Clinical Trial: Mohs Versus Traditional Surgery - Basal-Cell Carcinomas (BCC)

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

Official Title: Comparative Medico-Economic Evaluation of Micrographic Mohs Surgery (MMS) and Traditional Surgical Excision With Immediate or Differed Reconstruction to Treat High Recurrence Risk Mohs' micrographic surgery (MMS) is a treatment of choice for high recurrence risk basal-cell carcinomas (BCC). Realized under local anaesthesia, it induces very low recurrence rates and spares unnecessary excision of intact surrounding tissues, thus decreasing the needs for flaps, skin grafts, and allows immediate reconstruction…. Its disadvantages are mainly: need for a significant training of the operator, the pathologist and the non-medical personnel; longer duration of the procedure, with higher a priori costs, and constraints for the patient related to the duration of the intervention. Traditional surgical excision with immediate or differed reconstruction is the technique of reference. Provided that re-excisions are performed as long as previous ones do not guarantee free margins, it gives good results. Its real costs are poorly known and can be enhanced by several considerations: multiplicity of the operational acts if the initial excision is insufficient, more complex reconstruction procedures, duration of post-operative dressings, ….

The investigators' objective is to know the costs of the surgical treatment of the high risk CBC, comparing the CMM with the surgical excision with immediate or differed reconstruction, along with its effectiveness defined by the absence of recurrence. by its impact on the quality of life of the patient. It is a prospective, multicentric, comparative, not randomized, open, cohort study, of the type "here and elsewhere". Patients with high-risk CBC, as defined by the French ANAES Guidelines (2004), will be included:

• clinically morpheaform aspect or ill-limited margins, aggressive histological forms;
• already recurred BCC (except for superficial BCCs));
• nodular BCC
  

  Detailed Summary:
  Sponsor: Hospital Ambroise Paré Paris
  

  Current Primary Outcome: Cost-utility ratio [ Time Frame: 2 years ]
  
  

  Original Primary Outcome: Same as current
  
  

  Current Secondary Outcome: 2 and 5 years survival [ Time Frame: 2 & 5 yrs ]
  
  

  Original Secondary Outcome: Same as current
  
  Information By: Hospital Ambroise Paré Paris
  

  Dates:
  Date Received: May 6, 2008
  Date Started: June 2008
  Date Completion:
  Last Updated: February 12, 2009
  Last Verified: February 2009