Marusch F, Koch A, Schmidt U, Zippel R, Geissler S, Pross M, Roessner A, Köckerling F, Gastinger I, Lippert H
An-Institut für Qualitätssicherung in der operativen Medizin gGmbH, Otto-von-Guericke-Univesität Magdeburg, Leipziger Strasse 44, 39120 Magdeburg.
Chirurg. 2002 Feb;73(2):138-45; discussion 145-6. doi: 10.1007/s00104-001-0367-3.
Currently, only a small percentage of the diagnostic and therapeutic data on colonic carcinomas has been confirmed by data obtained in randomized controlled studies. For this reason, the results of prospective multicentre observational studies are extremely important.
Within a multicentre observational study involving 75 surgical departments carried out between 01.01. and 31.12.1999, 3,756 patients with a colorectal carcinoma (2,293 carcinoma of the colon; 1,463 carcinomas or the rectum) were investigated prospectively using a standardised questionnaire.
The OP rate was 98.4%, the resection rate 92.5% (colon 94.1%, rectum 89.9%). The rate of rectal extirpations was relatively high at 30.3%. General postoperative morbidity was 27.4% (colon 27.0%, rectum 27.9%); the specific postoperative morbidity was 24.6% (colon 21.8%, rectum 29.1%). The anastomotic insufficiency rate was 5.2% (colon 3.7%, rectum 9.5%). The 30-day mortality rate was 4.7%, and the postoperative mortality rate 5.7%.
Surgical quality control in the form of prospective multicentre observational studies make possible the analysis of the therapeutic situation of a surgical disease under quality assurance aspects. At the same time, the comprehensive data material available will serve the specific planning of prospective randomized studies. With the aid of the present study, a basis for a thorough and complete evaluation of colorectal carcinoma has been created.
目前,关于结肠癌的诊断和治疗数据中,只有一小部分已通过随机对照研究获得的数据得到证实。因此,前瞻性多中心观察性研究的结果极为重要。
在一项于1999年1月1日至12月31日期间开展的涉及75个外科科室的多中心观察性研究中,使用标准化问卷对3756例结直肠癌患者(2293例结肠癌;1463例直肠癌)进行了前瞻性调查。
手术率为98.4%,切除率为92.5%(结肠癌94.1%,直肠癌89.9%)。直肠切除术的比例相对较高,为30.3%。术后总体发病率为27.4%(结肠癌27.0%,直肠癌27.9%);术后特定发病率为24.6%(结肠癌21.8%,直肠癌29.1%)。吻合口漏发生率为5.2%(结肠癌3.7%,直肠癌9.5%)。30天死亡率为4.7%,术后死亡率为5.7%。
以前瞻性多中心观察性研究形式进行的手术质量控制,使得在质量保证方面分析外科疾病的治疗情况成为可能。同时,现有的全面数据资料将为前瞻性随机研究的具体规划提供帮助。借助本研究,已为全面彻底评估结直肠癌奠定了基础。