ArticleSurgical endoscopy2015
Laparoscopic cholecystectomy using a novel single-incision surgical platform through a standard 15 mm trocar: initial experience and technical details.
Article in Surgical endoscopy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 2 of them syntheses that pooled it.
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Who cites it
9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 19 citations in OpenAlex.
- Laparoscopic surgery and robotic surgery for single-incision cholecystectomy: an updated systematic review.Updates in surgery · 2021Pooled it
- [New techniques and training methods for robot-assisted surgery and cost-benefit analysis of Ivor Lewis esophagectomy].Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen · 2021Pooled it
- Phase II clinical experience and long-term follow-up using the next-generation single-incision platform FMX314.Surgical endoscopy · 2016Trial
- Motion Measurement and Analysis of Different Instruments for Single-Incision Laparoscopic Surgery.Applied bionics and biomechanics · 2022Article
- Learning curve of surgical novices using the single-port platform SymphonX: minimizing OR trauma to only one 15-mm incision.Surgical endoscopy · 2021Article
- True single-port cholecystectomy with ICG cholangiography through a single 15-mm trocar using the new surgical platform "symphonX": first human case study with a commercially available device.Surgical endoscopy · 2020Article
- Task performance in standard laparoscopy in comparison with single-incision laparoscopy in a modified skills trainer.Surgical endoscopy · 2016Article
- Do height and weight affect the feasibility of single-incision laparoscopic cholecystectomy?Surgical endoscopy · 2015Article
- A new glove port for single incision procedure.Annals of surgical treatment and research · 2015Article
Corrections and comments
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Authors and funding
11 authors at 4 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveSingle-incision minimally invasive surgery has previously been associated with incisions 2.0-3.0 cm in length. We present a novel single-incision surgical platform compatible for insertion through a standard 15-mm trocar. The objective of this study is to evaluate the safety and feasibility of the platform.
methodsThe technology is currently a Phase I investigational device. It features articulating surgical instruments and is inserted through a multiple-use introducer. The platform's introducer requires a standard 15-mm laparoscopic trocar. Cholecystectomy is performed through a 15-mm umbilical incision utilizing an additional epigastric 2-mm needle-port grasper for gallbladder retraction. A prospective feasibility study was performed at a single-center. Inclusion criteria were age 18-75 years and biliary colic. Patients were excluded if they had acute cholecystitis, dilation of the biliary tree, severe coagulopathy, BMI > 40 kg/m(2), or choledocholithiasis. Endpoints included the success rate of the platform, hospital length of stay, post-operative pain medication usage, cosmetic results, and presence of hernia.
resultsSix patients (5 female) with an average age of 41 years and BMI 28 kg/m(2) underwent cholecystectomy with the platform. Average OR time was 91 min and umbilical incision length did not exceed 15 mm. One case was converted to standard laparoscopy due to mechanical failure of the clip applier instrument. There were no intraoperative complications. Post-operatively, two patients developed self-resolving umbilical ecchymoses. Average length of stay was 13 h. Pain control was achieved with diclofenac for less than 7 days. At 1 month follow-up there were no complications and no umbilical hernias.
conclusionsThis phase I study demonstrates that single-incision cholecystectomy through a 15-mm trocar with the Fortimedix Surgical B.V. single-incision surgical platform is feasible, safe, and reproducible. Additional benefits include excellent triangulation and range of motion as well as exceptional cosmetic results. Further studies will be needed to evaluate long-term hernia rates.
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