title: Novel prototype sewing device, EndoSew®, for minimally invasive surgery: an extracorporeal ileal conduit construction pilot study in 10 patients.
abstract: WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: The EndoSew(®) prototype was first tested in a porcine model several years ago. The investigators found it both simple to master and reliable, its greatest advantage being a 2.4-fold time saving compared with straight laparoscopic suturing. In addition to that publication, there is a single case report describing the performance of an open EndoSew(®) suture to close parts (16 cm) of an ileal neobladder. The time for suturing the 16 cm ileum was 25 min, which is in line with our experience. The knowledge on this subject is limited to these two publications. We report on the first consecutive series of ileal conduits performed in humans using the novel prototype sewing device EndoSew(®). The study shows that the beginning and the end of the suture process represent the critical procedural steps. It also shows that, overall, the prototype sewing machine has the potential to facilitate the intracorporeal suturing required in reconstructive urology for construction of urinary diversions.
  
  
  OBJECTIVE
  To evaluate the feasibility and safety of the novel prototype sewing device EndoSew(®) in placing an extracorporeal resorbable running suture for ileal conduits.
  
  
  METHODS
  We conducted a prospective single-centre pilot study of 10 consecutive patients undergoing ileal conduit, in whom the proximal end of the ileal conduit was closed extracorporeally using an EndoSew(®) running suture. The primary endpoint was the safety of the device and the feasibility of the sewing procedure which was defined as a complete watertight running suture line accomplished by EndoSew(®) only. Watertightness was assessed using methylene blue intraoperatively and by loopography on postoperative days 7 and 14. Secondary endpoints were the time requirements and complications ≤30 days after surgery.
  
  
  RESULTS
  A complete EndoSew(®) running suture was feasible in nine patients; the suture had to be abandoned in one patient because of mechanical failure. In three patients, two additional single freehand stitches were needed to anchor the thread and to seal tiny leaks. Consequently, all suture lines in 6/10 patients were watertight with EndoSew(®) suturing alone and in 10/10 patients after additional freehand stitches. The median (range) sewing time was 5.5 (3-10) min and the median (range) suture length was 4.5 (2-5.5) cm. There were no suture-related complications.
  
  
  CONCLUSIONS
  The EndoSew(®) procedure is both feasible and safe. After additional freehand stitches in four patients all sutures were watertight. With further technical refinements, EndoSew(®) has the potential to facilitate the intracorporeal construction of urinary diversions.
authors.affiliation: Department of Urology, University of Bern, Bern, Switzerland.
authors.forename: Beat
authors.initials: B
authors.lastname: Roth
authors.forename: Frédéric D
authors.initials: FD
authors.lastname: Birkhäuser
authors.forename: George N
authors.initials: GN
authors.lastname: Thalmann
authors.forename: Pascal
authors.initials: P
authors.lastname: Zehnder
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D019060:Minimally Invasive Surgical Procedures; D010865:Pilot Projects; D011446:Prospective Studies; D013537:Sutures; D014547:Urinary Diversion / Q000295:instrumentation* / Q000379:methods*
keywords: EndoSew®; bladder cancer; cystectomy; laparoscopic running suture; urinary diversion