Clinical effectiveness of laparoscopic fundoplication in a U.S. community
Article Outline
Abstract
Background
The aim of our study was to determine the outcome of laparoscopic fundoplication for reflux disease in a cohort of patients who underwent this procedure in routine clinical practice.
Methods
We identified 151 patients who had undergone laparoscopic fundoplication in a managed care organization in Milwaukee. Symptoms were evaluated using a validated questionnaire. Postoperative medication use and endoscopic and surgical procedures were recorded.
Results
Eighty-seven patients agreed to participate, of whom 80 (41 [51%] men) were eligible. Their mean (± SD) age was 45 ± 12 years, and the mean duration after surgery was 20 ± 10 months. Thirty-six patients (45%) underwent the procedure because their physician recommended it, and 22 (27%) because they thought it would cure their disease. Forty-three patients (61%) were satisfied with the outcome of the procedure. Twenty-six patients (32%) were taking medications on a regular basis for treatment of heartburn, 9 (11%) required esophageal dilation for dysphagia, and 6 (7%) had repeat surgical procedures. Of the 54 patients (67%) who reported new symptoms after surgery, 38 reported excessive gas, 22 reported abdominal bloating, and 22 reported dysphagia. Health-related quality of life was significantly lower in patients with these symptoms.
Conclusion
Medical therapy is required for control of heartburn in approximately one third of patients after laparoscopic fundoplication. New symptoms are common after surgery. Patients need to be better informed about the indications and outcomes of surgery.
Laparoscopic fundoplication for reflux disease has gained popularity because it is less invasive than open surgery and has a shorter recovery (1). Case series from referral centers have reported excellent results after this procedure 2, 3. However, a randomized trial that compared laparoscopic fundoplication with open fundoplication was terminated prematurely because of adverse outcomes in the laparoscopic fundoplication group (4).
Little is known about the outcome of this procedure in routine clinical practice, where the criteria by which patients are selected and the surgical expertise of individual surgeons and institutions may vary. The aim of our study was to determine why patients in routine clinical practice undergo laparoscopic fundoplication and the outcome of the procedure with regard to symptoms and medication use.
Methods
Patient selection
We identified patients who underwent laparoscopic fundoplication between 1997 and 1999 in the largest managed care organization in southeastern Wisconsin (United Healthcare of Wisconsin, Inc.), which had an annual membership of 226,000 to 236,000 during the study. Milwaukee County had a population of 940,164 in 2000 (5). Patients were identified from claims data using codes for laparoscopic fundoplication. All patients received a letter from the managed care organization that outlined the study. Patients who were willing to participate returned a signed informed consent document that permitted release of their names and addresses. Patients who did not respond to the first letter were sent a second invitation.
Patients who agreed to participate completed two questionnaires, described below. A subgroup underwent cognitive testing after completion of the questionnaires. Details of procedures were obtained from medical records and direct patient interview. The protocol was approved by the human subjects review committee at Aurora Sinai Medical Center.
Questionnaires
A general questionnaire obtained demographic information and historical data (duration of reflux symptoms, presence of alarm symptoms, and medication use and dose). The second questionnaire was the Digestive Health Survey Instrument, a validated instrument for the assessment of gastrointestinal symptoms, which has five separate scales. The first four are concerned with symptoms: gastroesophageal reflux, dysmotility, and two irritable bowel syndrome scales. The fifth scale assesses the effects of gastrointestinal symptoms on quality of life. The questionnaire has established reliability and validity in community, primary care, and specialty clinic samples 6, 7; values >28 indicate severe impairment of quality of life, whereas scores <11 are consistent with no impairment (8).
Validation
To prevent bias, we did not communicate with the patients about the contents of the survey until both instruments had been completed and returned; the only communication was a telephone reminder asking patients to return the survey. A random sample of 10 patients underwent cognitive interviewing for clarity, content, and understandability of the questionnaire. After completion of these procedures, a study nurse contacted patients who indicated that they had undergone repeat surgery or esophageal dilation to obtain details of surgical complications and repeat procedures (endoscopic or surgical).
Statistical analysis
Proportions were compared using the chi-squared test or Fisher exact test, as appropriate. The Student t test (two-tailed) was used to compare values for health-related quality of life.
