Clinical trial · Interventional
A Multicentre Trial of Nerve-Spring Radical Hysterectomy vs. Radical Hysterectomy for Cervical Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators designed this multicentre randomized study to investigate the clinical benefits of nerve-spring radical hysterectomy for cervical cancer. Patients with FIGO stage Ia2, Ib1, IIa1 and FIGO stage Ib2, IIa2 after neoadjuvant chemotherapy are randomized to either nerve-spring radical hysterectomy or radical hysterectomy. The primary endpoint are urodynamic outcome including maximum flow rate, residual volume, maximum vesical compliace, cystomctric capacity at first desire, and maximum cystomctric capacity. A total 240 patients (120 per treatment arm) are planned to accrue for this study within 7 years.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nerve-spring radical hysterectomy | Procedure | — | UNRESOLVED |
| radical hysterectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- NSRH
- description
- patients in Arm NSRH undergo nerve-spring radical hysterectomy (NSRH)
- interventionNames
- Procedure: Nerve-spring radical hysterectomy
- type
- ACTIVE_COMPARATOR
- label
- RH
- description
- patients in Arm RH undergo radical hysterectomy (RH)
- interventionNames
- Procedure: radical hysterectomy
Primary outcomes (5)
- measure
- maximum flow rate measured by Urodynamic at 6 months postoperative
- timeFrame
- on 6 months postoperative
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 17 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. FIGO(2009) stage Ia2, Ib1, and IIa1 Untreated cervical cancer OR FIGO(2009) stage Ib2 and IIa2 cervical cancer that possible to surgery after neoadjuvant chemotherapy 2. Possible to radical hysterectomy or nerve-spring radical hysterectomy 3. Age: 17 to 60 years 4. No complication during operation 5. Written informed consent Exclusion Criteria: 1. patients who underwent radiotherapy 2. Pathologically diagnosed Pathologically diagnosed squamous carcinoma, Small Cell Carcinoma, Small Cell Carcinoma 3. Patients who have uncontrolled diabetes or uncontrolled hypertension 4. patients with neurogenic bladder dysfunction 5. patients with uterine prolapse 6. Patients with psychiatric illness 7. Patients who have active infection 8. Patients who have had heart failure, unstable angina, or myocardial infarction within the past 6 months 9. Patients who are unable to undergo radical hysterectomy for complication of excessive obesity, liver cirrhosis, or bleeding tendency
References
Publications (0)
Data not yet available