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Recruiting

NCT Number: NCT05718726

Post Splenectomy Infections After Surgery for Peritoneal Malignancies (OPSI)

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.

Recruiting

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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Peritoneal Malignancy Institute, Hampshire Hospitals NHS Foundation Trust

Basingstoke, Hampshire, Rg24 9NN, United Kingdom

Location status: Recruiting

Location contact

Brendon Moran

PRINCIPAL_INVESTIGATOR

Sophie Stanford

SUB_INVESTIGATOR

Victoria Corner

CONTACT

[email protected]

01962 824127

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire, interview or observation study

Other

Questionnaire administered by telephone

Primary outcomes

  1. Number of post-splenectomy infections after surgery

    Time frame: Period of 5 years

    Self-reported measure

Secondary outcomes

  1. Compliance with prophylactic antibiotic regime post splenectomy as per national guidelines

    Time frame: Period of 5 years

    Self-reported measure

Study contacts

Contact information is provided by the study sponsor or research team.

Victoria Corner

CONTACT

[email protected]

01962 824127

Sponsors and collaborators

Lead sponsor

Hampshire Hospitals NHS Foundation Trust

Other

Registry information

Official study title

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

Acronym: OPSI

Important dates

Study start
2021
Primary completion
2026
Study completion
2031
First posted
Feb 8, 2023
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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