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Spanish Registry of Mohs Surgery (REGESMOHS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02310503
Recruitment Status : Completed
First Posted : December 8, 2014
Last Update Posted : May 5, 2020
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Fundación Academia Española de Dermatología

Brief Summary:

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.


Condition or disease Intervention/treatment
Skin Neoplasms Carcinoma, Basal Cell Carcinoma, Squamous Cell Dermatofibrosarcoma Melanoma Histiocytoma, Malignant Fibrous Neoplasms, Adnexal and Skin Appendage Procedure: Mohs surgery

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Study Type : Observational [Patient Registry]
Actual Enrollment : 6000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Years
Official Title: Spanish Registry of Mohs Surgery [Registro Español de Cirugía de Mohs]
Study Start Date : July 1, 2013
Actual Primary Completion Date : February 29, 2020
Actual Study Completion Date : February 29, 2020


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.




Primary Outcome Measures :
  1. Tumor recurrence [ Time Frame: 6 years ]

Secondary Outcome Measures :
  1. Short term outcomes [ Time Frame: 1 month ]
    Bleeding, infection, abnormal scar, necrosis

  2. Use of resources [ Time Frame: During surgery ]
    Need for admission, type of anesthesia, number of surgical steps, participating doctors,time in surgery room.

  3. Impairments of body function and structure [ Time Frame: 6 years ]
    presence of: abnormal scar, ectropion, nostril alteration, oral sphincter incompetence,other



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All consecutive patients considered for Mohs surgery in participating centers.
Criteria

Inclusion Criteria:

  • All consecutive patients considered for Mohs surgery

Exclusion Criteria:

  • Under 18 years-old
  • Legally incompetent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310503


Locations
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Spain
Hospital Universitario de Cruces
Barakaldo, Spain
Hospital del Mar
Barcelona, Spain
Hospital Quirón Teknon
Barcelona, Spain
Hospital Santa Creu i Sant Pau
Barcelona, Spain
Complejo Hospitalario Universitario de Guadalajara
Guadalajara, Spain
Complejo Asistencial Universitario de León
León, Spain
Clínica Quirón
Madrid, Spain
Hospital de la Princesa
Madrid, Spain
Hospital Gregorio Marañon
Madrid, Spain
Hospital La Zarzuela
Madrid, Spain
Hospital Universitario Fundación de Alcorcón
Madrid, Spain
Clínica Universitaria de Navarra
Pamplona, Spain
Complexo Hospitalario Universitario de Santiago
Santiago de Compostela, Spain
Hospital Manises
Valencia, Spain
Instituto Valenciano de Oncología
Valencia, Spain
Sponsors and Collaborators
Fundación Academia Española de Dermatología
Roche Pharma AG
Investigators
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Study Director: Ignacio Garcia-Doval, MD, PhD Research Unit. Academia Española de Dermatologia y Venereologia (Spanish Academy of Dermatology)
Additional Information:
Publications:
Camarero-Mulas C, Delgado Jiménez Y, Sanmartín-Jiménez O, Garcés JR, Rodríguez-Prieto MA, Alonso-Alonso T, Miñano Medrano R, López-Estebaranz JL, de Eusebio Murillo E, Redondo P, Ciudad-Blanco C, Toll-Abelló A, Artola Igarza JL, Allende Markixana I, Suarez Fernández R, Alfaro Rubio A, Alonso Pacheco ML, Vázquez-Veiga H, de la Cueva Dobao P, Ruiz-Salas V, Vilarrasa Rull E, Barchino L, Morales-Gordillo V, Ocerin-Guerra I, Navarro Tejedor R, Hueso L, Mayor Arenal M, Seoane-Pose MJ, Cano-Martinez N, Garcia-Doval I, Descalzo MA; REGESMOHS (Registro Español de Cirugía de Mohs). Mohs micrographic surgery in the elderly: comparison of tumours, surgery and first-year follow-up in patients younger and older than 80 years old in REGESMOHS. J Eur Acad Dermatol Venereol. 2018 Jan;32(1):108-112. doi: 10.1111/jdv.14586. Epub 2017 Oct 5.

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Responsible Party: Fundación Academia Española de Dermatología
ClinicalTrials.gov Identifier: NCT02310503    
Other Study ID Numbers: FAE-MOH-2013-01
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Fundación Academia Española de Dermatología:
Mohs Surgery
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Histiocytoma
Skin Neoplasms
Carcinoma, Basal Cell
Dermatofibrosarcoma
Histiocytoma, Malignant Fibrous
Neoplasms, Adnexal and Skin Appendage
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Site
Skin Diseases
Neoplasms, Basal Cell
Fibrosarcoma
Sarcoma