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A clinical trial to evaluate the efficacy and safety of laparoscopic radical hysterectomy and pelvic lymphadenectomy assisted by laparoscopic surgery

A clinical trial to evaluate the efficacy and safety of laparoscopic radical hysterectomy and pelvic lymphadenectomy assisted by laparoscopic surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082083
Enrollment
Unknown
Registered
2024-03-20
Start date
2024-03-20
Completion date
Unknown
Last updated
2024-03-25

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

Conditions

Radical hysterectomy + pelvic lymphadenectomy for cervical cancer

Interventions

Sponsors

The First Affiliated Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Patients diagnosed with cervical cancer, and the clinical stage (FIGO stage) is stage IA to IIA (inclusive); (2) Patients who were determined by the investigator to need radical hysterectomy (radical hysterectomy + pelvic lymphadenectomy) for cervical cancer; (3) Aged 18-75 (inclusive); (4) Be able to cooperate and complete follow-up and related examinations; (5) Voluntarily participate in this trial and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Preoperative imaging revealed positive pelvic or para-aortic lymph nodes; (2) Those who have received preoperative radiotherapy and/ or immunotherapy and/ or targeted therapy; (3) Those who cannot tolerate anesthesia and surgery; (4) Persons with reproductive needs; (5) Pregnant or lactating women; (6) Participating in other clinical trials of investigational drugs or devices that have not been completed; (7) Patients who are considered by the investigator to be unsuitable for participation in this program.

Design outcomes

Primary

MeasureTime frame
Rate of unconverted surgery;The incidence of device related or potentially related complications;

Secondary

MeasureTime frame
Operation time;Intraoperative bleeding;Intraoperative transfusion rate;Postoperative pain score;Postoperative 24-hour drainage volume;Number of lymph node resections;Equipment defect incidence rate;Postoperative hospitalization time;Overall incidence of surgical complications;Incidence rate of adverse events and serious adverse events;

Countries

China

Contacts

Public ContactTang Junying

The First Affiliated Hospital of Chongqing Medical University

tangjy_cqmu@sina.com+86 135 0835 1600

Outcome results

None listed

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