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Post Splenectomy Infections After Surgery for Peritoneal Malignancies (OPSI) (OPSI)

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ClinicalTrials.gov Identifier: NCT05718726
Recruitment Status : Recruiting
First Posted : February 8, 2023
Last Update Posted : February 8, 2023
Sponsor:
Information provided by (Responsible Party):
Hampshire Hospitals NHS Foundation Trust

Study Description
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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.

Condition or disease Intervention/treatment
Post-Splenectomy Infection Peritoneal Cancer Other: Questionnaire, interview or observation study

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Overwhelming Post-Splenectomy Infections (OPSI) After Cytoreductive Surgery and Hyperthemic Intraperitoneal Chemotherapy: a Prospective Observational Study
Actual Study Start Date : March 25, 2021
Estimated Primary Completion Date : February 1, 2026
Estimated Study Completion Date : February 1, 2031
Groups and Cohorts
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Intervention Details:
  • Other: Questionnaire, interview or observation study
    Questionnaire administered by telephone

Outcome Measures
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Primary Outcome Measures :
  1. Number of post-splenectomy infections after surgery [ Time Frame: Period of 5 years ]
    Self-reported measure


Secondary Outcome Measures :
  1. Compliance with prophylactic antibiotic regime post splenectomy as per national guidelines [ Time Frame: Period of 5 years ]
    Self-reported measure


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05718726


Contacts
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Contact: Victoria Corner 01962 824127 victoria.corner@hhft.nhs.uk

Locations
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United Kingdom
The Peritoneal Malignancy Institute, Hampshire Hospitals NHS Foundation Trust Recruiting
Basingstoke, Hampshire, United Kingdom, Rg24 9NN
Contact: Victoria Corner    01962 824127    victoria.corner@hhft.nhs.uk   
Principal Investigator: Brendon Moran         
Sub-Investigator: Sophie Stanford         
Sponsors and Collaborators
Hampshire Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Brendon Moran Hampshire Hospitals NHS Foundation Trust
More Information
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Responsible Party: Hampshire Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT05718726    
Other Study ID Numbers: SPON-BM-1220
First Posted: February 8, 2023    Key Record Dates
Last Update Posted: February 8, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Disease Attributes
Pathologic Processes