Establishment of suitable surgical methods for Japanese women in robot assisted radical trachelectomy for patients with cervical cancer who wish to preserve fertility.

Phase 2

Recruiting

• Conditions: cervical cancer; trachelectomy

• Registration Number: JPRN-jRCTs072180078
• Lead Sponsor: KOBAYASHI Hiroaki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 15

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified