Optimization of Communication Between Surgery and Pathology (DigiComSurg)

January 26, 2026 updated by: Claudia Scherl, Heidelberg University

Digitization and Optimization of Communication Between Surgery and Pathology in the Resection of Head and Neck Tumors

The aim of the study is to investigate the extent to which the oncological safety of frozen sections can be improved through visual communication between head and neck surgery and pathology. To date, communication has taken place exclusively by telephone.

In the study photographs and videos of the tumor are taken and transmitted digitally to the pathology department. This provides the pathologist with a better understanding of the tumor bed and the orientation of the specimen.

Likewise, images of the frozen sections are taken in the pathology department, on which the pathologist marks margins that are not resected in sano or are only narrowly in sano. These images are transmitted to the surgeon and provide a more precise understanding of the areas where additional resection may be required.

To ensure patient safety, frozen section results are also communicated by telephone in the usual manner throughout the duration of the project.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

155

Phase

  • Not Applicable

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

  • Germany
      • Mannheim, Germany
        • Universtiy of Heidelberg

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histological proof of malignant head and neck carcinoma by biopsy
  • Planned curative tumor resection with frozen section management

Exclusion Criteria:

  • No curative tumor resection aiming for R0 status
  • Head and neck tumors not assigned to surgical treatment
  • No frozen section management planned during surgery

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Visual digital communication group
The group receives frozen section management supported by digital visual communication between surgery and pathology during head and neck tumor resection.
Procedure: visual description of frozen section results during surgery
This intervention provides more precise information on frozen section results.
No Intervention: traditional telephone communication group
The group recieves frozen section management with conventionel communication via telephone between surgery and pathology during head and neck tumor resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resection status
Time Frame: from day one through study completion, an average of 1 year
To increase the rate of R0 resections
from day one through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Heidelberg University

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 (Actual)

March 5, 2024

Primary Completion (Actual)

February 25, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

January 14, 2026

First Submitted That Met QC Criteria

January 26, 2026

First Posted (Actual)

January 30, 2026

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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