Universität zu Köln

Berducci, Martin, Fuchs, Hans F., Omelanczuk, Pablo, Broderick, Ryan C., Harnsberger, Cristina R., Langert, Joshua, Nefa, Jorge, Jaureguiberry, Pablo, Gomez, Pablo, Miranda, Laura, Jacobsen, Garth R., Sandler, Bryan J. and Horgan, Santiago (2016). Phase II clinical experience and long-term follow-up using the next-generation single-incision platform FMX314. Surg. Endosc., 30 (3). S. 953 - 961. NEW YORK: SPRINGER. ISSN 1432-2218

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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/m(2), 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/m(2) 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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Berducci, Martin UNSPECIFIED UNSPECIFIED UNSPECIFIED Fuchs, Hans F. UNSPECIFIED UNSPECIFIED UNSPECIFIED Omelanczuk, Pablo UNSPECIFIED UNSPECIFIED UNSPECIFIED Broderick, Ryan C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Harnsberger, Cristina R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Langert, Joshua UNSPECIFIED UNSPECIFIED UNSPECIFIED Nefa, Jorge UNSPECIFIED UNSPECIFIED UNSPECIFIED Jaureguiberry, Pablo UNSPECIFIED UNSPECIFIED UNSPECIFIED Gomez, Pablo UNSPECIFIED UNSPECIFIED UNSPECIFIED Miranda, Laura UNSPECIFIED UNSPECIFIED UNSPECIFIED Jacobsen, Garth R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Sandler, Bryan J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Horgan, Santiago UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-282732
DOI:	10.1007/s00464-015-4319-2
Journal or Publication Title:	Surg. Endosc.
Volume:	30
Number:	3
Page Range:	S. 953 - 961
Date:	2016
Publisher:	SPRINGER
Place of Publication:	NEW YORK
ISSN:	1432-2218
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language CONVENTIONAL LAPAROSCOPIC CHOLECYSTECTOMY; INITIAL-EXPERIENCE; TECHNICAL DETAILS; SURGERY; COHORT; PAIN; 2MM Multiple languages Surgery Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/28273