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Laparoscopic Treatment of Cervical Carcinoma: a Randomized Controlled Trial.

A phase II Randomized Clinical Trial of Laparoscopic Radical Hysterectomy Without Lifting the Uterus Versus Abdominal Radical Hysterectomy in Patients With Early Stage Cervical Cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030160
Enrollment
Unknown
Registered
2020-02-24
Start date
2020-03-01
Completion date
Unknown
Last updated
2020-02-25

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

Conditions

Cervical Carcinoma

Interventions

control group:Abdominal radical hysterectomy and pelvic lymph node dissection, with or without abdominal aortic lymph node resection
experimental group:Laparoscopic radical hysterectomy and pelvic lymph node dissection, with or without abdominal aortic lymph node resection

Sponsors

Cancer Hospital of University of Chinese Academy of Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years; 2. FIGO(2018) stage is IA1 (with blood vessel invasion), IA2 and IB1; 3. the maximum diameter of the tumor 3.0x10^9cells/L; (2) Platelet count > 100x10^9/L; (3) Creatinine < 180 umol/L; (4) Bilirubin < 1.5 times normal, and AST/ALT< 3 times normal; 9. ECOG score 0-1; 10. patients with surgical indications; 11. patients who have signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. the imaging assessment showed that the cervical tumor invaded the outer third of the interstitial layer, or involved the lower part of the uterus. 2. serum levels of AFP, HCG were elevated, or CEA, CA199 and CA125 were more than 5 times higher than normal. 3. pregnant women; 4. patients with surgical contraindications; 5. patients with metastatic lesions, pelvic/abdominal para-aortic lymph node enlargement (> 2cm, or minor axis > 1cm, or patients with positive lymph nodes; 6. patients who accompanied by serious systemic diseases inconsistent with the study (at the discretion of the investigator); 7. patients who cannot tolerate bladder lithotomy or trendelenburg position; 8. patients whose medical compliance and geographical location cannot guarantee adequate follow-up; 9. patients with a history of pelvic or peritoneal radiotherapy.

Design outcomes

Primary

MeasureTime frame
disease free survival;

Secondary

MeasureTime frame
recurrence pattern and site of the two groups;Incidence of treatment-related complications within 6 months after surgery of the two groups;economic cost-effectiveness of both groups;quality of life for both groups;pelvic floor function in both groups;overall survival;

Countries

China

Contacts

Public ContactTao Zhu

Cancer Hospital of University of Chinese Academy of Sciences

zhutao@zjcc.org.cn+86 13858065156

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 11, 2026