评估厄他培南治疗乙状结肠憩室炎急性发作持续时间的研究
2006年2月12日 更新者：Klinikum Hanover-Siloah Hospital
一项前瞻性、多中心、开放标签、随机临床研究，以评估厄他培南治疗乙状结肠憩室炎急性发作的持续时间
本研究的目的是比较乙状结肠憩室炎急性发作患者静脉注射厄他培南抗生素治疗 4 天与 7 天的疗效（通过评估治疗的临床成功率）。
研究概览
研究类型
介入性
注册
540
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Ferdinand Koeckerling, Prof. Dr.
- 电话号码：0049-511-927-2331
- 邮箱：ferdinand.koeckerling.siloah@klinikum-hannover.de
研究联系人备份
- 姓名：Omar Huegel, Dr.
- 电话号码：0049-511-927-2331
- 邮箱：Dr.O.Huegel@arcor.de
学习地点
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Hannover、德国、30449
- 招聘中
- Klinikum Hannover- Krankenhaus Siloah
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接触：
- Omar Huegel, Dr.
- 电话号码：0049-511-927-2331
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首席研究员：
- Ferdinand Koeckerling, Prof. Dr.
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副研究员：
- Omar Huegel, Dr.
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副研究员：
- Pascal Geers, Dr.
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
16年 至 73年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
纳入标准：
- 必须出现乙状结肠憩室炎急性发作的以下至少三种体征或症状：*发烧（体温> 38°C，舌下），*腹部压痛，*白细胞增多（白细胞> 10,000 /μl）和左移血细胞计数差异（>1% 条带形式），*CRP 升高（> 20 mg/l）
- 乙状结肠憩室炎的对比灌肠证据
- 乙状肠管壁增厚的CT证据
- 根据病史和诊断决定支持保守治疗
排除标准：
- 使用研究药物或其他 β-内酰胺类抗生素的禁忌症，例如 晚期肾功能不全患者或需要血液透析的患者
- 研究开始前两周的抗生素治疗
- 晚期不治之症患者
- 患有血液/肿瘤疾病（白血病、淋巴瘤）的患者
- 服用免疫抑制剂的患者
- 导致立即手术指征的乙状结肠憩室炎并发症
- 对β-内酰胺类抗生素过敏的患者
- 怀孕或哺乳或可能在研究期间怀孕的女性患者
- 在参加研究之前的四个星期内参加另一项临床研究或使用另一种研究药物或在研究期间使用另一种药物
- 每个患者只能参加一次研究
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：教育/咨询/培训
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
研究衡量的是什么？
主要结果指标
结果测量 |
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复发率
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临床治疗成功（完全回归）
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开工率
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次要结果测量
结果测量 |
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实验室参数的开发
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住院时间
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肠外喂养的持续时间
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手术干预和重复手术的发生率
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重症监护的发生率和持续时间
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Ferdinand Koeckerling, Prof. Dr.、Klinikum Hanover-Siloah hospital and Nordstadt hospital- Surgical Department
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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- Ambrosetti P, Robert J, Witzig JA, Mirescu D, de Gautard R, Borst F, Meyer P, Rohner A. Prognostic factors from computed tomography in acute left colonic diverticulitis. Br J Surg. 1992 Feb;79(2):117-9. doi: 10.1002/bjs.1800790208.
- Auguste L, Borrero E, Wise L. Surgical management of perforated colonic diverticulitis. Arch Surg. 1985 Apr;120(4):450-2. doi: 10.1001/archsurg.1985.01390280044010.
- Bakker FC, Hoitsma HF, Den Otter G. The Hartmann procedure. Br J Surg. 1982 Oct;69(10):580-2. doi: 10.1002/bjs.1800691007.
- Balthazar EJ, Robinson DL, Megibow AJ, Ranson JH. Acute pancreatitis: value of CT in establishing prognosis. Radiology. 1990 Feb;174(2):331-6. doi: 10.1148/radiology.174.2.2296641.
- Bell GA, Panton ON. Hartmann resection for perforated sigmoid diverticulitis. A retrospective study of the Vancouver General Hospital experience. Dis Colon Rectum. 1984 Apr;27(4):253-6.
- Berry AR, Turner WH, Mortensen NJ, Kettlewell MG. Emergency surgery for complicated diverticular disease. A five-year experience. Dis Colon Rectum. 1989 Oct;32(10):849-54. doi: 10.1007/BF02554554.
- BOLES RS Jr, JORDAN SM. The clinical significance of diverticulosis. Gastroenterology. 1958 Dec;35(6):579-82. No abstract available.
- Chappuis CW, Cohn I Jr. Acute colonic diverticulitis. Surg Clin North Am. 1988 Apr;68(2):301-13. doi: 10.1016/s0039-6109(16)44479-8.
- Cheskin LJ, Bohlman M, Schuster MM. Diverticular disease in the elderly. Gastroenterol Clin North Am. 1990 Jun;19(2):391-403.
- Cheskin LJ, Lamport RD. Diverticular disease. Epidemiology and pharmacological treatment. Drugs Aging. 1995 Jan;6(1):55-63. doi: 10.2165/00002512-199506010-00005.
