cervical cancer trachelectomy
Conditions
Interventions
operation
Sponsors
Togami Shinichi
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Cervical cancer ( histologically confirmed ) 2. CIS- Stage 1B 1 1 ) Simple trachelectomy i ) For squamous cell carcinoma: stump positive of conization, recurrence after conization and Stage 1A 1 inappropriate for follow-up. ii ) For adenocarcinoma: stump positive of conization inappropriate for follow-up and Stage 1A 2 ) Semiradical trachelectomy i ) For squamous cell carcinoma: Stage 1A 2 or 1B 1 with a shallow depth of 2 cm or less ii ) For adenocarcinoma: Stage 1A 2 or 1B with a lateral diameter of 1 cm or less 3 ) Radical trachelectomy i ) For squamous cell carcinoma: Stage 1B 1 ( including slight vaginal invasion of early 2A 1 ) ii ) For adenocarcinoma ( including adenosquamous carcinoma ): cases with stage 1B 1 up to 3 cm 3. As for the depth of the cervical lesion, in cases where there is a margin of 1 cm or more in squamous cell carcinoma and 2 cm or more in adenocarcinoma from the cervix to the margin of the lesion in MRI, 4. Women over 20 years old and under 45 years old 5. There is a strong hope for infertility treatment 6. There was no lymph node metastasis by intraoperative rapid pathological examination, and uterine side stump was negative by 5 mm or more.
Exclusion criteria
Exclusion criteria: 1. Active duplicate cancer 2. Infertility factor of patients or partners which is extremely difficult to treat 3. Special histological type ( small cell carcinoma, MDA etc ) 4. Lymph node metastasis or extrauterine invasion is suspected 5. Metastasis to the adnexa or other abdominal cavity intraoperatively 6. Serious complications 7. Psychosis or psychiatric symptoms were judged to be difficult to participate in the study 8. Glaucoma 9. Untreated cerebral aneurysms 10. Other cases inappropriate judged by medical doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients who were able to complete trachelectomy by robotic surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Evaluation of safety ( operation time, intraoperative bleeding volume, intraoperative / postoperative complication ) 2. Hospitalization period, postoperative QOL evaluation 3. Evaluation of diagnostic accuracy for preoperative lesion spread ( lymph node metastasis, extrauterine progressive lesion, distance between stump and lesion, depth of infiltration, etc. ) 4. Change rate to hysterectomy, laparotomy transition, postoperative additional treatment 5. Evaluation of treatment prognosis ( recurrence rate ) 6. Pregnancy rate ( example of wish for infant ) 7. Evaluation of complications during pregnancy and delivery ( current premature production rate, pregnant weeks of delivery, incidence of delayed fetal growth retardation, incidence of other complications ) 8. Evaluation of production rate, birth rate | — |
Contacts
Public ContactShinichi TOGAMI
Kagoshima University Hospital
Outcome results
None listed