Surgical Endoscopy

, Volume 27, Issue 11, pp 4284–4290 | Cite as

Prospective, randomized clinical trial comparing the use of a single-port device with that of a flexible endoscope with no other device for transumbilical cholecystectomy: LLATZER-FSIS pilot study

  • José Noguera
  • Silvia Tejada
  • Carmen Tortajada
  • Anna Sánchez
  • José Muñoz



Natural orifice transumbilical endoscopic surgery (NOTES) is a technique still in experimental development that requires clinical trials to assess its safety and efficacy. We present a pilot prospective, randomized, three-arm clinical trial of 1-year duration that was conducted as a noninferiority trial comparing single-incision laparoscopic surgery (SILS) and flexible single-incision surgery (FSIS) with conventional laparoscopy for elective cholecystectomy (NCT01558414).


Sixty patients between aged 18 and 65 years who were eligible for elective cholecystectomy were randomly assigned in a 1:1:1 ratio (n = 20 per group): group A (SILS), single-incision endoscopic surgery using a transumbilical SILS™ device; group B (FSIS), single-incision transumbilical surgery using a flexible endoscope; and group C (CL), conventional laparoscopy. The main outcome variable of the study was “parietal complications” (wound infection, bleeding, and ventral hernia). The analysis was by intention to treat and attritions were not replaced.


Cholecystectomy was performed in 100 % of the cases; perioperative complications occurred in only 1.6 % of the cases, and umbilical surgical wound infection in 3.33 %, with no differences between groups. After a minimum follow-up of 1 year, no differences were noted in the frequency of parietal complications and no ventral hernias occurred. Postoperative pain, hospital length of stay, and downtime from work were similar in all three groups. Surgical time was longer in cases in which a single-incision transumbilical approach was used (58.95 min for SILS and 54.15 for FSIS vs. 49.21 for laparoscopy).


Single-incision transumbilical approaches are not inferior for safety or effectiveness compared with conventional laparoscopy. The transumbilical approach using a flexible endoscope is just as effective and safe as the other two procedures and is a promising single-incision approach.


