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Trial Title:
Post Splenectomy Infections After Surgery for Peritoneal Malignancies (OPSI)
NCT ID:
NCT05718726
Condition:
Post-Splenectomy Infection
Peritoneal Cancer
Conditions: Official terms:
Infections
Communicable Diseases
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Other
Intervention name:
Questionnaire, interview or observation study
Description:
Questionnaire administered by telephone
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.
Criteria for eligibility:
Study pop:
Patients of the Peritoneal Malignancy Institute, Hampshire Hospitals Foundation Trust,
who have had a splenectomy in conjunction with CRS for any pathology.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
79 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Peritoneal Malignancy Institute, Hampshire Hospitals NHS Foundation Trust
Address:
City:
Basingstoke
Zip:
Rg24 9NN
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Victoria Corner
Phone:
01962 824127
Email:
victoria.corner@hhft.nhs.uk
Investigator:
Last name:
Brendon Moran
Email:
Principal Investigator
Investigator:
Last name:
Sophie Stanford
Email:
Sub-Investigator
Start date:
March 25, 2021
Completion date:
February 1, 2031
Lead sponsor:
Agency:
Hampshire Hospitals NHS Foundation Trust
Agency class:
Other
Source:
Hampshire Hospitals NHS Foundation Trust
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05718726
