NCT05544474

Brief Summary

A Delphi consensus to define surgical steps of lymphadenectomy and complete mesocolic excision for radical right colectomy

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
1.2 years until next milestone

Study Start

First participant enrolled

November 28, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2024

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

5 months

First QC Date

September 13, 2022

Last Update Submit

November 27, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    3 months

Study Arms (1)

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.

Other: Delphi questionnaire

Interventions

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.

Expert surgeon on radical right colectomy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Expert surgeon on radical right colectomy

You may qualify if:

  • Experts in the fields of radical right colectomy

You may not qualify if:

  • Panelists who were not able to commit to all rounds of the modified Delphi process

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rome Tor Vergata

Rome, 00133, Italy

Location

Related Links

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 13, 2022

First Posted

September 16, 2022

Study Start

November 28, 2023

Primary Completion

April 30, 2024

Study Completion

August 15, 2024

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations