Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract
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J. Gastrointest. Surg. · Jul 2002
Randomized Controlled Trial Clinical TrialLong-term efficacy of total (Nissen-Rossetti) and posterior partial (Toupet) fundoplication: results of a randomized clinical trial.
The efficacy of fundoplication operations in the long-term management of gastroesophageal reflux disease (GERD) has been documented. However, only a few prospective controlled series support the long-term (>10 years) efficacy of these procedures, and further data are required to also determine whether the type of fundoplication affects the frequency of postfundoplication complaints. The aim of this study was to conduct a randomized, controlled clinical trial to assess the long-term symptomatic outcome of a partial posterior fundoplication as compared to a total fundic wrap. ⋯ On the other hand, a significant difference was observed in the prevalence of rectal flatus and postprandial fullness, which were recorded significantly more often in those undergoing a total fundoplication (P < 0.001 and P < 0.03, respectively). Posterior partial fundoplication seems to maintain the same high level of reflux control as total fundoplication. Earlier observations demonstrating the advantages of a partial fundoplication, which included fewer complaints associated with gas-bloat, continue to be valid after more than 10 years of follow-up.
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J. Gastrointest. Surg. · May 2001
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialToxicity and effects of adjuvant therapy in colon cancer: results of the German prospective, controlled randomized multicenter trial FOGT-1.
In this adjuvant three-arm multicenter trial, we studied whether modulating the standard 5-fluorouracil (5-FU) treatment with either folinic acid (FA) or interferon-alpha-2a (IFN-alpha) was superior to the recommended standard of adjuvant treatment in R0 resected colon cancer, 5-FU plus levamisole (LEV) for 12 months, in terms of toxicity and outcome. From July 1992 to October 1999, a total of 813 patients with resected colon cancer in stage II (T4N0M0; n = 63) or stage III (TxN1-3M0; n = 750) were randomized into three treatment groups and stratified according to N stage and participating centers (64 hospitals). The patients received a postoperative loading dose of 5-FU (450 mg/m2 on days 1 to 5 [arms A and C]) or 5-FU (450 mg/m2) plus FA (Rescuvolin, Medac, Hamburg, Germany, 200 mg/m2 on days 1 to 5 [arm B]). ⋯ The 4-year survival rate in arm B was significantly higher compared to arm A (P <0.02, log-rank test) with arm A being equal to arm C. Adjuvant therapy with 5-FU plus FA plus LEV for 12 months is superior to the recommended standard (5-FU + LEV for 12 months). IFN-alpha modulation of 5-FU (plus LEV) adds to the toxicity with no therapeutic benefit.