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- Doringer E. Computerized tomography of colonic diverticulitis. Crit Rev Diagn Imaging. 1992;33(5):421-35.
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- Duma RJ, Kellum JM. Colonic diverticulitis: microbiologic, diagnostic, and therapeutic considerations. Curr Clin Top Infect Dis. 1991;11:218-47. No abstract available.
- Eisenstat TE, Rubin RJ, Salvati EP. Surgical management of diverticulitis. The role of the Hartmann procedure. Dis Colon Rectum. 1983 Jul;26(7):429-32. doi: 10.1007/BF02556519.
- Elsakr R, Johnson DA, Younes Z, Oldfield EC 3rd. Antimicrobial treatment of intra-abdominal infections. Dig Dis. 1998 Jan-Feb;16(1):47-60. doi: 10.1159/000016848.
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- Eusebio EB, Eisenberg MM. Natural history of diverticular disease of the colon in young patients. Am J Surg. 1973 Mar;125(3):308-11. doi: 10.1016/0002-9610(73)90047-0. No abstract available.
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- Barry AL, Fuchs PC, Brown SD. In vitro activity of the ketolide ABT-773. Antimicrob Agents Chemother. 2001 Oct;45(10):2922-4. doi: 10.1128/AAC.45.10.2922-2924.2001.
- Goldstein EJ, Citron DM, Merriam CV, Warren Y, Tyrrell K. Comparative in vitro activities of GAR-936 against aerobic and anaerobic animal and human bite wound pathogens. Antimicrob Agents Chemother. 2000 Oct;44(10):2747-51. doi: 10.1128/AAC.44.10.2747-2751.2000.
- Gottesman L, Zevon SJ, Brabbee GW, Dailey T, Wichern WA Jr. The use of water-soluble contrast enemas in the diagnosis of acute lower left quadrant peritonitis. Dis Colon Rectum. 1984 Feb;27(2):84-8. doi: 10.1007/BF02553980.
- Hachigian MP, Honickman S, Eisenstat TE, Rubin RJ, Salvati EP. Computed tomography in the initial management of acute left-sided diverticulitis. Dis Colon Rectum. 1992 Dec;35(12):1123-9. doi: 10.1007/BF02251962. Erratum In: Dis Colon Rectum 1993 Feb;36(2):193.
- Hackford AW, Schoetz DJ Jr, Coller JA, Veidenheimer MC. Surgical management of complicated diverticulitis. The Lahey Clinic experience, 1967 to 1982. Dis Colon Rectum. 1985 May;28(5):317-21. doi: 10.1007/BF02560431.
- Haglund U, Hellberg R, Johnsen C, Hulten L. Complicated diverticular disease of the sigmoid colon. An analysis of short and long term outcome in 392 patients. Ann Chir Gynaecol. 1979;68(2):41-6. No abstract available.
- Hiltunen KM, Kolehmainen H, Vuorinen T, Matikainen M. Early water-soluble contrast enema in the diagnosis of acute colonic diverticulitis. Int J Colorectal Dis. 1991 Nov;6(4):190-2. doi: 10.1007/BF00341388.
- HORNER JL. A study of diverticulitis of the colon in office practice. Gastroenterology. 1952 Jun;21(2):223-9. No abstract available.
- Hulkko OA, Laitinen ST, Haukipuro KA, Stahlberg MJ, Juvonen TS, Kairaluoma MI. The Hartmann procedure for the treatment of colorectal emergencies. Acta Chir Scand. 1986 Aug-Sep;152:531-5.
- Johnson CD, Baker ME, Rice RP, Silverman P, Thompson WM. Diagnosis of acute colonic diverticulitis: comparison of barium enema and CT. AJR Am J Roentgenol. 1987 Mar;148(3):541-6. doi: 10.2214/ajr.148.3.541.
- Kellum JM, Sugerman HJ, Coppa GF, Way LR, Fine R, Herz B, Speck EL, Jackson D, Duma RJ. Randomized, prospective comparison of cefoxitin and gentamicin-clindamycin in the treatment of acute colonic diverticulitis. Clin Ther. 1992 May-Jun;14(3):376-84.
- Kourtesis GJ, Williams RA, Wilson SE. Acute diverticulitis: safety and value of contrast studies in predicting need for operation. Aust N Z J Surg. 1988 Oct;58(10):801-4. doi: 10.1111/j.1445-2197.1988.tb00983.x.
- Krukowski ZH, Matheson NA. Emergency surgery for diverticular disease complicated by generalized and faecal peritonitis: a review. Br J Surg. 1984 Dec;71(12):921-7. doi: 10.1002/bjs.1800711202.
- Laitinen R, Tahtinen J, Lantto T, Vorne M. Tc-99m labeled leukocytes in imaging of patients with suspected acute abdominal inflammation. Clin Nucl Med. 1990 Sep;15(9):597-602. doi: 10.1097/00003072-199009000-00001.
