JPRN-jRCTs072180078招募中2 期
Establishment of suitable surgical methods for Japanese women in robot assisted radical trachelectomy for patients with cervical cancer who wish to preserve fertility. - Establishment of suitable surgical methods for Japanese women in robot assisted radical trachelectomy for patients with cervical cancer who wish to preserve fertility.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 45age old（—）
- 性别
- Female
入选标准
- •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.
排除标准
- •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
研究者
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