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Single-Incision Multiport/Single Port Laparoscopic Abdominal Surgery (SILAP): A Prospective Multicenter Observational
Rene Mantke1, Markus Diener, Siegfried Kropf
1Brandenburg Medical School, Department of Surgery, University Hospital Brandenburg / Havel, Brandenburg, Germany. mantke.mhb@klinikum-brandenburg.de.
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.
Trial Registration:
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).
Insights
This study demonstrates the feasibility and safety of single-incision laparoscopic abdominal surgery (SILAP). The SILAP study aims to provide a large dataset to support evidence-based surgical decision-making for this minimally invasive approach.
Area of Science:
- Minimally Invasive Surgery
- Surgical Quality Improvement
- Laparoscopic Surgery
Background:
- Advancements in surgical techniques and instruments are driving a trend towards fewer abdominal incisions.
- While studies show single-incision surgery is feasible and safe, large-scale data is lacking.
- Existing evidence is insufficient for evidence-based surgical decision-making.
Purpose of the Study:
- To establish a large prospective multicenter observational dataset on single-incision laparoscopic abdominal surgery (SILAP).
- To assess the feasibility, safety, external validity, clinical relevance, and patient perspective of SILAP.
- To supplement current evidence and inform surgical decision-making.
Main Methods:
- International prospective multicenter observational quality study.
- Monitoring mortality, morbidity, surgical and postoperative complications, patient characteristics, and technical aspects.
- Anticipated participation of over 100 centers and 5000 patients.
Main Results:
- Enrollment began January 1, 2013, with completion by December 31, 2018.
- As of January 2016, 2119 patients were included.
- 106 German centers registered, with 27 highly active.
Conclusions:
- The study will generate a significant dataset on the feasibility and safety of single-incision surgery.
- International expansion and recruitment of centers outside Germany are recommended.
- This data will support evidence-based practice in minimally invasive surgery.
