Patients with early cervical cancer are usually treated with radical hysterectomy + pelvic lymph-node dissection. The study randomizes patients in 2 arms. The control arm is the classical surgical treatment including identification of the sentinel nodes, full pelvic lymph-node dissection and radical hysterectomy. The experimental arm is only sentinel node identification + radical hysterectomy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
267
identification of sentinel nodes + full pelvic lymph-node dissection
only identification of sentinel nodes (without pelvic lymph-node dissection)
Service de Gynécologie, Hôpital Femme Mère Enfant
Bron, France
Number of Participants with complications observed in the 2 arms during the per and post-operative period up to 6 months
Time frame: 6 months after surgery
Score of the questionnaire of quality of life at 30 days, 3 months and 6 months after surgery
Time frame: 30 days, 3 months and 6 months after surgery
the costs of both studied strategies
Time frame: At the surgery until 6 months
the detection rate of the sentinel node technique in the 2 arms
Time frame: Day 1
the false negative rate in the control arm
Time frame: Day 1
the sites of recurrence for each strategy
Time frame: Day 1
Number of patients without 3 years-recurrence for each strategy
Time frame: 3 years after surgery
Number of patient treated by radio chemotherapy because of the presence of micrometastases in the sentinel node
Time frame: 30 days, 3 months and 6 months after surgery
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