Single-Incision Multiport/Single Port Laparoscopic Abdominal Surgery (SILAP): A Prospective Multicenter Observational Quality Study.
BACKGROUND
Increasing experience with minimally invasive surgery and the development of new instruments has resulted in a tendency toward reducing the number of abdominal skin incisions. Retrospective and randomized prospective studies could show the feasibility of single-incision surgery without any increased risk to the patient. However, large prospective multicenter observational datasets do not currently exist.


OBJECTIVE
This prospective multicenter observational quality study will provide a relevant dataset reflecting the feasibility and safety of single-incision surgery. This study focuses on external validity, clinical relevance, and the patients' perspective. Accordingly, the single-incision multiport/single port laparoscopic abdominal surgery (SILAP) study will supplement the existing evidence, which does not currently allow evidence-based surgical decision making.


METHODS
The SILAP study is an international prospective multicenter observational quality study. Mortality, morbidity, complications during surgery, complications postoperatively, patient characteristics, and technical aspects will be monitored. We expect more than 100 surgical centers to participate with 5000 patients with abdominal single-incision surgery during the study period.


RESULTS
Funding was obtained in 2012. Enrollment began on January 01, 2013, and will be completed on December 31, 2018. As of January 2016, 2119 patients have been included, 106 German centers are registered, and 27 centers are very active (>5 patients per year).


CONCLUSIONS
This prospective multicenter observational quality study will provide a relevant dataset reflecting the feasibility and safety of single-incision surgery. An international enlargement and recruitment of centers outside of Germany is meaningful.


BACKGROUND
German Clinical Trials Register: DRKS00004594; https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00004594 (Archived by WebCite at http://www.webcitation.org/6jK6ZVyUs).
Brandenburg Medical School, Department of Surgery, University Hospital Brandenburg / Havel, Brandenburg, Germany. mantke.mhb@klinikum-brandenburg.de.
Rene
http://orcid.org/0000-0001-5590-6019
R
Mantke
Markus
http://orcid.org/0000-0003-0319-3090
M
Diener
Siegfried
http://orcid.org/0000-0002-5197-3481
S
Kropf
Ronny
http://orcid.org/0000-0002-5914-1129
R
Otto
Thomas
http://orcid.org/0000-0001-7979-324X
T
Manger
Boris
http://orcid.org/0000-0003-1801-1376
B
Vestweber
Lutz
http://orcid.org/0000-0003-3952-5296
L
Mirow
Günther
http://orcid.org/0000-0001-9131-5275
G
Winde
Hans
http://orcid.org/0000-0002-5217-8324
H
Lippert
minimally invasive; quality study; single-incision