Results
One hundred and fifty-one patients were identified and sent invitations to participate in the study. One patient had died from unknown causes, and 2 had moved with no forwarding address. Of the 148 patients who are presumed to have received the invitation, 87 (59%) agreed to participate. Six patients were identified as children (under 7 years of age) who could not fill out the symptom questionnaire and were therefore excluded. One patient indicated that the operation had not been performed and was excluded. Thus, of the 141 eligible adult patients, 80 (57%) participated.
The 41 men and 39 women in the study had a mean (± SD) age of 45 ± 12 years. The mean duration after surgery was 20 ± 10 months; most of the patients (n = 48; 60%) had surgery 12 or more months before entry into the study. All patients reported heartburn before surgery; 54 (67%) reported regurgitation.
The most common reasons for undergoing fundoplication were medication failure and physician recommendation (Table 1). Forty-three patients (61%) were completely satisfied with the outcome of the procedure; 17 (24%) were somewhat satisfied, 6 (9%) were somewhat dissatisfied, and 4 (6%) were very dissatisfied.
Table 1. Principal Reason for Undergoing Laparoscopic Fundoplication and Satisfaction with Outcome
| Reason for the Procedure* | Number (%) of Patients | Number (%) Satisfied with Outcome† |
|---|---|---|
| Medications did not work | 37 (46) | 32 (87) |
| Physician recommended it | 36 (45) | 27 (75) |
| Thought it would cure the disease | 22 (27) | 18 (82) |
| Did not wish to take medications for long term | 12 (15) | 11 (92) |
| High cost of medications | 4 (5) | 2 (50) |
| To prevent cancer | 3 (4) | 1 (33) |
* Some patients reported more than one reason. |
† Percentage refers to those with the specific reason. |
Symptoms and medication use after surgery
Fifty-four patients (67%) reported new symptoms after surgery (Table 2). The most frequent of these was excessive gas, which was reported by 38 patients who had undergone surgery 21 ± 13 months earlier. Twenty-two patients reported abdominal bloating; they had undergone surgery 19 ± 11 months earlier. Twenty-two patients reported difficulty swallowing a mean of 21 ± 13 months after surgery. Those developing these symptoms postoperatively reported significantly poorer health-related quality of life than did those who were free of these symptoms (Figure).
Table 2. New Symptoms after Surgery and the Duration Patients Suffered These Symptoms from the Time of Surgery in 80 Patients Who Underwent Laparoscopic Fundoplication*
| Time Since Surgery | Dysphagia | Bloating | Excessive Gas |
|---|---|---|---|
| Number (%) | |||
| ≤6 months | 6 (7) | 3 (4) | 5 (6) |
| 7 to 12 months | 0 | 3 (4) | 7 (9) |
| >12 months | 16 (20) | 16 (20) | 26 (32) |
| Total | 22 (27) | 22 (26) | 38 (47) |
* Some patients had more than one symptom. |
Figure.
Health-related quality of life (mean ± SD) in patients developing new symptoms after surgery. The quality-of-life scale is disease specific, and general population scores are less than 11; values greater than 28 indicate severe impairment.
Heartburn, regurgitation, abdominal pain, and diarrhea
Twenty-six patients (33%) reported symptoms of heartburn after surgery, including 6 patients who had symptoms daily or several times per week. Overall patient satisfaction with the procedure was significantly greater in patients with resolution of heartburn (45 [94%] of 48) than in those who still had heartburn (18 [69%] of 26; P <0.01); 6 patients did not answer this question. Regurgitation was uncommon after surgery. Two patients reported symptoms of regurgitation daily or several times per week, whereas 13 reported occasional symptoms of regurgitation. Forty patients (50%) reported abdominal pain, including 18 with symptoms occurring at least weekly. Twelve patients reported loose bowel movements at least once per week, and 9 reported an increased frequency of bowel movements at least once per week. Patients with symptoms of heartburn at least once weekly reported a significantly higher pain score (29 ± 23) than did patients without these symptoms (15 ± 17; P = 0.01). Patients with heartburn also had higher scores on the reflux scale (45 ± 15) than did patients without these symptoms (22 ± 14; P <0.0001).
Twenty-six patients (32%) were taking medications on a regular (at least weekly) basis for treatment of heartburn, including 17 who were taking medications daily. Sixteen patients were taking proton pump inhibitors, 5 were taking prescription histamine-2 receptor antagonists, and 3 were taking over-the-counter histamine-2 receptor antagonists. Twenty-four patients were taking antacids regularly.
