Post Splenectomy Infections After Surgery for Peritoneal Malignancies (OPSI)

NCT05718726 | Recruiting

• 1 other identifier: SPON-BM-1220
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection;Post Surg Procedure; Peritoneal Cancer

Outcome Measures

Primary Outcomes (1)

• Number of post-splenectomy infections after surgery

  Self-reported measure

  Period of 5 years

Secondary Outcomes (1)

• Compliance with prophylactic antibiotic regime post splenectomy as per national guidelines

  Period of 5 years

Interventions

Questionnaire, interview or observation study OTHER

Questionnaire administered by telephone

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 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

You may not qualify if:

• \- Patients who are \<18 and \>80 Patients who do not provide informed consent Patients on immunosuppression therapy

Sponsors & Collaborators

• Hampshire Hospitals NHS Foundation Trust: lead

Study Sites (1)

The Peritoneal Malignancy Institute, Hampshire Hospitals NHS Foundation Trust

Basingstoke, Hampshire, Rg24 9NN, United Kingdom

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires; Interviews as Topic

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Brendon Moran

  Hampshire Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria Corner

CONTACT

01962 824127; victoria.corner@hhft.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: February 8, 2023
• Study Start: March 25, 2021
• Primary Completion: February 1, 2026
• Study Completion (Estimated): February 1, 2031
• Last Updated: November 27, 2024

Record last verified: 2024-11

Locations

GB (1)