Spanish Registry of Mohs Surgery (REGESMOHS)

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: Melanoma; Carcinoma, Squamous Cell; Carcinoma, Basal Cell; Skin Neoplasms; Histiocytoma, Malignant Fibrous; Dermatofibrosarcoma; Neoplasms, Adnexal and Skin Appendage
• Intervention / Treatment: Procedure: Mohs surgery

• Study Type: Observational
• Enrollment (Actual): 6000

Contacts and Locations

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 León
  • Madrid, Spain
    • Hospital Gregorio Marañón
  • 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

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

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	6 years

Secondary Outcome Measures

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

Collaborators and Investigators

• 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

General Publications

• Alonso-Alonso T, Redondo-Bellon P, Sanmartin-Jimenez O, de Eusebio-Murillo E, Garcia-Doval I, Rodriguez-Prieto MA. Census of Centers That Perform Mohs' Micrographic Surgery in Spain and Description of Their Activity: A Feasibility Study for the Mohs' Micrographic Surgery Registry of the Foundation of the Spanish Academy of Dermatology and Venereology. Actas Dermosifiliogr. 2015 Nov;106(9):764-6. doi: 10.1016/j.ad.2015.02.014. Epub 2015 Jun 23. No abstract available. English, Spanish.
• Ruiz-Salas V, Garces JR, Minano Medrano R, Alonso-Alonso T, Rodriguez-Prieto MA, Lopez-Estebaranz JL, Sanmartin-Jimenez O, Guillen Barona C, Delgado Jimenez Y, Toll-Abello A, Vargas Diez E, Ciudad Blanco C, Alfaro Rubio A, Allende Markixana I, de Eusebio Murillo E, Manubens-Mercade E, Vazquez-Veiga H, Barchino Ortiz L, Garcia-Doval I, Redondo Bellon P. Description of Patients Undergoing Mohs Surgery in Spain: Initial Report on Data From the Spanish Registry of Mohs Surgery (REGESMOHS). Actas Dermosifiliogr. 2015 Sep;106(7):562-8. doi: 10.1016/j.ad.2015.04.002. Epub 2015 May 28. English, Spanish.
• de Eusebio Murillo E, Martin Fuentes A, Ruiz-Salas V, Garces JR, Minano Medrano R, Lopez-Estebaranz JL, Alonso-Alonso T, Rodriguez-Prieto MA, Delgado Jimenez Y, Morales V, Redondo Bellon P, Manubens-Mercade E, Sanmartin-Jimenez O, Guillen Barona C, Cabeza R, Cano N, Toll-Abello A, Navarro Tejedor R, Artola Igarza JL, Allende Markixana I, Alfaro Rubio A, Ciudad Blanco C, Vazquez-Veiga H, Barchino Ortiz L, Descalzo MA, Garcia-Doval I. Characterization of Surgical Procedures in the Spanish Mohs Surgery Registry (REGESMOHS) for 2013-2015. Actas Dermosifiliogr. 2017 Nov;108(9):836-843. doi: 10.1016/j.ad.2017.04.018. Epub 2017 Aug 9. English, Spanish.
• Camarero-Mulas C, Delgado Jimenez Y, Sanmartin-Jimenez O, Garces JR, Rodriguez-Prieto MA, Alonso-Alonso T, Minano Medrano R, Lopez-Estebaranz JL, de Eusebio Murillo E, Redondo P, Ciudad-Blanco C, Toll-Abello A, Artola Igarza JL, Allende Markixana I, Suarez Fernandez R, Alfaro Rubio A, Alonso Pacheco ML, Vazquez-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 Espanol de Cirugia 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.
• Ruiz-Salas V, Garces JR, Alonso-Alonso T, Rodriguez-Prieto MA, Toll-Abello A, Eusebio Murillo E, Minano R, Lopez-Estebaranz JL, Sanmartin-Jimenez O, Guillen Barona C, Allende Markixana I, Alfaro Rubio A, Delgado Jimenez Y, Navarro R, Barchino Ortiz L, Lazaro Ochaita P, Vilarasa E, Ciudad Blanco C, Vazquez-Veiga H, Artola Igarza JL, Alonso ML, Garcia-Doval I, Descalzo MA, Redondo Bellon P. Description of patients excluded for Mohs surgery after pre-surgical evaluation: data from the Regesmohs Spanish registry. Actas Dermosifiliogr (Engl Ed). 2018 May;109(4):346-350. doi: 10.1016/j.ad.2017.11.008. Epub 2018 Jan 17. English, Spanish.
• Delgado Jimenez Y, Camarero-Mulas C, Sanmartin-Jimenez O, Garces JR, Rodriguez-Prieto MA, Alonso-Alonso T, Minano Medrano R, Lopez-Estebaranz JL, de Eusebio Murillo E, Redondo P, Ciudad-Blanco C, Toll A, Artola Igarza JL, Allende Markixana I, Suarez Fernandez R, Alfaro Rubio A, Alonso Pacheco ML, Vazquez-Veiga H, de la Cueva Dobao P, Ruiz-Salas V, Vilarrasa 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. Differences of Mohs micrographic surgery in basal cell carcinoma versus squamous cell carcinoma. Int J Dermatol. 2018 Nov;57(11):1375-1381. doi: 10.1111/ijd.14223. Epub 2018 Sep 23.

Helpful Links

• Updated descrition of the study (in Spanish)

Study record dates

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: Mohs Surgery
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Neoplasms, Connective Tissue; Sarcoma; Neoplasms, Squamous Cell; Neoplasms, Basal Cell; Neoplasms, Fibrous Tissue; Fibrosarcoma; Neoplasms; Carcinoma; Carcinoma, Squamous Cell; Skin Neoplasms; Carcinoma, Basal Cell; Dermatofibrosarcoma; Histiocytoma, Malignant Fibrous; Histiocytoma; Neoplasms, Adnexal and Skin Appendage
• Other Study ID Numbers: FAE-MOH-2013-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No