of Life Index (GIQLI), the quality of life data for 175 consecutive patients undergoing laparoscopic "floppy" Nissen (n=107) or Toupet (n=68) fundoplication at our department of surgery over a period of 30 months were evaluated prospectively. The patients included 97 men and 78 women, with a mean age of 52 years. The GIQLI creates a general score for quality of life by classifying five different subscales: gastrointestinal symptoms, emotional status, physical and social functions, and stress of medical treatment. This questionnaire was given to the patients preoperatively, and on three occasions after surgery -- at six weeks, three months, and one year. RESULTS: The analysis showed that the patients had a low GIQLI preoperatively in comparison with healthy individuals (mean 90.4 vs. 122.6 points), with all subscales being affected. The general score improved significantly six weeks postoperatively (mean: 118.2 points; P<0.05), showed further improvement at three months (mean: 124.2 points), and remained stable at one year (mean: 123.1 points; P<0.01) postoperatively. There were no differences in the quality of life or side effects between patients with a Nissen or Toupet fundoplication, except regarding the frequency of mild, transient dysphagia. CONCLUSIONS: Patients with gastroesophageal reflux disease suffer from a poor quality of life. After laparoscopic fundoplication, the quality of life improves and becomes comparable to that of healthy individuals. In our view, quality of life data should be evaluated as a major factor in determining the role of surgical interventions. Patients should receive consultation and advice regarding quality of life questions prior to surgery.