New study challenges safety of keyhole surgery for cervical cancer
NCT ID NCT03955185
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two surgical methods for early-stage cervical cancer: minimally invasive (keyhole or robot-assisted) surgery and traditional open abdominal surgery. Researchers will follow 2000 patients for up to 5 years to see which approach leads to better survival and fewer cancer recurrences. The goal is to provide clear evidence on the best surgical option for patients.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 2,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2019
- Expected to finish
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May 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients with FIGO stage (2018) IA1 (with lymph vascular space invasion), IA2, IB1, IB2 or IIA1 disease * Preoperative histologically confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix * Age ≤ 65 years old; * Physical grading: Karnofsky score ≥ 60 points; * Initial treatment; * Voluntarily joined the study, signed informed consent, willing to comply, and cooperative with follow-up; (Note: The maximum diameter of the cervical lesion is subject to MRI measurements) Exclusion Criteria for Preoperative Patients: * Patients with contraindications to surgery; * Patients who have previously received pelvic/abdominal radiation or chemotherapy;Patients who had received radiotherapy and chemotherapy for other cancers in the past. * Patients with evidence of extra cervical metastases by CT, MRI or PET. * Unable or unwilling to sign informed consent. * Unable or unwilling to comply with research requirements. * Patients with diameter of lymph node metastasis ≥ 2 cm by preoperative MRI. * Patients with pregnancy. * Patients requiring fertility-preserving surgery. * Patients who had previously received subtotal hysterectomy. * Patients participating in other clinical trials. * Patients with other reasons not suitable clinical trials identified by researchers. Exclusion Criteria for Postoperative Patients: * Postoperative pathology: endometrioid adenocarcinoma, clear cell carcinoma, special type adenocarcinoma, neuroendocrine carcinoma (small cell carcinoma), tuberculosis. * Postoperative tumor size ≥ 4 cm. * Patients with abdominal aortic lymph node metastasis. * Patients with severe postoperative complications that are not suitable for adjuvant therapy and affect patient follow-up. * Patients who did not follow requirements for various reasons (except for various complications and deaths caused by tumor recurrence and metastasis). * Situation which researchers believe that treatment should be terminated.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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