Clinical study
Clinical effectiveness of laparoscopic fundoplication in a U.S. community

https://doi.org/10.1016/S0002-9343(02)01390-6Get rights and content

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.

Section snippets

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

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

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

Acknowledgements

We are grateful to Janet Edwards of UnitedHealthcare of Wisconsin Inc. for her assistance with the study.

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