Clinical trial NCT05718726: Post Splenectomy Infections After Surgery for Peritoneal Malignancies (OPSI)
Official title: Overwhelming Post-Splenectomy Infections (OPSI) After Cytoreductive Surgery and Hyperthemic Intraperitoneal Chemotherapy: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infection;Post Surg Procedure
Peritoneal Cancer
Lead sponsor: Hampshire Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of the Peritoneal Malignancy Institute, Hampshire Hospitals Foundation Trust, who have had a splenectomy in conjunction with CRS for any pathology.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

- 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

Exclusion Criteria:

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

Primary outcomes:
measure: Number of post-splenectomy infections after surgery
timeFrame: Period of 5 years
Secondary outcomes:
measure: Compliance with prophylactic antibiotic regime post splenectomy as per national guidelines
timeFrame: Period of 5 years
Other outcomes:
Locations:
city: Basingstoke
country: United Kingdom
facility: The Peritoneal Malignancy Institute, Hampshire Hospitals NHS Foundation Trust
state: Hampshire
Study officials:
affiliation: Hampshire Hospitals NHS Foundation Trust
name: Brendon Moran
role: PRINCIPAL_INVESTIGATOR
References: