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A non-randomized confirmatory trial of minimum invasive laparoscopic radical hysterectomy (new-Japanese LRH) for patients with early-stage cervical cancer

A non-randomized confirmatory trial of minimum invasive laparoscopic radical hysterectomy (new-Japanese LRH) for patients with early-stage cervical cancer - A non-randomized confirmatory trial of minimum invasive laparoscopic radical hysterectomy (new-Japanese LRH) for patients with early-stage cervical cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000045224
Enrollment
440
Registered
2021-10-01
Start date
2021-09-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cervical cancer

Interventions

minimum invasive laparoscopic radical hysterectomy (new-Japanese LRH)

Sponsors

Kobe university
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1.Histopathologically, the primary lesion is confirmed to be cervical cancer 2.The histological type of cervical cancer is one of the following /Squamous cell carcinoma (Squamous cell carcinoma, keratinizing type, Squamous cell carcinoma, non-keratinizing type) /Adenocarcinoma (Endocervical adenocarcinoma, usual type, Mucinous carcinoma, intestinal type, Endometrioid carcinoma) /Adenosquamous carcinoma (Excluding Glassy cell carcinoma). 3.The clinical stage classification of cervical cancer (JSOG 2020, FIGO 2018) is diagnosed as stage 1A2, 1B1/2, or 2A1.

Exclusion criteria

Exclusion criteria: 1.Tumor diameter of cervical cancer exceeding 4cm(Patients will not be eligible for this study if the tumor diameter exceeds 4 cm in any one of the following: measurement by MRI, direct measurement by colposcopy, or measurement by conization specimen) 2.Active multiple cancers (concurrent multiple cancers and heterogeneous multiple cancers with disease-free interval of 5 years or less). However, carcinoma in situ (intraepithelial carcinoma) and intramucosal carcinoma equivalent lesions that are considered curable by local treatment are not included in active multiple cancers). 3.History of radiotherapy treatment to the abdomen or pelvis. 4.Active infection. 5.Fever of 38 degree or higher at the time of registration. 6.Pregnant or breastfeeding. 7.Psychiatric illness/symptoms that would limit compliance the study requirement. 8.Receiving continuous systemic administration of steroids (oral or intravenous). 9.Uncontrolled diabetes mellitus or diabetes mellitus by continuous insulin use. 10.Uncontrolled hypertension

Design outcomes

Primary

MeasureTime frame
4.5-year recurrence-free survival

Countries

Japan

Contacts

Public ContactNobutaka Takahashi

shizuoka cancer center gynecology

n.takahashi@scchr.jp055-989-5222

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026