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A Prospective, Blinded, Randomized Clinical Trial

Emma J. Patterson, MD; Daniel M. Herron, MD; Paul D. Hansen, MD; Najib Ramzi, MSc; Blayne A. Standage, MD; Lee L. Swanström, MD

Arch Surg. 2000;135:1055-1061.

Hypothesis  Based on retrospective, uncontrolled studies, it has been claimed that Nissen fundoplication should be performed over an esophageal bougie to minimize postoperative dysphagia. We hypothesized that a surgeon experienced in laparoscopic fundoplication will have similar rates of postoperative dysphagia whether or not an esophageal bougie is used.

Design  A patient and observer blinded, randomized, prospective clinical trial to assess the effect of intraoperative bougie use.

Setting  A tertiary care teaching hospital that is a regional referral source for complex laparoscopic foregut surgical procedures.

Patients  Three hundred thirty-six consecutive patients referred for laparoscopic fundoplication between March 1, 1996, and July 31, 1998, were evaluated for eligibility based on inclusion criteria and, if applicable, were offered randomization for fundoplication with or without a 56F bougie. One hundred seventy-one patients were enrolled in this study.

Interventions  All patients underwent laparoscopic Nissen fundoplication, 81 with a bougie (hereafter referred to as the bougie group) and 90 without a bougie (hereafter referred to as the no bougie group).

Main Outcome Measures  Dysphagia severity and frequency were assessed by a blinded observer using a standardized scoring system. Incidence of complications related to the use or absence of a bougie, operative times, and postsurgical recovery was also assessed.

Results  The mean operating time was 148 minutes (range, 65-295 minutes). The overall operative morbidity was 9% (7.4% in the bougie group and 11% in the no bougie group, P= .41). One esophageal injury (1.2%) occurred in the bougie group. The 30-day mortality was 0. Long-term dysphagia assessment was completed in 90% of patients, with a mean follow-up of 11 months. Overall, long-term postoperative dysphagia was present in 13 patients (17%) in the bougie group and 24 patients(31%) in the no bougie group (P= .047). Severe dysphagia occurred in 5% of patients in the bougie group and 14% in the no bougie group.

Conclusion  This study confirms the dogma that use of a large-caliber stent during the creation of a fundoplication decreases the long-term incidence of dysphagia; albeit at the risk of injury from the introduction of a bougie.

From the Minimally Invasive Surgery Department, Legacy Health System, Portland, Ore. The authors have no commercial, proprietary, or financial interests in the products or companies described in this article.

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