Skip to content

Post Splenectomy Infections After Surgery for Peritoneal Malignancies (OPSI)

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05718726
Acronym
OPSI
Enrollment
300
Registered
2023-02-08
Start date
2021-03-25
Completion date
2031-02-01
Last updated
2024-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection;Post Surg Procedure, Peritoneal Cancer

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.

Interventions

OTHERQuestionnaire, interview or observation study

Questionnaire administered by telephone

Sponsors

Hampshire Hospitals NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of post-splenectomy infections after surgeryPeriod of 5 yearsSelf-reported measure

Secondary

MeasureTime frameDescription
Compliance with prophylactic antibiotic regime post splenectomy as per national guidelinesPeriod of 5 yearsSelf-reported measure

Countries

United Kingdom

Contacts

Primary ContactVictoria Corner
victoria.corner@hhft.nhs.uk01962 824127

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026