BACKGROUND: Gastrointestinal fistulas are a serious complication of gastrointestinal tract surgery: they are often accompanied by high levels of morbidity and mortality. Among other things, some fistula characteristics (anatomical site, type of tract, time elapsed to fistula appearance and volume of output) are being considered as of great importance. New therapeutic approaches such as somatostatin are nowadays being tested in order to clarify the benefits of its use. METHODS: A multi-centre, randomized, controlled and prospective trial was carried out (n = 40, March-December, 1988) to evaluate the effectiveness of total parenteral nutrition (TPN) versus TPN + somatostatin in the conservative management of postoperative gastrointestinal fistulas. Since January 1989, wider inclusion criteria have been followed, and all patients (n = 63) who have fulfilled inclusion criteria have been admitted to TPN plus somatostatin treatment. RESULTS:Closure time of fistulas in patients receiving TPN + somatostatin was significantly shorter (13.86 +/- 1.84 versus 20.4 +/- 2.89 days) than in those receiving TPN alone. In the second phase of the study, more time was needed to obtain complete closure of fistulas (15.8 days). CONCLUSION:Somatostatin is a useful therapeutic complement in the management of postoperative gastrointestinal fistulas, since it accelerates their spontaneous closure.
RCT Entities:
BACKGROUND:Gastrointestinal fistulas are a serious complication of gastrointestinal tract surgery: they are often accompanied by high levels of morbidity and mortality. Among other things, some fistula characteristics (anatomical site, type of tract, time elapsed to fistula appearance and volume of output) are being considered as of great importance. New therapeutic approaches such as somatostatin are nowadays being tested in order to clarify the benefits of its use. METHODS: A multi-centre, randomized, controlled and prospective trial was carried out (n = 40, March-December, 1988) to evaluate the effectiveness of total parenteral nutrition (TPN) versus TPN + somatostatin in the conservative management of postoperative gastrointestinal fistulas. Since January 1989, wider inclusion criteria have been followed, and all patients (n = 63) who have fulfilled inclusion criteria have been admitted to TPN plus somatostatin treatment. RESULTS: Closure time of fistulas in patients receiving TPN + somatostatin was significantly shorter (13.86 +/- 1.84 versus 20.4 +/- 2.89 days) than in those receiving TPN alone. In the second phase of the study, more time was needed to obtain complete closure of fistulas (15.8 days). CONCLUSION: Somatostatin is a useful therapeutic complement in the management of postoperative gastrointestinal fistulas, since it accelerates their spontaneous closure.