At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Questionnaire, interview or observation study (other)
- How long the study runs
- Study runs about 119 months (dates as stated)
- About the drug or intervention
- Questionnaire, interview or observation study — other: Questionnaire administered by telephone
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years to 79 Years
- Who
- All
- Number of participants
- 300
- Started
- 2021-03-25
- Last checked
- 2024-11
Plain English Summary
What is this study?
- • Testing a new treatment for infection;post surg procedure
- • Clinical study - 300 participants
- • The spleen is involved in maintaining immunity and plays an important role in the elimination of encapsulated bacteria and parasites
Who can take part?
- • Ages 18 Years to 79 Years
- • Diagnosed with infection;post surg procedure
Where?
- • Basingstoke - The Peritoneal Malignancy Institute, Hampshire Hospitals NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 79 Years
- Who can join: All genders
What the study is looking for
- ✓\- Patients aged \>18 and \<80 years Patients capable of providing agreement to take part Patients who have a splenectomy...
Who cannot take part
- ✗\- Patients who are \<18 and \>80 Patients who do not provide agreement to take part Patients on immunosuppression therapy
See the full criteria
Where Is This Study? (1 UK site)
The Peritoneal Malignancy Institute, Hampshire Hospitals NHS Foundation Trust
Basingstoke Rg24 9NN, United Kingdom
How to Get in Touch
Victoria Corner
Sponsor contactCONTACT