Definition of Surgical Technique of Lymphadenectomy and Complete Mesocolon Excision for Radical Right Colectomy: a Delphi Consensus

November 27, 2023 updated by: Giuseppe Sigismondo Sica, University of Rome Tor Vergata
A Delphi consensus to define surgical steps of lymphadenectomy and complete mesocolic excision for radical right colectomy

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00133
        • University of Rome Tor Vergata

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Expert surgeon on radical right colectomy

Description

Inclusion Criteria:

  • Experts in the fields of radical right colectomy

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rome Tor Vergata

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 28, 2023

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

August 15, 2024

Study Registration Dates

First Submitted

September 13, 2022

First Submitted That Met QC Criteria

September 13, 2022

First Posted (Actual)

September 16, 2022

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09/22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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