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Post Splenectomy Infections After Surgery for Peritoneal Malignancies (OPSI)

NCT ID: NCT05718726

Last Updated: 2024-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-25

Study Completion Date

2031-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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Infection;Post Surg Procedure Peritoneal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Questionnaire, interview or observation study

Questionnaire administered by telephone

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hampshire Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brendon Moran

Role: PRINCIPAL_INVESTIGATOR

Hampshire Hospitals NHS Foundation Trust

Locations

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The Peritoneal Malignancy Institute, Hampshire Hospitals NHS Foundation Trust

Basingstoke, Hampshire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Victoria Corner

Role: CONTACT

[email protected]
01962 824127

Facility Contacts

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Victoria Corner

Role: primary

[email protected]
01962 824127

Other Identifiers

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SPON-BM-1220

Identifier Type: -

Identifier Source: org_study_id