Spanish Registry of Mohs Surgery

Melanoma Clinical Trial

— REGESMOHS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02310503
• Other study ID #: FAE-MOH-2013-01
• Status: Completed
• Start date: July 1, 2013
• Est. completion date: February 29, 2020

Study information

• Verified date: May 2020
• Source: Fundación Academia Española de Dermatología
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6000
• Est. completion date: February 29, 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All consecutive patients considered for Mohs surgery

Exclusion Criteria:

• Under 18 years-old

• Legally incompetent

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Basal Cell
• Carcinoma, Squamous Cell
• Dermatofibrosarcoma
• Histiocytoma
• Histiocytoma, Malignant Fibrous
• Melanoma
• Neoplasms
• Neoplasms, Adnexal and Skin Appendage
• Skin Neoplasms

Intervention

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.

Locations

Country	Name	City	State
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

Sponsors (2)

Lead Sponsor	Collaborator
Fundación Academia Española de Dermatología	Roche Pharma AG

Country where clinical trial is conducted

Spain, 

References & Publications (6)

Alonso-Alonso T, Redondo-Bellon P, Sanmartín-Jiménez O, de Eusebio-Murillo E, García-Doval I, Rodríguez-Prieto MÁ. 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. English, Spanish. — View Citation

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. — View Citation

de Eusebio Murillo E, Martín Fuentes A, Ruiz-Salas V, Garcés JR, Miñano Medrano R, López-Estebaranz JL, Alonso-Alonso T, Rodríguez-Prieto MÁ, Delgado Jiménez Y, Morales V, Redondo Bellón P, Manubens-Mercadé E, Sanmartín-Jiménez O, Guillén Barona C, Cabeza R, Cano N, Toll-Abelló A, Navarro Tejedor R, Artola Igarza JL, Allende Markixana I, Alfaro Rubio A, Ciudad Blanco C, Vázquez-Veiga H, Barchino Ortiz L, Descalzo MA, García-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. — View Citation

Delgado Jiménez Y, Camarero-Mulas C, Sanmartín-Jiménez O, Garcés JR, Rodríguez-Prieto MÃ, Alonso-Alonso T, Miñano Medrano R, López-Estebaranz JL, de Eusebio Murillo E, Redondo P, Ciudad-Blanco C, Toll 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 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. — View Citation

Ruiz-Salas V, Garcés JR, Alonso-Alonso T, Rodríguez-Prieto MA, Toll-Abelló A, Eusebio Murillo E, Miñano R, López-Estebaranz JL, Sanmartín-Jiménez O, Guillén Barona C, Allende Markixana I, Alfaro Rubio A, Delgado Jiménez Y, Navarro R, Barchino Ortiz L, Lázaro Ochaita P, Vilarasa E, Ciudad Blanco C, Vázquez-Veiga H, Artola Igarza JL, Alonso ML, García-Doval I, Descalzo MA, Redondo Bellón P. Description of patients excluded for Mohs surgery after pre-surgical evaluation: data from the Regesmohs Spanish registry. Actas Dermosifiliogr. 2018 May;109(4):346-350. doi: 10.1016/j.ad.2017.11.008. Epub 2018 Jan 17. English, Spanish. — View Citation

Ruiz-Salas V, Garcés JR, Miñano Medrano R, Alonso-Alonso T, Rodríguez-Prieto MÁ, López-Estebaranz JL, Sanmartín-Jiménez O, Guillén Barona C, Delgado Jiménez Y, Toll-Abelló A, Vargas Diez E, Ciudad Blanco C, Alfaro Rubio A, Allende Markixana I, de Eusebio Murillo E, Manubens-Mercadé E, Vázquez-Veiga H, Barchino Ortiz L, García-Doval I, Redondo Bellón 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. — View Citation

Outcome

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

External Links

•   Updated descrition of the study (in Spanish)