Colon CancerNCT05544474
Definition of Surgical Technique of Lymphadenectomy and Complete Mesocolon Excision for Radical Right Colectomy: a Delphi Consensus
An observational study of Colon Cancer, run by University of Rome Tor Vergata at 1 site in Italy.
Trial summary
A Delphi consensus to define surgical steps of lymphadenectomy and complete mesocolic excision for radical right colectomy Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Delphi questionnaire
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 28 Nov 2023to 15 Aug 2024
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Expert surgeon on radical right colectomy
Who may be able to join
- Experts in the fields of radical right colectomy
Who cannot join
- Panelists who were not able to commit to all rounds of the modified Delphi process
Trial locations and contacts
1 site in 1 country.
About this study
A Delphi consensus to define surgical steps of lymphadenectomy and complete mesocolic excision for radical right colectomy
- Conditions
- Colon Cancer
- Being tested
- Delphi questionnaire
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delphi questionnaireOther
An invitation email, including a link to the survey, will be sent to the panel of experts in the field of radical right colectomy. The Delphi questionnaire will be administered via www.surveymonkey.com.
In the first survey, panel members will agree on surgical steps, definition of surgical steps and nomenclature for radical right colectomy In subsequent surveys, panel expert will agree on a common definition, nomenclature and reporting for right colectomy. Multiple rounds will be conducted until consensus is reached. After each round, the study team will calculate the agreement and distribution of responses. Likert responses will be dichotomized with positive values indicating agreement and neutral or negative values indicating disagreement.
For the questions that do not reach a consensus of more than 70% in the first round or need further explanation, additional rounds of the survey may be performed.
| Study group | Role | What they receive |
|---|---|---|
| Expert surgeon on radical right colectomy | Expert surgeon on radical right colectomy com pricing corresponding author/senior author from paper included in a preliminary systematic review on this topic Sica GS, Vinci D, Siragusa L, Sensi B, Guida AM, Bellato V, García-Granero Á, Pellino G. Definition and reporting of lymphadenectomy and complete mesocolic excision for radical right colectomy: a systematic review. Surg Endosc. 2022 Sep 12. doi: 10.1007/s00464-022-09548-5. Receives: Other: Delphi questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of consensus
The level of agreement for all statements achieving consensus from the expert panel; consensus is predefined as ≥ 80% of the panel rating a given statement
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start28 Nov 2023 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completion15 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Sigismondo Sica, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05544474
- Sponsor's protocol ID
- 09/22
- Status last verified
- Nov 2023
- First submitted
- 13 Sep 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Definition of Surgical Technique of Lymphadenectomy and Complete Mesocolon Excision for Radical Right Colectomy: a Delphi Consensus
- ClinicalTrials.gov ID
- NCT05544474
- Acronym / sponsor ID
- 09/22
- Conditions
- Colon Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- 28 Nov 2023 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 15 Aug 2024 (estimated)
- First posted
- 16 Sep 2022 (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.
A Delphi consensus to define surgical steps of lymphadenectomy and complete mesocolic excision for radical right colectomy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Expert surgeon on radical right colectomy | – | Other: Delphi questionnaireExpert surgeon on radical right colectomy com pricing corresponding author/senior author from paper included in a preliminary systematic review on this topic Sica GS, Vinci D, Siragusa L, Sensi B, Guida AM, Bellato V, García-Granero Á, Pellino G. Definition and reporting of lymphadenectomy and complete mesocolic excision for radical right colectomy: a systematic review. Surg Endosc. 2022 Sep 12. doi: 10.1007/s00464-022-09548-5. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Expert surgeon on radical right colectomy
Key inclusion criteria (1 listed)
- Experts in the fields of radical right colectomy
Key exclusion criteria (1 listed)
- Panelists who were not able to commit to all rounds of the modified Delphi process
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delphi questionnaireAn invitation email, including a link to the survey, will be sent to the panel of experts in the field of radical right colectomy. The Delphi questionnaire will be administered via www.surveymonkey.com. In the first survey, panel members will agree on surgical steps, definition of surgical steps and nomenclature for radical right colectomy In subsequent surveys, panel expert will agree on a common definition, nomenclature and reporting for right colectomy. Multiple rounds will be conducted until consensus is reached. After each round, the study team will calculate the agreement and distribution of responses. Likert responses will be dichotomized with positive values indicating agreement and neutral or negative values indicating disagreement. For the questions that do not reach a consensus of more than 70% in the first round or need further explanation, additional rounds of the survey may be performed. | Other | Expert surgeon on radical right colectomy |
Primary outcome
Degree of consensus
Time frame: 3 months
The level of agreement for all statements achieving consensus from the expert panel; consensus is predefined as ≥ 80% of the panel rating a given statement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Sica GS, Vinci D, Siragusa L, et al. Definition and reporting of lymphadenectomy and complete mesocolic excision for radical right colectomy: a systematic review. Surg Endosc. 2022 Sep 12Link provided by the sponsor.
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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 Colon Cancer, run by University of Rome Tor Vergata 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 1 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: status not confirmed, as of the sponsor's last update on 29 Nov 2023. 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?
Results are not available in the source record.
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?
Degree of consensus (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2023.