Trial reportSurgical endoscopy2013
A prospective, randomized clinical comparison between UltraCision and the novel sealing and cutting device BiCision in patients with laparoscopic supracervical hysterectomy.
Trial report in Surgical endoscopy, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01806012 (Use of the Enseal Intrument for Laparoscopic Supracervical Hysterectomy), which is not on this map. Cited by 6 papers, 4 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Use of the Enseal Intrument for Laparoscopic Supracervical Hysterectomy: a Randomized, Single-Blinded Study Comparing the Efficacy to the Routine Procedure
Who cites it
6 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Applications of different energy devices in laparoscopic and robotic gynecological surgery: a systematic review.Archives of gynecology and obstetrics · 2025Pooled it
- Advanced bipolar vessel sealing devices vs conventional bipolar energy in minimally invasive hysterectomy: a systematic review and meta-analysis.Archives of gynecology and obstetrics · 2024Pooled it
- An umbrella review of the surgical performance of Harmonic ultrasonic devices and impact on patient outcomes.BMC surgery · 2023Pooled it
- Electrosurgical Devices Used During Laparoscopic Hysterectomy.JSLS : Journal of the Society of Laparoendoscopic SurgeonsPooled it
- An ergonomic field study to evaluate the effects of a rotatable handle piece on muscular stress and fatigue as well as subjective ratings of usability, wrist posture and precision during laparoscopic surgery: an explorative pilot study.International archives of occupational and environmental health · 2018Article
- Evaluation of the HystSim™-virtual reality trainer: an essential additional tool to train hysteroscopic skills outside the operation theater.Surgical endoscopy · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundVarious surgical procedures for hysterectomy exist; with laparoscopic supracervical hysterectomy (LASH) becoming an established option in recent years. Therefore, energy-based technologies for rapid tissue sealing and cutting are in the focus of surgeons. The aim of this trial was to prove or disprove investigated noninferiority of the novel device BiCision in comparison to the widely used UltraCision in a routine procedure ( www.clinicaltrials.gov ; study identifier NCT01806012).
methodsThirty LASH procedures were performed with UltraCision and BiCision after randomization of the preparation sides. The primary end point was the resection time per side and instrument. The instruments were also compared concerning blood loss and coagulation and cutting qualities as well as postoperative complications. The patients were followed for 3 months.
resultsMean preparation time per side was 8.8 ± 1.8 min for BiCision and 8.3 ± 1.9 min for UltraCision (p = 0.31), which was not significantly different. Both instruments achieved complete transection without the need of additional cutting attempts. BiCision was significantly superior regarding the number of coagulations for complete hemostasis before and after the removal of the uterine corpus (before: 6.9 ± 4.8 for BiCision and 8.6 ± 4.1 for UltraCision, p = 0.047; after: 5.4 ± 1.2 for BiCision and 8.6 ± 3.2 for UltraCision, p < 0.0001) and intraoperative blood loss (score 1.07 ± 0.25 for BiCision vs. 1.63 ± 0.49 for UltraCision, p < 0.0001). Tissue sticking to the instrument occurred less often on the BiCision side (score 0.14 ± 0.35 for BiCision vs. 0.60 ± 0.81 for UltraCision, p = 0.015). BiCision showed a significantly better fixation of the tissue (grip score 0.23 ± 0.43 for BiCision vs. 1.00 ± 0.74 for UltraCision, p < 0.0001). No intraoperative or postoperative complications were seen for both instruments.
conclusionsThe efficacy and quality of vessel sealing and cutting with BiCision is not inferior to the UltraCision device. Resection time was comparable, and complete hemostasis could be achieved faster in a clinical setting. Therefore, BiCision is at least as reliable as UltraCision for laparoscopic indications.
Indexed as
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.