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Laparoscopic Versus Abdominal Radical Hysterectomy for Cervical Cancer: Rationale, Design and Implementation of a Randomized Trial From China

Laparoscopic Versus Abdominal Radical Hysterectomy for Cervical Cancer: Rationale, Design and Implementation of a Randomized Trial From China

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900025946
Enrollment
Unknown
Registered
2019-09-15
Start date
2019-09-01
Completion date
Unknown
Last updated
2019-09-16

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

Conditions

Cervical Cancer

Interventions

ARH group:Abdominal Radical Hysterectomy
LRH group:Laparoscopic Radical Hysterectomy

Sponsors

Obstetrics and Gynecology Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
21 Years to 65 Years

Inclusion criteria

Inclusion criteria: Participants meeting all of the following criteria will be considered for enrollment: 1. Clinical diagnosis of early cervical cancer (IA1 includes invasion of lymphatic vascular, IA2, IB1, IB2, IB3, IIA1, IIA2); 2. Histologically confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of uterine cervix; 3. Aged from 21 to 65 years; 4. With normal renal and hepatic function; 5. Patient's ability to endure surgery; 6. First time receiving treatment for cervical cancer; 7. Subjects volunteered to participate in this study and signed informed consent, with good compliance and follow-up.(note: the maximum diameter of cervical lesions is measured by CT and MRI).

Exclusion criteria

Exclusion criteria: Participants meeting one of the following criteria will be excluded from enrollment into this study: 1. Operation taboos cannot be accepted; 2. CT, MRI or PET indicated cervical metastasis; 3. With a history of malignant tumor.

Design outcomes

Primary

MeasureTime frame
DFS and OS for the third and the fifth year;

Secondary

MeasureTime frame
Intraoperative and postoperative complications;

Countries

China

Contacts

Public ContactXin Wu

Obstetrics and Gynecology Hospital, Fudan University

sky_xin1980@aliyun.com+86 021-33189900-6529

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026