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CompletedNCT04392245PROCTOLOCKUpdated May 18, 2020

Proctologic Practice and Covid-19

An observational study in Proctologic Practice During COVID-19, sponsored by Societa Italiana di Chirurgia ColoRettale. Completed at 1 site in Italy. Per ClinicalTrials.gov, last updated 2020-05-18.

Sponsored by Societa Italiana di Chirurgia ColoRettale · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
1,050
Sex
All
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Study 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.

Read the 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]

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Conditions studied

  • Proctologic Practice During COVID-19

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Keywords

  • proctology
  • covid-19
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In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 1,050 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Societa Italiana di Chirurgia ColoRettale is the lead sponsor of 15 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Eligibility criteria

Inclusion Criteria:

Members of renowned scientific societies with an interest in coloproctology

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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
1,050 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Predictive power of respondents' and hospitals' demographics on the change of status of proctologic surgical and outpatient activities

    Time frame: April 15th to 26th 2020

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Study locations

1 site
  • Gallo Gallo
    Catanzaro, 88100, Italy
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References and documents

Publications

  • 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. PubMed 32770466 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04392245
Lead sponsor
Societa Italiana di Chirurgia ColoRettale
Collaborators
Gaetano Gallo, Alessandro Sturiale, Veronica De Simone, Gian Luca Di Tanna, Iacopo Giani, Ugo Grossi
Responsible party
Sponsor
First posted
May 18, 2020
Start date
Apr 15, 2020
Primary completion
Apr 26, 2020
Completion
Apr 26, 2020
Last update
May 18, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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