Complications and Recurrences After Mohs Micrographic Surgery and Slow Mohs

Active, not recruiting

• Conditions: Complication of Surgical Procedure; Complication; Recurrent Disease; Lentigo Maligna; Recurrence; Basal Cell Carcinoma; Lentigo Maligna Melanoma; Skin Cancer; Complication,Postoperative; Cutaneous Squamous Cell Carcinoma
• Interventions: Procedure: Mohs surgery; Procedure: Slow Mohs surgery

• Registration Number: NCT06014619
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

Mohs micro-graphic surgery (Mohs) is a tissue-sparing, surgical treatment for different types of skin cancer (e.g. basal cell carcinoma, squamous cell carcinoma, lentigo maligna (melanoma). It is a procedure performed with frozen sections. Slow Mohs, a variant of micro-graphic surgery, is performed by formalin fixation and paraffin-embedded sections. Both in Mohs and Slow Mohs tumor margins are assessed to achieve complete removal. This study aims to investigate the clinical presentation and outcomes (i.e. complications and recurrence rates) in patients treated with Mohs or Slow Mohs in the dermatology department of the Maastricht University Medical Center+ in Maastricht, the Netherlands.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-01
• Study First Submitted: 2023-08-15
• Study First Submitted QC: 2023-08-23
• Study First Posted: 2023-08-28
• Primary Completion: 2024-02-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-04
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• patients with a cutaneous lesion with an indication for Mohs micrographic surgery or Slow Mohs
• patients who received a treatment with either Mohs or Slow Mohs between 1 july 2017 and 1 july 2023 at the dermatology department of the Maastricht University Medical Center+.

Exclusion Criteria

• None.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mohs Micrographic Surgery	Mohs surgery	Patients treated with Mohs Micrographic Surgery in the dermatology department of Maastricht University Medical Center +, Maastricht, the Netherlands
Slow Mohs	Slow Mohs surgery	Patients treated with Slow Mohs in the dermatology department of Maastricht University Medical Center +, Maastricht, the Netherlands

Primary Outcome Measures

Name	Time	Method
Incidence of complications	Within 1 month after completion of the surgical intervention.	The incidence of complications after Mohs and Slow Mohs, expressed as absolute numbers and percentages.
Incidence of recurrence	Up to 5 year after completion of the surgical intervention.	The incidence of complications after Mohs and Slow Mohs, expressed as absolute numbers and percentages. Recurrence is defined as disease relapse after completion of treatment.

Secondary Outcome Measures

Name	Time	Method
Hazard ratio of predisposing factors for complications	Within 1 month after completion of the surgical intervention.	Predisposing factors (patient- and tumor characteristics) for complications after Mohs and Slow Mohs, expressed in Hazard Ratio's and 95% confidence intervals. It is not possible to define the predisposing factors in advance, because this is currently unknown. We hypothesize the presence of diabetes, tobacco use and medication use to be predisposing factors for complications.
Hazard ratio of predisposing factors for recurrence	Up to 5 year after completion of the surgical intervention.	Predisposing factors (patient- and tumor characteristics) for recurrences after Mohs and Slow Mohs, expressed in Hazard Ratio's and 95% confidence intervals. It is not possible to define the predisposing factors in advance, because this is currently unknown. We hypothesize incomplete treatment, worse prognostic tumor factors (Stage III of IV, presence of perineural invasion or lymphovascular invasion) to be predisposing factors for recurrence.

Trial Locations

Locations (1)

Maastricht University Medical Center+; 🇳🇱 Maastricht, Netherlands