Clinical trial · Interventional
The Comparison of Conventional and Advanced Bipolar Energy Modalities During Laparoscopic Staging Surgery of Gynecologic Cancers
The Impact of Bipolar Energy Modalities on Peri-operative Outcome During Laparoscopic Staging Surgery of Gynecologic Cancers: A Randomized Clinical Trial
- 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)
This single-institution prospective randomized clinical trial will be performed at the Gynecologic Oncology clinic of Ankara University. Patients with endometrial cancer and cervix cancer who will be operated for staging via laparoscopic approach will be included in the study. The included patients will be randomized to two groups before surgery. During the operation of first group instruments with advanced bipolar energy will be used during lymphadenectomy and hysterectomy and salpingo-oophorectomy. In the second group the operation will be performed by conventional bipolar energy forceps. The outcome parameters to be measured are intra-operative bleeding, duration of operation, intraoperative complications, postoperative pain score, postoperative complications, postoperative duration of hospitalization, late complications such as lymphocele formation and costs.
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 |
|---|---|---|---|
| Perioperative Period | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ligasure-Covidien | Device | — | UNRESOLVED |
| RoBi forceps-Karl Storz | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Advanced bipolar (Ligasure-Covidien)
- description
- Devices with advanced bipolar energy (Ligasure-Covidien) will be used during laparoscopic hysterectomy and pelvic lymphadenectomy
- interventionNames
- Device: Ligasure-Covidien
- type
- ACTIVE_COMPARATOR
- label
- Conventional bipolar (RoBi forceps-Karl Storz)
- description
- Devices with conventional bipolar energy (RoBi rotating bipolar forceps-Karl Storz) will be used during laparoscopic hysterectomy and pelvic lymphadenectomy
- interventionNames
- Device: RoBi forceps-Karl Storz
Primary outcomes (2)
- measure
- Duration of operation
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologic diagnosis of endometrial or cervix cancer * Stage I, IB1, IIA1 cervix cancer or patients with partial or complete response to chemoradiotherapy * Clinically stage I and II endometrial cancer Exclusion Criteria: * Hematologic abnormality * Coagulation disorder * Present or past thromboembolic disease * ECOG performance \>2 * Advanced stage disease * Fertility preserving surgery
References
Publications (1)
- DERIVEDTaskin S, Sukur YE, Altin D, Turgay B, Varli B, Baytas V, Ortac F. Bipolar Energy Instruments in Laparoscopic Uterine Cancer Surgery: A Randomized Study. J Laparoendosc Adv Surg Tech A. 2018 Jun;28(6):645-649. doi: 10.1089/lap.2017.0639. Epub 2018 Jan 11. PMID 29323616