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Published in:

01-03-2016

Phase II clinical experience and long-term follow-up using the next-generation single-incision platform FMX314

Authors: Martin Berducci, Hans F. Fuchs, Pablo Omelanczuk, Ryan C. Broderick, Cristina R. Harnsberger, Joshua Langert, Jorge Nefa, Pablo Jaureguiberry, Pablo Gomez, Laura Miranda, Garth R. Jacobsen, Bryan J. Sandler, Santiago Horgan

Published in: Surgical Endoscopy | Issue 3/2016

Abstract

Background

Single-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 we previously described in six patients with short-term follow-up data. The objective of this phase II study was to evaluate the safety and feasibility of the platform in a larger collective and to evaluate 1-year follow-up data of the phase I trial.

Methods

The technology features a multiple-use introducer, accommodating the articulating instruments, and is inserted through a 15-mm laparoscopic trocar. Cholecystectomy is performed through an umbilical incision. A prospective feasibility study was performed at a single center. Inclusion criteria were age of 18–75 years and biliary colic, exclusion criteria were acute cholecystitis, dilation of the biliary tree, severe coagulopathy, BMI > 40 kg/m², or choledocholithiasis. Endpoints included complications, length of stay, pain medication, cosmetic results, and the presence of hernia.

Results

Twenty-seven patients (23 females; phase I: 6 patients, phase II: 21 patients) with an average age of 41.7 years and BMI 26.6 kg/m² were recruited for the study. Umbilical incision length did not exceed 15 mm. There were no intraoperative complications. Average OR time decreased from 91 min for the first six cases to 56 min for the last six cases. Average length of stay was 7.8 h. Pain control was achieved with diclofenac for no more than 7 days. All patients had no adverse events at 5-month follow-up, and all phase I patients had no adverse events nor evidence of umbilical hernia at 1 year.

Conclusion

This study demonstrates that single-incision cholecystectomy with the platform is feasible, safe, and reproducible in a larger patient population. Long-term follow-up showed no hernias or other adverse events. Further studies will be needed to evaluate longer-term hernia rates.

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Title: Phase II clinical experience and long-term follow-up using the next-generation single-incision platform FMX314
Authors: Martin Berducci
Hans F. Fuchs
Pablo Omelanczuk
Ryan C. Broderick
Cristina R. Harnsberger
Joshua Langert
Jorge Nefa
Pablo Jaureguiberry
Pablo Gomez
Laura Miranda
Garth R. Jacobsen
Bryan J. Sandler
Santiago Horgan
Publication date: 01-03-2016
Publisher: Springer US
Published in: Surgical Endoscopy / Issue 3/2016
Print ISSN: 0930-2794
Electronic ISSN: 1432-2218
DOI: https://doi.org/10.1007/s00464-015-4319-2

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Phase II clinical experience and long-term follow-up using the next-generation single-incision platform FMX314

Abstract

Background

Methods

Results

Conclusion

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods

Results

Conclusion

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