Surgeons, complications, and repeat operations
Twenty-eight surgeons performed the procedures at 17 hospitals. The managed care organization requires board eligibility, and individual hospital committees determine if a surgeon has privileges to perform laparoscopic fundoplication. One patient developed a splenic tear and underwent splenectomy. Another patient had a gastric perforation that was repaired surgically. One patient developed postoperative pancreatitis. Twenty-three patients (29%) underwent a total of 76 endoscopic procedures in the postoperative period, of whom 2 had undergone multiple dilation procedures for dysphagia. Nine patients (11%) required esophageal dilation for dysphagia. Six patients (7%) underwent repeat surgery for postoperative symptoms, including 4 with postoperative dysphagia, 2 of whom have undergone three operations each and continue to have major symptoms of dysphagia. One patient developed an incisional hernia that was repaired surgically.
Discussion
We found that the effectiveness of laparoscopic fundoplication in routine clinical practice is poorer than has been reported by referral centers. Effectiveness is an important consideration in disease management and patient education programs because some treatments with proven efficacy are less effective in typical clinical practice (9). Our data suggest that patients need more information about the indications, advantages, and disadvantages of surgery. A few patients underwent surgery solely to prevent esophageal cancer, although controlled studies have shown no change in the incidence of cancer when patients treated surgically were compared with patients treated with medical therapy (10). Many patients in our study believed incorrectly that surgery would cure their disease or eliminate the need for medications.
Studies on the outcome of surgery have reported relatively high global satisfaction rates, despite poor outcomes as measured by symptom response and the need for medication use (11). We had similar results. In large measure, this is due to the use of global measures of satisfaction, which may not reflect the aspects of health that are most closely related to the quality of care or outcome (12). Disease-specific measures of quality of life and symptoms provide more specific information about the outcome being studied (13).
Abdominal bloating and the passage of excessive gas are frequent after laparoscopic fundoplication, and many patients are unable to belch after undergoing this procedure (14). In our study, these symptoms often persisted beyond the first year. Dysphagia was also common and often persistent. Several patients underwent multiple dilation procedures, and some had surgical revisions because of intractable dysphagia. Most 15, 16, 17, but not all (18), studies have reported dysphagia in about 30% of patients, with symptoms persisting for a year and requiring dilation in 7% of patients.
About one third of our patients had persistent heartburn requiring medical therapy. A recent study suggested that as many as 60% of patients need medication 10 years after open fundoplication (11). These data suggest that regular use of acid suppressive therapy is required in a substantial number of patients and that the prevalence of heartburn may increase with time.
As with most surgical procedures, results depend to some extent on the skill of the surgeon. Outcomes of fundoplication are better in more experienced hands 19, 20. Laparoscopic fundoplication has been performed in Milwaukee since 1991, and published reports from academic institutions and private groups in Milwaukee have reported high success rates 21, 22. Current surgical guidelines do not specify a specific number of procedures for competence in laparoscopic fundoplication (23). The complication and re-operation rates in our patients are consistent with published data from other groups, including referral centers, suggesting that poor surgical technique cannot account for our results 24, 25, 26.
Our study was designed so that it did not influence the selection of patients for surgery, and it therefore provides a measure of what happens in routine clinical care. We used a validated symptom questionnaire with a disease-specific quality-of-life scale, and we did not contact patients directly until after the study instruments were completed. However, our study also had several limitations. Legal restrictions on managed care organizations do not permit them to release patient names and addresses without their consent. We were therefore unable to include patients who did not respond to mailed requests to participate in the study. If a perfect outcome (no heartburn, no new symptoms, and no need for medications) is assumed for adult patients who had the operation but who did not participate in the study, the cohort size would increase to a total of 141. Under these circumstances, 18% of the cohort would be taking antisecretory medications, 38% would have new symptoms, 28% would have excessive gas, and 16% would have bloating and dysphagia. Our principal conclusions—that a substantial number of patients undergo fundoplication for questionable reasons and that new symptoms that affect quality of life are common after surgery—would remain unchanged.
Acknowledgements
We are grateful to Janet Edwards of UnitedHealthcare of Wisconsin Inc. for her assistance with the study.
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PII: S0002-9343(02)01390-6
doi:10.1016/S0002-9343(02)01390-6
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