Mohs Versus Traditional Surgery - Basal-Cell Carcinomas (BCC)

NCT00699829 | Unknown DMC

• 1 other identifier: P070158
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

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 located in the high-risk zone (nose, peri-orificial areas of the head) and with diameter larger than 1 cm. The effectiveness will be measured by the rate of recurrence at 5 years (as measured by the prolongation of the follow-up after the surgical procedure). The utility from the patient point of view will be evaluated by a specific dermatologic quality of life questionnaire (Skindex) and by a generic questionnaire (Euroqol 5D), supplemented by a questionnaire of satisfaction of the care (Attkisson). The economic perspectives studied will be those of the hospital, of the payer and of the society. Direct medical costs will be evaluated by micro-costing. The main production factors implied in the realization of one CMM or one traditional surgery in dermatology/surgery and anatomopathology wards will be identified, counted, and developed. The measuring units will be the estimate of the time devoted to each individual procedure, reported to the total activity of each ward and the wages of the various categories of personnel implied, and the unit costs in consumable and redeemable material, reported to their utilisation factor. The hospital indirect costs will be estimated by the financial services of the hospitals. Accrual of 150 CMM and 300 traditional excisions will be performed within a two year period of time.

Conditions

Carcinoma, Basal Cell

Outcome Measures

Primary Outcomes (1)

• Cost-utility ratio

  2 years

Secondary Outcomes (1)

• 2 and 5 years survival

  2 & 5 yrs

Study Arms (2)

1

Mohs' micrographic surgery (MMS)

2

Conventional surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients de services de dermatologie et/ou chir plastique

You may qualify if:

• Age ≥ 18
• Histologically proved cutaneous BCC
• Categorized as "bad prognostic" according to the 2004 recommendations of ANAES
• morpheaform or ill-limited clinical forms and histologically aggressive forms (morpheaform, micronodular, infiltrating, squamous differentiation) OR
• already recurred BCC (except for superficial BCCs) OR
• nodular BCCs from the high-risk zone (nose and peri-orificial areas of the head) and with diameter larger than 1 cm.
• Life expectancy greater than 3 years according to the investigator's opinion.
• Patient being informed and having signed the consent to participate to the study

You may not qualify if:

• History of X-ray therapy in the territory of the BCC
• Counter-indication to surgery
• Life expectancy \< 3 years
• superficial BCCs, even if recurred
• Patient being unable to attend future follow-up visits
• Patient with severe cognitive impairment
• Patient not affiliated to a social security regimen

Sponsors & Collaborators

• Hospital Ambroise Paré Paris: lead

Study Sites (1)

Hôpital Ambroise Paré

Boulogne, 92100, France

RECRUITING

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Study Officials

• Philippe SAIAG

  Hospital Ambroise Paré Paris

  PRINCIPAL INVESTIGATOR

• Jean-Marie SERVANT

  Hôpital Saint Louis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pr Philippe SAIAG

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 6, 2008
• First Posted: June 18, 2008
• Study Start: June 1, 2008
• Last Updated: February 16, 2009

Record last verified: 2009-02

Locations

FR (1)