FSIS NOTES SILS Cholecystectomy Laparoscopy Minimally invasive surgery 


  1. 1.
    Noguera JF, Cuadrado A, Sánchez-Margallo FM, Dolz C, Asencio JM, Olea JM, Morales R, Lozano L, Vicens JC (2011) Emergency transvaginal hybrid natural orifice transluminal endoscopic surgery. Endoscopy 43:442–444PubMedCrossRefGoogle Scholar
  2. 2.
    Cuadrado-Garcia A, Noguera JF, Olea-Martinez JM, Morales R, Dolz C, Lozano L, Vicens JC, Pujol JJ (2011) Hybrid natural orifice transluminal endoscopic cholecystectomy: prospective human series. Surg Endosc 25:19–22PubMedCrossRefGoogle Scholar
  3. 3.
    Noguera J, Dolz C, Cuadrado A, Olea J, Vilella A, Morales R (2009) Hybrid transvaginal cholecystectomy, NOTES, and minilaparoscopy: analysis of a prospective clinical series. Surg Endosc 23:876–881PubMedCrossRefGoogle Scholar
  4. 4.
    Moreno Sanz C, Noguera Aguilar JF, Herrero Bogajo ML, Morandeira Rivas A, García Llorente C, Tadeo Ruiz G, Cuadrado García A, Picazo Yeste JS (2010) Cirugía laparoscópica a través de incisión única. Cir Esp 88:12–17PubMedCrossRefGoogle Scholar
  5. 5.
    Noguera J, Dolz C, Cuadrado A, Olea J, García J (2013) Flexible single-incision surgery: a fusion technique. Surg Innov 20:256–259PubMedCrossRefGoogle Scholar
  6. 6.
    Kalloo AN, Singh VK, Jagannath SB, Niiyama H, Hill SL, Vaughn CA, Magee CA, Kantsevoy SV (2004) Flexible transgastric peritoneoscopy: a novel approach to diagnostic and therapeutic interventions in the peritoneal cavity. Gastrointest Endosc 60:114–117PubMedCrossRefGoogle Scholar
  7. 7.
    Jagannath SB, Kantsevoy SV, Vaughn CA, Chung SS, Cotton PB, Gostout CJ, Hawes RH, Pasricha PJ, Scorpio DG, Magee CA, Pipitone LJ, Kalloo AN (2005) Peroral transgastric endoscopic ligation of fallopian tubes with long-term survival in a porcine model. Gastrointest Endosc 61:449–453PubMedCrossRefGoogle Scholar
  8. 8.
    Kantsevoy SV, Jagannath SB, Niiyama H, Chung SS, Cotton PB, Gostout CJ, Hawes RH, Pasricha PJ, Magee CA, Vaughn CA, Barlow D, Shimonaka H, Kalloo AN (2005) Endoscopic gastrojejunostomy with survival in a porcine model. Gastrointest Endosc 62:287–292PubMedCrossRefGoogle Scholar
  9. 9.
    Wagh MS, Merrifield BF, Thompson CC (2005) Endoscopic transgastric abdominal exploration and organ resection: initial experience in a porcine model. Clin Gastroenterol Hepatol 3:892–896PubMedCrossRefGoogle Scholar
  10. 10.
    Swanstrom LL, Kozarek R, Pasricha PJ, Gross S, Birkett D, Park PO, Saadat V, Ewers R, Swain P (2005) Development of a new access device for transgastric surgery. J Gastrointest Surg 9:1129–1136PubMedCrossRefGoogle Scholar
  11. 11.
    Park PO, Bergström M, Ikeda K, Fritscher-Ravens A, Swain P (2005) Experimental studies of transgastric gallbladder surgery: cholecystectomy and cholecystogastric anastomosis (videos). Gastrointest Endosc 61:601–606PubMedCrossRefGoogle Scholar
  12. 12.
    Zorrón R, Filgueiras M, Maggioni LC, Pombo L, Lopez Carvalho G, Lacerda Oliveira A (2007) NOTES. Transvaginal cholecystectomy: report of the first case. Surg Innov 14:279–283PubMedCrossRefGoogle Scholar
  13. 13.
    Zorrón R, Maggioni LC, Pombo L, Oliveira AL, Carvalho GL, Filgueiras M (2008) NOTES transvaginal cholecystectomy: preliminary clinical application. Surg Endosc 22:542–547PubMedCrossRefGoogle Scholar
  14. 14.
    Bessler M, Stevens P, Milone L, Parikh M, Fowler D (2007) Transvaginal laparoscopically assisted endoscopic cholecystectomy: a hybrid approach to natural orifice surgery. Gastrointest Endosc 66:1243–1245PubMedCrossRefGoogle Scholar
  15. 15.
    Marescaux J, Dallemagne B, Perretta S, Wattiez A, Mutter D, Coumaros D (2007) Surgery without scars: report of transluminal cholecystectomy in a human being. Arch Surg 142:823–826PubMedCrossRefGoogle Scholar
  16. 16.
    Branco Filho AJ, Noda RW, Kondo W, Kawahara N, Rangel M, Branco AW (2007) Initial experience with hybrid transvaginal cholecystectomy. Gastrointest Endosc 66:1245–1248PubMedCrossRefGoogle Scholar
  17. 17.
    Branco AW, Branco Filho AJ, Kondo W, Noda RW, Kawahara N, Camargo AA, Stunitz LC, Valente J, Rangel M (2008) Hybrid transvaginal cholecystectomy. Eur Urol 53:1290–1294PubMedCrossRefGoogle Scholar
  18. 18.
    Dolz C, Noguera JF, Martín A, Vilella A, Cuadrado A (2007) Transvaginal cholecystectomy (NOTES) combined with minilaparoscopy. Rev Esp Enferm Dig 99:698–702PubMedCrossRefGoogle Scholar
  19. 19.
