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临床试验/NCT05718726
NCT05718726招募中不适用

Overwhelming Post-Splenectomy Infections (OPSI) After Cytoreductive Surgery and Hyperthemic Intraperitoneal Chemotherapy: a Prospective Observational Study

Hampshire Hospitals NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年3月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
Number of post-splenectomy infections after surgery

研究概览

简要总结

The spleen is involved in maintaining immunity and plays an important role in the elimination of encapsulated bacteria and parasites. Patients who undergo splenectomy in conjunction with complete CRS for peritoneal malignancy are at risk of overwhelming post-splenectomy infections post-operatively. These patients are therefore administered vaccinations to lower the risk of infections but as they do not completely eliminate the risk, patients are also prescribed prophylactic antibiotics without clear evidence that they are useful in preventing OPSI. The use of prophylactic antibiotics is not without risk with potential short and long-term risks including resistance, interaction with other medication, clostridium difficile infections, fungal infections, other changes to the microbiome and cost. This study will investigate the incidence of OPSI post splenectomy and assess compliance with prophylactic antibiotics. This is an observational study where consented patients will be telephoned at fixed time points which are 1,6,12 weekly and 6 monthly for a period of five years post-operatively. As part of routine care patients will be telephoned by the clinical nurse specialist at weeks 1,6 and 12. In addition to this the research nurse will telephone the patient 6 monthly for a period of 5 years and complete a questionnaire. The research nurse will complete the questionnaire during each telephone call and this should not take more than 20 minutes. At the start of the telephone call, consent will be confirmed each time and the research nurse will check that the patient is still happy to participate before going ahead.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged >18 and <80 years Patients capable of providing informed consent Patients who have a splenectomy in conjunction with complete cytoreductive surgery (CRS) for any pathology

排除标准

  • Patients who are <18 and >80 Patients who do not provide informed consent Patients on immunosuppression therapy

结局指标

主要结局

Number of post-splenectomy infections after surgery

时间窗: Period of 5 years

Self-reported measure

次要结局

  • Compliance with prophylactic antibiotic regime post splenectomy as per national guidelines(Period of 5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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