MEGA

People diagnosed with gastric tumor require surgery to remove the stomach. The previous standard is open gastrectomy. In recent years, minimally invasive surgery ("small incision surgery" or "keyhole surgery") has developed rapidly and is already replacing open surgery as the standard therapy for many general surgical operations. In gastric cancer, too, some studies show that the minimally invasive approach potentially reduces complication rates with equivalent chances of cure. The goal of this study is to show a reduction in severe complications and postoperative pain, better mobilization, faster rehabilitation, and shorter hospital stay after minimally invasive gastrectomy compared with open gastrectomy. For this reason, the Comprehensive Complication Index (CCI), based on the Clavien-Dindo classification, was chosen as the primary endpoint because this well-established index encompasses all possible complications and thus also reflects the patient's assessment better than other indices. Through this study, surgeons will be better able to educate patients about the benefits and risks of surgery using high-quality data, as well as improve the surgical management of gastric cancer through low complication and faster rehabilitation of patients. This would be associated with a shorter hospital stay, which in turn would reduce the burden on the healthcare system.

{ "short_title": "MEGA", "data_mode": "900", "data_mode_number": "000002401", "official_title": "Minimal invasive versus offene Gastrektomie. Eine multizentrische randomisierte kontrollierte Studie.", "accrual_state": "running", "therapeutic_value": "therapeutic", "therapieansatz_value": "not_applicable", "therapieintervention_value": "not_applicable", "therapielinie_value": "not_applicable", "ctgov_number": null, "eudract_number": null, "general_contact_email": "studienzentrum-vtg@ukdd.de", "general_contact_phone": null, "hauptpruefer_dd_name": "Prof. Dr. med. Daniel Stange", "description_laie_de": "Bei Patienten mit einem diagnostizierten Magentumor ist die Entfernung des Magens durch eine Operation notwendig. Der bisherige Standard ist die offene Durchf\u00fchrung dieser Operation \u00fcber die Bauchh\u00f6hle. Diese Behandlung f\u00fchrt zu potenziell h\u00f6heren Komplikationsraten, insbesondere bei \u00e4lteren und \u00fcbergewichtigen Patienten. Diese Komplikationen f\u00fchren wiederum zu einer h\u00f6heren Sterblichkeit, einer geringeren Lebensqualit\u00e4t, einem l\u00e4ngeren Krankenhausaufenthalt und damit zu einer h\u00f6heren Belastung des Gesundheitssystems. \r\nIn den letzten Jahren hat sich die minimal-invasive Chirurgie (\u201eChirurgie der kleinen Schnitte\u201c oder \u201eSchl\u00fcssellochchirurgie\u201c) rasant weiterentwickelt und ist in einigen Bereichen bereits der Standard, um Tumore des Magens zu entfernen. \r\nMehrere Studien haben gezeigt, dass im Vergleich zum offenen Zugang weniger Komplikationen nach einem minimal-invasiven Eingriff auftreten, was auf kleinere Wunden, ein geringeres Operationstrauma, weniger Blutverlust, einen k\u00fcrzeren Krankenhausaufenthalt und eine schnellere Wiederherstellung der Gesundheit zur\u00fcckzuf\u00fchren ist. \r\nZiel dieser Studie ist es nachzuweisen, dass ein minimal-invasiver Eingriff schwere Komplikationen und Schmerzen verringert, eine bessere Bewegungsf\u00e4higkeit erm\u00f6glicht, die physischen und psychischen F\u00e4higkeiten schneller wiederherstellt und einen k\u00fcrzeren Krankenhausaufenthalt erm\u00f6glicht im Vergleich zur offenen Operation. \r\nDurch diese Studie werden Chirurgen besser in der Lage sein, Patienten \u00fcber die Vorteile und Risiken beider Operationen anhand qualitativ hochwertiger Daten aufzukl\u00e4ren. Potenziell geringere Komplikationen werden mit einem k\u00fcrzeren Krankenhausaufenthalt einhergehen, was wiederum die Belastung des Gesundheitssystems verringern w\u00fcrde.", "description_laie_en": null, "description_expert_de": null, "description_expert_en": "People diagnosed with gastric tumor require surgery to remove the stomach. The previous standard is open gastrectomy. In recent years, minimally invasive surgery (\"small incision surgery\" or \"keyhole surgery\") has developed rapidly and is already replacing open surgery as the standard therapy for many general surgical operations. \r\nIn gastric cancer, too, some studies show that the minimally invasive approach potentially reduces complication rates with equivalent chances of cure. The goal of this study is to show a reduction in severe complications and postoperative pain, better mobilization, faster rehabilitation, and shorter hospital stay after minimally invasive gastrectomy compared with open gastrectomy. For this reason, the Comprehensive Complication Index (CCI), based on the Clavien-Dindo classification, was chosen as the primary endpoint because this well-established index encompasses all possible complications and thus also reflects the patient's assessment better than other indices. \r\nThrough this study, surgeons will be better able to educate patients about the benefits and risks of surgery using high-quality data, as well as improve the surgical management of gastric cancer through low complication and faster rehabilitation of patients. This would be associated with a shorter hospital stay, which in turn would reduce the burden on the healthcare system.", "rechtsgrundlage_value": "BO", "phase_amg_value": null, "main_cat_id": 2, "sub_cat_id": 5 }

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