Post Splenectomy Infections After Surgery for Peritoneal Malignancies (OPSI)

Peritoneal Cancer Clinical Trial

— OPSI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05718726
• Other study ID #: SPON-BM-1220
• Status: Recruiting
• Start date: March 25, 2021
• Est. completion date: February 1, 2031

Study information

• Verified date: January 2023
• Source: Hampshire Hospitals NHS Foundation Trust
• Contact: Victoria Corner
• Phone: 01962 824127
• Email: victoria.corner[@]hhft.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 1, 2031
• Est. primary completion date: February 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Peritoneal Cancer

Intervention

Other:
• Questionnaire, interview or observation study
Questionnaire administered by telephone

Locations

Country	Name	City	State
United Kingdom	The Peritoneal Malignancy Institute, Hampshire Hospitals NHS Foundation Trust	Basingstoke	Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Hampshire Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of post-splenectomy infections after surgery	Self-reported measure	Period of 5 years
Secondary	Compliance with prophylactic antibiotic regime post splenectomy as per national guidelines	Self-reported measure	Period of 5 years