- Larson DM, Masters SS, Spiro HM. Medical and surgical therapy in diverticular disease: a comparative study. Gastroenterology. 1976 Nov;71(5):734-7.
- LEIGH JE, JUDD ES, WAUGH JM. Diverticulitis of the colon. Recurrence after apparently adequate segmental resection. Am J Surg. 1962 Jan;103:51-4. doi: 10.1016/0002-9610(62)90012-0. No abstract available.
- Lindahl J, Ristkari SK, Vorne M, Mokka RE. 99m-technetium-HmPAO-labelled leucocytes in the diagnosis of acute colonic diverticulitis. Acta Chir Scand. 1989 Sep;155(9):479-82.
- Ling L, Aberg T. Hartmann procedure. Acta Chir Scand. 1984;150(5):413-7.
- Livermore DM, Carter MW, Bagel S, Wiedemann B, Baquero F, Loza E, Endtz HP, van Den Braak N, Fernandes CJ, Fernandes L, Frimodt-Moller N, Rasmussen LS, Giamarellou H, Giamarellos-Bourboulis E, Jarlier V, Nguyen J, Nord CE, Struelens MJ, Nonhoff C, Turnidge J, Bell J, Zbinden R, Pfister S, Mixson L, Shungu DL. In vitro activities of ertapenem (MK-0826) against recent clinical bacteria collected in Europe and Australia. Antimicrob Agents Chemother. 2001 Jun;45(6):1860-7. doi: 10.1128/AAC.45.6.1860-1867.2001.
- Makela J, Vuolio S, Kiviniemi H, Laitinen S. Natural history of diverticular disease: when to operate? Dis Colon Rectum. 1998 Dec;41(12):1523-8. doi: 10.1007/BF02237300.
- Mazuski JE, Sawyer RG, Nathens AB, DiPiro JT, Schein M, Kudsk KA, Yowler C; Therapeutic Agents Committee of the Surgical Infections Society. The Surgical Infection Society guidelines on antimicrobial therapy for intra-abdominal infections: evidence for the recommendations. Surg Infect (Larchmt). 2002 Fall;3(3):175-233. doi: 10.1089/109629602761624180.
- McConnell EJ, Tessier DJ, Wolff BG. Population-based incidence of complicated diverticular disease of the sigmoid colon based on gender and age. Dis Colon Rectum. 2003 Aug;46(8):1110-4. doi: 10.1007/s10350-004-7288-4.
- McGOWAN FJ, WOLFF WI. Diverticulitis of the sigmoid colon. Gastroenterology. 1952 May;21(1):119-32. No abstract available.
- Morris J, Stellato TA, Lieberman J, Haaga JR. The utility of computed tomography in colonic diverticulitis. Ann Surg. 1986 Aug;204(2):128-32. doi: 10.1097/00000658-198608000-00005.
- Murray JJ, Schoetz DJ Jr, Coller JA, Roberts PL, Veidenheimer MC. Intraoperative colonic lavage and primary anastomosis in nonelective colon resection. Dis Colon Rectum. 1991 Jul;34(7):527-31. doi: 10.1007/BF02049889.
- Nagorney DM, Adson MA, Pemberton JH. Sigmoid diverticulitis with perforation and generalized peritonitis. Dis Colon Rectum. 1985 Feb;28(2):71-5. doi: 10.1007/BF02552645.
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- Papi C, Ciaco A, Koch M, Capurso L. Efficacy of rifaximin in the treatment of symptomatic diverticular disease of the colon. A multicentre double-blind placebo-controlled trial. Aliment Pharmacol Ther. 1995 Feb;9(1):33-9. doi: 10.1111/j.1365-2036.1995.tb00348.x.
- Parks TG. Natural history of diverticular disease of the colon. A review of 521 cases. Br Med J. 1969 Dec 13;4(5684):639-42. doi: 10.1136/bmj.4.5684.639.
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- Perkins JD, Shield CF 3rd, Chang FC, Farha GJ. Acute diverticulitis. Comparison of treatment in immunocompromised and nonimmunocompromised patients. Am J Surg. 1984 Dec;148(6):745-8. doi: 10.1016/0002-9610(84)90429-x.
- Pontari MA, McMillen MA, Garvey RH, Ballantyne GH. Diagnosis and treatment of enterovesical fistulae. Am Surg. 1992 Apr;58(4):258-63.
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- Wexner SD, Dailey TH. The initial management of left lower quadrant peritonitis. Dis Colon Rectum. 1986 Oct;29(10):635-8. doi: 10.1007/BF02560324.
- WELCH CE, ALLEN AW, DONALDSON GA. An appraisal of resection of the colon for diverticulitis of the sigmoid. Ann Surg. 1953 Sep;138(3):332-43. doi: 10.1097/00000658-195313830-00005. No abstract available.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2004年7月1日
研究完成
2007年6月1日
研究注册日期
首次提交
2004年11月29日
首先提交符合 QC 标准的
2004年11月29日
首次发布 (估计)
2004年11月30日
研究记录更新
最后更新发布 (估计)
2006年2月14日
上次提交的符合 QC 标准的更新
2006年2月12日
最后验证
2006年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.