    Rolanda C, Lima E, Pêgo JM, Henriques-Coelho T, Silva D, Moreira I, Macedo G, Carvalho JL, Correia-Pinto J (2007) Third-generation cholecystectomy by natural orifices: transgastric and transvesical combined approach (with video). Gastrointest Endosc 65:111–117PubMedCrossRefGoogle Scholar
  20. 20.
    Hensel M, Schernikau U, Schmidt A, Arlt G (2011) Surgical outcome and midterm follow-up after transvaginal NOTES hybrid cholecystectomy: analysis of a prospective clinical series. J Laparoendosc Adv Surg Tech A 21:101–106PubMedCrossRefGoogle Scholar
  21. 21.
    Zornig C, Siemssen L, Emmermann A, Alm M, von Waldenfels HA, Felixmüller C, Mofid H (2011) NOTES cholecystectomy: matched-pair analysis comparing the transvaginal hybrid and conventional laparoscopic techniques in a series of 216 patients. Surg Endosc 25:1822–1826PubMedCrossRefGoogle Scholar
  22. 22.
    Alptekin H, Yilmaz H, Acar F, Kafali ME, Sahin M (2012) Incisional hernia rate may increase after single-port cholecystectomy. J Laparoendosc Adv Surg Tech A 22:731–737PubMedCrossRefGoogle Scholar
  23. 23.
    Krajinovic K, Ickrath P, Germer CT, Reibetanz J (2011) Trocar-site hernia after single-port cholecystectomy: not an exceptional complication? J Laparoendosc Adv Surg Tech A 21:919–921PubMedCrossRefGoogle Scholar
  24. 24.
    Zorron R, Palanivelu C, Galvão Neto MP, Ramos A, Salinas G, Burghardt J, DeCarli L, Henrique Sousa L, Forgione A, Pugliese R, Branco AJ, Balashanmugan TS, Boza C, Corcione F, D’Avila Avila F, Arturo Gómez N, Galváo Ribeiro PA, Martins S, Filgueiras M, Gellert K, Wood Branco A, Kondo W, Inacio Sanseverino J, de Sousa JA, Saavedra L, Ramírez E, Campos J, Sivakumar K, Rajan PS, Jategaonkar PA, Ranagrajan M, Parthasarathi R, Senthilnathan P, Prasad M, Cuccurullo D, Müller V (2010) International multicenter trial on clinical natural orifice surgery—NOTES IMTN study: preliminary results of 362 patients. Surg Innov 17:142–158PubMedCrossRefGoogle Scholar
  25. 25.
    Kilian M, Raue W, Menenakos C, Wassersleben B, Hartmann J (2011) Transvaginal-hybrid vs. single-port-access vs. ‘conventional’ laparoscopic cholecystectomy: a prospective observational study. Langenbecks Arch Surg 396:709–715PubMedCrossRefGoogle Scholar
  26. 26.
    Wagner MJ, Kern H, Hapfelmeier A, Mehler J, Schoenberg MH (2013) Single-port cholecystectomy versus multi-port cholecystectomy: a prospective cohort study with 222 patients. World J Surg 37:991–998PubMedCrossRefGoogle Scholar
  27. 27.
    Pan MX, Jiang ZS, Cheng Y, Xu XP, Zhang Z, Qin JS, He GL, Xu TC, Zhou CJ, Liu HY, Gao Y (2013) Single-incision vs three-port laparoscopic cholecystectomy: prospective randomized study. World J Gastroenterol 19:394–398PubMedCrossRefGoogle Scholar
  28. 28.
    Ostlie DJ, Juang OO, Iqbal CW, Sharp SW, Snyder CL, Andrews WS, Sharp RJ, Holcomb GW 3rd, St Peter SD (2013) Single incision versus standard 4-port laparoscopic cholecystectomy: a prospective randomized trial. J Pediatr Surg 48:209–214PubMedCrossRefGoogle Scholar
  29. 29.
    Luna RA, Nogueira DB, Varela PS, Rodrigues Neto Ede O, Norton MJ, Ribeiro Ldo C, Peixoto AM, de Mendonça YL, Bendet I, Fiorelli RA, Dolan JP (2013) A prospective, randomized comparison of pain, inflammatory response, and short-term outcomes between single port and laparoscopic cholecystectomy. Surg Endosc 27:1254–1259PubMedCrossRefGoogle Scholar
  30. 30.
    Saad S, Strassel V, Sauerland S (2013) Randomized clinical trial of single-port, minilaparoscopic and conventional laparoscopic cholecystectomy. Br J Surg 100:339–349PubMedCrossRefGoogle Scholar
  31. 31.
    Trastulli S, Cirocchi R, Desiderio J, Guarino S, Santoro A, Parisi A, Noya G, Boselli C (2013) Systematic review and meta-analysis of randomized clinical trials comparing single-incision versus conventional laparoscopic cholecystectomy. Br J Surg 100:191–208PubMedCrossRefGoogle Scholar
  32. 32.
    Sasaki A, Ogawa M, Tono C, Obara S, Hosoi N, Wakabayashi G (2012) Single-port versus multiport laparoscopic cholecystectomy: a prospective randomized clinical trial. Surg Laparosc Endosc Percutan Tech 22:396–399PubMedCrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media New York 2013

Authors and Affiliations

  • José Noguera
    • 1
  • Silvia Tejada
    • 2
  • Carmen Tortajada
    • 3
  • Anna Sánchez
    • 2
  • José Muñoz
    • 2
  1. 1.Unidad Terapias Mínimamente Invasivas, Servicio de Cirugía GeneralConsorcio Hospital General Universitario de ValenciaValenciaSpain
  2. 2.Servicio de CirugíaHospital Son LlàtzerPalmaSpain
  3. 3.Consorcio Hospital General Universitario de ValenciaValenciaSpain

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