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A Prospective Cohort Study on Comparison of Long-term Toxicity and Efficacy of Postoperative Adjuvant Radiotherapy Between Transvaginal Laparoscopy and Transabdominal Laparoscopy for Early-stage Cervical Cancer

A Prospective Cohort Study on Comparison of Long-term Toxicity and Efficacy of Postoperative Adjuvant Radiotherapy Between Transvaginal Laparoscopy and Transabdominal Laparoscopy for Early-stage Cervical Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600123694
Enrollment
Unknown
Registered
2026-04-29
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

cervical cancer

Interventions

transvaginal laparoscopic surgery, vNOTES:None
transabdominal laparoscopic surgery, LPS:None

Sponsors

Chengdu Women's and Children's Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Female patients aged 18 to 75 years; 2.Meeting the aforementioned pathological diagnosis and clinical staging criteria of FIGO 2018 Stage ?A1–?A2; 3.Undergoing radical hysterectomy plus pelvic lymphadenectomy / sentinel lymph node dissection via either vNOTES or LPS approach, with strict adherence to the modified tumor-free technique during surgery; 4.Postoperative pathology confirming high-risk or intermediate-risk factors indicating the need for postoperative adjuvant radiotherapy; 5.ECOG performance status score of 0–1; 6.Laboratory examinations including hepatic and renal function, routine blood test, and coagulation function meeting the criteria for radiotherapy and chemotherapy, with no contraindications to radiotherapy and chemotherapy; 7.Being able to cooperate in completing multimodal imaging examinations and follow-up for up to 5 years; 8.Voluntarily signing the informed consent form, understanding the study content and agreeing to cooperate.

Exclusion criteria

Exclusion criteria: 1.Complicated with other malignant tumors, or with a history of previous pelvic radiotherapy; 2.Undergoing open surgery rather than vNOTES or LPS approach; 3.Presence of severe pelvic adhesions, pelvic infection, intestinal obstruction, or other contraindications to radiotherapy; 4.ECOG score = 2, unable to tolerate surgery or postoperative chemoradiotherapy; 5.Abnormal results of hepatic and renal function, routine blood test, or other indicators that do not meet the requirements for chemoradiotherapy; 6.Pregnant or lactating females; 7.Suffering from mental illness, cognitive impairment, etc., unable to cooperate with examinations and follow-up; 8.Refusing to sign the informed consent form or declining to participate in study follow-up.

Design outcomes

Primary

MeasureTime frame
Incidence rate of grade =2 late toxicities at 3 years;

Secondary

MeasureTime frame
Overall Survival, OS;Disease-Free Survival, DFS;Acute toxicity incidence;Quality of life (QoL) score;

Countries

China

Contacts

Public ContactYonghong Lin

Chengdu Women's and Children's Central Hospital

linyhcd2011@163.com+86 138 0803 1895

Outcome results

None listed

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