Clinical trial · Interventional
Laparoscopic vs Abdominal Radical Hysterectomy In Patients With Early Cervical Cancer
Laparoscopic vs Abdominal Radical Hysterectomy With Pelvic Lymphadenectomy in Patients With Early Cervical Cancer: A Randomized Clinical Trial
NCT01258413CI-TRIAL-00004224completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of this study is to determine whether laparoscopic radical hysterectomy for early cervical cancer will has decreased postoperative pain intensity compared to abdominal radical hysterectomy with similar postoperative complications and survival rates.
Conditions
Conditions (2)
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 |
| Postoperative Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abdominal radical hysterectomy | Procedure | — | UNRESOLVED |
| Laparoscopic Radical Hysterectomy + pelvic lymphadenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Laparoscopic Radical Hysterectomy
- description
- uterus, upper 1-2cm of vagina , parametrial tissue and uterosacral ligament are removed + pelvic lymphadenectomy
- interventionNames
- Procedure: Laparoscopic Radical Hysterectomy + pelvic lymphadenectomy
- type
- ACTIVE_COMPARATOR
- label
- Abdominal radical hysterectomy
- description
- uterus, upper 1-2cm of vagina , parametrial tissue and uterosacral ligament are removed + pelvic lymphadenectomy
- interventionNames
- Procedure: Abdominal radical hysterectomy
Primary outcomes (1)
- measure
- postoperative pain measured by a 10 point numeric rating scale
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women of 18 years or older referred to our service with histologically confirmed primary squamous, adenocarcinoma or adenosquamous cervical cancer diagnosed by biopsy or cervical conization, clinically FIGO (International Federation of Gynecologic and Obstetrics) staged IA2 with lymph vascular invasion, IB and II A. Exclusion Criteria: * Patients with clinically advanced disease (IIB-IV), previous pelvic or abdominal radiotherapy, pregnancy, clinical diseases that would preclude one or both surgical approaches.
References
Publications (1)
- DERIVEDCampos LS, Limberger LF, Stein AT, Kalil AN. Postoperative pain and perioperative outcomes after laparoscopic radical hysterectomy and abdominal radical hysterectomy in patients with early cervical cancer: a randomised controlled trial. Trials. 2013 Sep 12;14:293. doi: 10.1186/1745-6215-14-293. PMID 24028441