Spanish Registry of Mohs Surgery (REGESMOHS)

May 4, 2020 updated by: Fundación Academia Española de Dermatología

Spanish Registry of Mohs Surgery [Registro Español de Cirugía de Mohs]

REGESMOHS (Registro Español de cirugía de Mohs) aims at describing effectiveness of Mohs surgery, and patient, tumor and technique factors related to adverse events and tumor recurrence.

REGESMOHS is a prospective cohort, including all patients considered for Mohs surgery in participating centers. All consecutive patients are included. The only exclusion criteria are being under 18-years-old or legally incompetent. Pre-planned follow-up is as required by common clinical practice, but at least once a year for the study period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

6000

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

  • Spain
      • Barakaldo, Spain
        • Hospital Universitario de Cruces
      • Barcelona, Spain
        • Hospital del Mar
      • Barcelona, Spain
        • Hospital Santa Creu i Sant Pau
      • Barcelona, Spain
        • Hospital Quiron Teknon
      • Guadalajara, Spain
        • Complejo Hospitalario Universitario de Guadalajara
      • León, Spain
        • Complejo Asistencial Universitario de Leon
      • Madrid, Spain
        • Hospital Gregorio Maranon
      • Madrid, Spain
        • Clinica Quiron
      • Madrid, Spain
        • Hospital de La Princesa
      • Madrid, Spain
        • Hospital Universitario Fundacion de Alcorcon
      • Madrid, Spain
        • Hospital La Zarzuela
      • Pamplona, Spain
        • Clinica Universitaria de Navarra
      • Santiago de Compostela, Spain
        • Complexo Hospitalario Universitario de Santiago
      • Valencia, Spain
        • Instituto Valenciano de Oncologia
      • Valencia, Spain
        • Hospital Manises

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

All consecutive patients considered for Mohs surgery in participating centers.

Description

Inclusion Criteria:

  • All consecutive patients considered for Mohs surgery

Exclusion Criteria:

  • Under 18 years-old
  • Legally incompetent

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
Mohs surgery
Patients treated using Mohs surgery. Other exposures considered include patient characteristics, preoperative care and technical variants.
Procedure: Mohs surgery
A surgical technique used primarily in the treatment of skin neoplasms, especially basal cell or squamous cell carcinoma of the skin. This procedure is a microscopically controlled excision of cutaneous tumors either after fixation in vivo or after freezing the tissue. Serial examinations of fresh tissue specimens are most frequently done.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tumor recurrence
Time Frame: 6 years
6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short term outcomes
Time Frame: 1 month
Bleeding, infection, abnormal scar, necrosis
1 month
Use of resources
Time Frame: During surgery
Need for admission, type of anesthesia, number of surgical steps, participating doctors,time in surgery room.
During surgery
Impairments of body function and structure
Time Frame: 6 years
presence of: abnormal scar, ectropion, nostril alteration, oral sphincter incompetence,other
6 years

Collaborators and Investigators

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

Sponsor

Fundación Academia Española de Dermatología

Collaborators

Roche Pharma AG

Investigators

  • Study Director: Ignacio Garcia-Doval, MD, PhD, Research Unit. Academia Española de Dermatologia y Venereologia (Spanish Academy of Dermatology)

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.

General Publications

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

July 1, 2013

Primary Completion (Actual)

February 29, 2020

Study Completion (Actual)

February 29, 2020

Study Registration Dates

First Submitted

December 1, 2014

First Submitted That Met QC Criteria

December 4, 2014

First Posted (Estimate)

December 8, 2014

Study Record Updates

Last Update Posted (Actual)

May 5, 2020

Last Update Submitted That Met QC Criteria

May 4, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAE-MOH-2013-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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