History of Changes for Study: NCT05718726

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

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Version	A	B	Submitted Date	Changes
1			January 30, 2023	None (earliest Version on record)

Study Identification


Unique Protocol ID:	SPON-BM-1220
Brief Title:	Post Splenectomy Infections After Surgery for Peritoneal Malignancies (OPSI) (OPSI)
Official Title:	Overwhelming Post-Splenectomy Infections (OPSI) After Cytoreductive Surgery and Hyperthemic Intraperitoneal Chemotherapy: a Prospective Observational Study
Secondary IDs:

Study Status


Record Verification:	January 2023
Overall Status:	Recruiting
Study Start:	March 25, 2021
Primary Completion:	February 1, 2026 [Anticipated]
Study Completion:	February 1, 2031 [Anticipated]

First Submitted:	September 30, 2021
First Submitted that Met QC Criteria:	January 30, 2023
First Posted:	February 8, 2023 [Actual]

Last Update Submitted that Met QC Criteria:	January 30, 2023
Last Update Posted:	February 8, 2023 [Actual]

Sponsor/Collaborators


Sponsor:	Hampshire Hospitals NHS Foundation Trust
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	No

Study Description

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:

Conditions


Conditions:	Post-Splenectomy Infection Peritoneal Cancer
Keywords:

Study Design


Study Type:	Observational
Observational Study Model:	Cohort
Time Perspective:	Retrospective
Biospecimen Retention:
Biospecimen Description:
Enrollment:	300 [Anticipated]
Number of Groups/Cohorts	0

Groups and Interventions


Intervention Details:
	Questionnaire, interview or observation study Questionnaire administered by telephone

Outcome Measures


Primary Outcome Measures:
1.	Number of post-splenectomy infections after surgery [ Time Frame: Period of 5 years ] Self-reported measure
Secondary Outcome Measures:
1.	Compliance with prophylactic antibiotic regime post splenectomy as per national guidelines [ Time Frame: Period of 5 years ] Self-reported measure

Eligibility


Study Population:	Patients of the Peritoneal Malignancy Institute, Hampshire Hospitals Foundation Trust, who have had a splenectomy in conjunction with CRS for any pathology.
Sampling Method:	Non-Probability Sample
Minimum Age:	18 Years
Maximum Age:	79 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
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

Contacts/Locations


Central Contact Person:	Victoria Corner Telephone: 01962 824127 Email: victoria.corner@hhft.nhs.uk
Study Officials:	Brendon Moran Principal Investigator Hampshire Hospitals NHS Foundation Trust
Locations:	United Kingdom, Hampshire
	The Peritoneal Malignancy Institute, Hampshire Hospitals NHS Foundation Trust [Recruiting] Basingstoke, Hampshire, United Kingdom, Rg24 9NN Contact:Contact: Victoria Corner 01962 824127 victoria.corner@hhft.nhs.uk Contact:Principal Investigator: Brendon Moran Contact:Sub-Investigator: Sophie Stanford

IPDSharing


Plan to Share IPD:

References


Citations:
Links:
Available IPD/Information: