Proctologic Practice During COVID-19PROCTOLOCKNCT04392245
Proctologic Practice and Covid-19
An observational study of Proctologic Practice During COVID-19, run by Societa Italiana di Chirurgia ColoRettale at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Proctologic Practice During COVID-19
- How many people
- 1,050 participants
- Where
- 1 siteItaly
- Study dates
- 15 Apr 2020to 26 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Members of renowned scientific societies with an interest in coloproctology
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Worldwide Survey on Proctologic Practice During Covid-19 Lockdown
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]
- Conditions
- Proctologic Practice During COVID-19
- Keywords
- proctology, covid-19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive power of respondents' and hospitals' demographics on the change of status of proctologic surgical and outpatient activities
Measured: April 15th to 26th 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start15 Apr 2020
- Primary completion26 Apr 2020
- Study completion26 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Proctologic Practice During COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,050 participants (actual)
Sponsor and investigators
- Lead sponsor
- Societa Italiana di Chirurgia ColoRettale
- Sponsor type
- Research network
- Collaborators
- Gaetano Gallo, Alessandro Sturiale, Veronica De Simone, Gian Luca Di Tanna, Iacopo Giani, Ugo Grossi
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04392245
- Sponsor's protocol ID
- 1.0
- Acronym
- PROCTOLOCK
- Status last verified
- May 2020
- First submitted
- 15 May 2020
- Last updated
- 18 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Worldwide Survey on Proctologic Practice During Covid-19 Lockdown
- ClinicalTrials.gov ID
- NCT04392245
- Acronym / sponsor ID
- PROCTOLOCK / 1.0
- Conditions
- Proctologic Practice During COVID-19
- Keywords
- proctology, covid-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,050 participants (actual)
- Lead sponsor
- Societa Italiana di Chirurgia ColoRettaleResearch network
- Collaborators
- Gaetano Gallo, Alessandro Sturiale, Veronica De Simone, Gian Luca Di Tanna, Iacopo Giani, Ugo Grossi
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 26 Apr 2020 (actual)
- Study completion
- 26 Apr 2020 (actual)
- First posted
- 18 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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]
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Members of renowned scientific societies with an interest in coloproctology
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2020.
- Derived from this study: PubMed 32770466Gallo 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Proctologic Practice During COVID-19, run by Societa Italiana di Chirurgia ColoRettale at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04392245, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2020.