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A randomized controlled comparison study of modified C1 operation and conventional C2 operation in early-stage cervical cancer with radical hysterectomy

A randomized controlled comparison study of modified C1 operation and conventional C2 operation in early-stage cervical cancer with radical hysterectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061671
Enrollment
Unknown
Registered
2022-06-30
Start date
2022-06-30
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

Cervical Cancer

Interventions

experimental group:receive modified C1 hysterectomy
control group:receive conventional C2 hysterectomy

Sponsors

National Cancer Center/ National Clinical Research Center for Cancer/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Pathologically diagnosed as cervical squamous call carcinoma, adenocarcinoma, or adenosquamous carcinoma; 2. Aged 18 - 70 years; 3. Stage IB1, IB2, IIA1 (FIGO 2018); 4. No evidence of distant metastasis in whole body imaging (chest, abdominal, pelvic CT; PET-CT); 5. ECOG <= 2 and able to tolerate hysterectomy and pelvic lymphadenectomy; 6. No serious cardiac, hepatic, renal chronic diseases or dysfunction, or history of other malignant tumors; 7. Volunteer to participate in this study and have signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Pathologically diagnosed as cervical small cell carcinoma, neuroendocrine carcinoma, or other special types of carcinoma; 2. Preoperative evaluation suggests that the tumor is closely related to pelvic autonomic nerves and unable to reserve nerves; 3. Preoperative urination, defecation, or sexual dysfunction; 4. Accepted radiotherapy or chemotherapy before participating in this study; 5. Serious complications that affect operations.

Design outcomes

Primary

MeasureTime frame
Recovery rate of spontaneous;2-year disease-free survival rates;

Secondary

MeasureTime frame
Duration of operation;Intraoperative bleeding volume;Blood transfusion ratio;Operative complications;Hospitalization time;Bladder function;Rectal function;Sex function;

Countries

China

Contacts

Public ContactDan Zhao

National Cancer Center/ National Clinical Research Center for Cancer/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

cicams@163.com+86 13718815656

Outcome results

None listed

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