Clinical trial NCT04392245: Proctologic Practice and Covid-19
Official title: A Worldwide Survey on Proctologic Practice During Covid-19 Lockdown
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Proctologic Practice During COVID-19
Keywords: proctology
covid-19
Lead sponsor: Societa Italiana di Chirurgia ColoRettale
Sponsor class: NETWORK
Collaborators: name: Gaetano Gallo
name: Alessandro Sturiale
name: Veronica De Simone
name: Gian Luca Di Tanna
name: Iacopo Giani
name: Ugo Grossi
First posted: 2020-05-18
Enrollment: 1050
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Experts in the field who joined a previous qualitative study\[15\] (N=492) were invited to complete a web survey (participants could be identified only via their valid email address; no other identifying information was collected). The survey link was sent to scientific societies of interest to coloproctologists (i.e. Italian Society of Colorectal Surgery, Russian Association of Coloproctologists, Mediterranean Society of Coloproctology) and disseminated to their members. All collaborators (ProctoLock 2020 Working Group) committed to further recruitment of participants by direct invitation. Participation was entirely voluntary with no compensation offered. Informed consent was obtained from all those agreeing to complete a survey. This study was exempt from review board approval at authors' institutions.

Brief summary: Cross-sectional non-incentivized worldwide web survey.

A worldwide survey of 1050 respondents showed that proctologic practice has been seriously affected by the pandemic. Age, gender and level of hospital preparedness predicted the change of status of surgical and outpatient activities.

The results of our study may inform the development of strategies to reopen activities while protecting frontline healthcare workers.

Detailed description: A 27-item survey (namely, 'ProctoLock 2020') was designed and developed by the authors using an online platform ('Online surveys' \[formerly BOS - Bristol Online Survey\], developed by the University of Bristol) in accordance with the American Association for Public Opinion Research (AAPOR) guidelines and the Checklist for Reporting Results of Internet E-Surveys \[CHERRIES\]

Eligibility criteria: Inclusion Criteria:

Members of renowned scientific societies with an interest in coloproctology

Primary outcomes:
measure: Predictive power of respondents' and hospitals' demographics on the change of status of proctologic surgical and outpatient activities
timeFrame: April 15th to 26th 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: Gallo Gallo
Study officials:
References:
citation: Gallo G, Sturiale A, De Simone V, Mancini S, Di Tanna GL, Milito G, Bianco F, Perinotti R, Giani I, Grossi U; ProctoLock2020 Working Group; Aiello D, Bianco F, Bondurri A, Gallo G, La Torre M, Milito G, Perinotti R, Pietroletti R, Serventi A, Fiorino M, De Simone V, Grossi U, Manigrasso M, Sturiale A, Zaffaroni G, Boffi F, Bellato V, Cantarella F, Deidda S, Marino F, Martellucci J, Milone M, Picciariello A, Bravo AM, Vigorita V, Cunha MF, Leventoglu S, Garmanova T, Tsarkov P, El-Hussuna A, Frontali A, Ioannidis A, Bislenghi G, Shalaby M, Porzio FC, Wu J, Zimmerman D, Elbetti C, Mayol J, Naldini G, Trompetto M, Sammarco G, Santoro GA. Deadlock of proctologic practice in Italy during COVID-19 pandemic: a national report from ProctoLock2020. Updates Surg. 2020 Dec;72(4):1255-1261. doi: 10.1007/s13304-020-00860-0. Epub 2020 Aug 8.