Post Splenectomy Infections After Surgery for Peritoneal Malignancies (OPSI) (OPSI)

• ClinicalTrials.gov Identifier: NCT05718726
• Recruitment Status: Recruiting
• First Posted: February 8, 2023
• Last Update Posted: February 8, 2023
• Sponsor: Hampshire Hospitals NHS Foundation Trust
• Information provided by (Responsible Party): Hampshire Hospitals NHS Foundation Trust

Tracking Information

• First Submitted Date: September 30, 2021
• First Posted Date: February 8, 2023
• Last Update Posted Date: February 8, 2023
• Actual Study Start Date: March 25, 2021
• Estimated Primary Completion Date: February 1, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 30, 2023)

Number of post-splenectomy infections after surgery [ Time Frame: Period of 5 years ]

Self-reported measure

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: January 30, 2023)

Compliance with prophylactic antibiotic regime post splenectomy as per national guidelines [ Time Frame: Period of 5 years ]

Self-reported measure

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Post Splenectomy Infections After Surgery for Peritoneal Malignancies (OPSI)
• Official Title: Overwhelming Post-Splenectomy Infections (OPSI) After Cytoreductive Surgery and Hyperthemic Intraperitoneal Chemotherapy: a Prospective Observational Study
• 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

• Post-Splenectomy Infection
• Peritoneal Cancer

Intervention

Other: Questionnaire, interview or observation study

Questionnaire administered by telephone

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 30, 2023): 300
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 1, 2031
• Estimated Primary Completion Date: February 1, 2026 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 79 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Victoria Corner; 01962 824127; victoria.corner@hhft.nhs.uk

• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT05718726
• Other Study ID Numbers: SPON-BM-1220
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Hampshire Hospitals NHS Foundation Trust
• Original Responsible Party: Same as current
• Current Study Sponsor: Hampshire Hospitals NHS Foundation Trust
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Brendon Moran; Hampshire Hospitals NHS Foundation Trust

• PRS Account: Hampshire Hospitals NHS Foundation Trust
• Verification Date: January 2023