Patients with cervical carcinoma, stages Ia or Ib1 including IIA1 with small vaginal lesion, who planned to undergo a radical hysterectomy and a total pelvic lymphadenectomy
Conditions
Interventions
Intervention type:PROCEDURE
Name of intervention:
Dose form / Japanese Medical Device Nomenclature:NOT APPLICABLE
Route of administration / Site of application:INTRA-UTERINE
Dose per administration:0
Sponsors
Masaaki Ando
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Patients with cervical carcinoma, stages Ia or Ib1 including IIA1 with small vaginal lesion, who are planned to undergo a radical hysterectomy and a total pelvic lymphadenectomy. 2) Patients should be histologically diagnosed as adenocarcinoma or squamous cell carcinoma or adenosquamous carcinoma. 3) Patients should be proven that the diameter of tumor is less than 4cm and they don't have any enlarged lymph nodes by MRI and CT. 4) Patients age is between 20 - 75 years old. 5) Performance status should be 0 or 1. 6) Patients should not have any presurgical treatment such as radiation therapy, chemotherapy, and surgery excluding conization. 7) Principal organs of patients are working healthy. 8) Patients should provide written informed consent.
Exclusion criteria
Exclusion criteria: Patients, who are diagnosed not to participate in this study by doctors or have some problems such as psychiatric illness, should be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sentinel lymph node detection rate, sensitivity, specificity and negative predictive value | — |
Secondary
| Measure | Time frame |
|---|---|
| Operative time, total blood loss, transfusion, injure to pelvic nerves, postoperative complications that are caused by a total pelvic lymphadenectomy such as lymphedema, lymphocyst, and intestinal obstruction | — |
Countries
Japan
Contacts
Public ContactRyoko Ishii
Kurashiki Medical Center
Outcome results
None listed