ARCO: a study to understand Abdominal Rates of COronavirus infection [COVID-19]
Research type
Research Study
Full title
A study of the prevalence of SARS-CoV-2 RNA in peritoneal fluid and lower genital tract sampling from patients undergoing surgery
IRAS ID
284485
Contact name
Richard John Edmondson
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Duration of Study in the UK
0 years, 4 months, 0 days
Research summary
Introduction\nThe safety of laparoscopic surgery and lower genital tract procedures in gynaecological oncology during the COVID pandemic is uncertain. The possibility that virus particles in the peritoneal cavity and lower genital tract could be transmitted as an aerosol or within a surgical plume has not been adequately investigated.\nHere we will leverage the high caseload of a large NHS trust to sample patients undergoing abdominal surgery and lower genital tract instrumentation to investigate the prevalence of SARS-CoV-2 RNA in bodily fluids in patients both presumed to be negative for COVID and those known to be positive for COVID.\n\nMethodology\nWe will sample 100 patients undergoing abdominal surgery (including gynaecological, colorectal and obstetric procedures) and/or instrumentation of the lower genital tract (including colposcopy and hysteroscopy). Samples will undergo RT-PCR for SARS-CoV-2.\nPatients will be stratified into known COVID positive patients and presumed negative patients. The co primary endpoints of the study will be \n• prevalence of SARS-CoV-2 RNA in peritoneal fluid of patients presumed to be negative for COVID19\n• prevalence of SARS-CoV-2 RNA in lower genital tract fluid of patients presumed to be negative for COVID19\n\nSecondary endpoints will include the prevalence of SARS-CoV-2 RNA in peritoneal and lower genital tract fluid from patients known to be positive for COVDID19\n\nLikely Impact\nThis work will inform the debate regarding the safety of laparoscopic surgery in gynaecological oncology, specifically it will help answer the question of whether minimal access procedures are safe in patients presumed to be COVID negative. \n [Study relying on COPI notice]
REC name
South West - Frenchay Research Ethics Committee
REC reference
20/SW/0088
Date of REC Opinion
15 May 2020
REC opinion
Favourable Opinion