The TICAP-Study (titanium clips for appendicular stump closure): A prospective multicentre observational study on appendicular stump closure with an innovative titanium clip

Alexander Rickert, Colin M Krüger, Norbert Runkel, Andreas Kuthe, Jörg Köninger, Boris Jansen-Winkeln, Carsten N Gutt, Daniel R Marcus, Brian Hoey, Moritz N Wente, Peter Kienle, Alexander Rickert, Colin M Krüger, Norbert Runkel, Andreas Kuthe, Jörg Köninger, Boris Jansen-Winkeln, Carsten N Gutt, Daniel R Marcus, Brian Hoey, Moritz N Wente, Peter Kienle

Abstract

Background: To evaluate the effectiveness and safety of the DS Titanium Ligation Clip for appendicular stump closure in laparoscopic appendectomy.

Methods: Overall, 502 patients undergoing laparoscopic appendectomy were recruited for this observational multicentre study in nine study centres between October 2011 and July 2013. The clip was finally applied in 390 patients. Primary outcome variables were feasibility of the clip, intra-abdominal surgical site (abscesses, stump leakages) and superficial wound infections. Patients were followed 30 days after surgery.

Results: The clip was applicable in nearly 80 % of patients. Reasons for not applying the clip were mainly an inflamed caecum or a too large diameter of the appendix base. Superficial wound infections were found in nine (2.31 %), intra-abdominal abscesses in five (1.28 %), appendicular stump leak in one (0.26 %), and other adverse events in 22 (5.64 %) patients. In total, 12 (3.08 %) patients were re-admitted to hospital for treatment. Seven re-admissions were surgery-related; ten (2.56 %) patients had to be re-operated. One patient died during the course of the study due to persisting peritonitis (mortality 0.26 %).

Conclusions: The results suggest that the DS Titanium Ligation Clip is a safe and effective option in securing the appendicular stump in laparoscopic appendectomy. The complication rates found with the use of the DS-Clip are comparable to the rates in the literature when other methods are used.

Trial registration: NCT01734837 .

Figures

Fig. 1
Fig. 1
DS-Clip. The Aesculap DS Titanium Ligation Clips are made of pure titanium. They are non-ferromagnetic and suitable for MRI. The design of the DS-Clip is characterized by two parallel and interconnected shanks, which prevent axial displacement and clip scissoring. The pyramid-shaped inner surface increases the contact surface of the tissue, ensuring a strong grip
Fig. 2
Fig. 2
Flow of patients. In all 502 recruited patients, the intended treatment was laparoscopic appendectomy with the DS-Clips to be used for the ligation of the appendix (recruited patient). All patients actually treated with the DS-Clip were considered in the DS-Clipgroup, n = 390

References

    1. Sahm M, Koch A, Schmidt U, Wolff S, Pross M, Gastinger I, et al. Acute appendicitis - clinical health-service research on the current surgical therapy. Zentralblatt für Chir. 2013;138(3):270–7.
    1. Sauerland S, Jaschinski T, Neugebauer EA. Laparoscopic versus open surgery for suspected appendicitis. Cochrane Database Syst Rev. 2010;10:CD001546.
    1. Kazemier G. in’t Hof KH, Saad S, Bonjer HJ, Sauerland S. Securing the appendiceal stump in laparoscopic appendectomy: evidence for routine stapling? Surg Endosc. 2006;20(9):1473–6. doi: 10.1007/s00464-005-0525-7.
    1. Sajid MS, Rimple J, Cheek E, Baig MK. Use of endo-GIA versus endo-loop for securing the appendicular stump in laparoscopic appendicectomy: a systematic review. Surg Laparosc Endosc Percutan Tech. 2009;19(1):11–5. doi: 10.1097/SLE.0b013e31818a66ab.
    1. Gorter RR, Heij HA, Eker HH, Kazemier G. Laparoscopic appendectomy: State of the art. Tailored approach to the application of laparoscopic appendectomy? Best Pract Res Clin Gastroenterol. 2014;28(1):211–24. doi: 10.1016/j.bpg.2013.11.016.
    1. Rickert A, Bönninghoff R, Post S, Walz M, Runkel N, Kienle P. Appendix stump closure with titanium clips in laparoscopic appendectomy. Langenbecks Arch Surg Dtsch Ges Für Chir. 2012;397(2):327–31. doi: 10.1007/s00423-011-0869-5.
    1. Ohtani H, Tamamori Y, Arimoto Y, Nishiguchi Y, Maeda K, Hirakawa K. Meta-analysis of the results of randomized controlled trials that compared laparoscopic and open surgery for acute appendicitis. J Gastrointest Surg Off J Soc Surg Aliment Tract. 2012;16(10):1929–39. doi: 10.1007/s11605-012-1972-9.
    1. Li X, Zhang J, Sang L, Zhang W, Chu Z, Li X, et al. Laparoscopic versus conventional appendectomy--a meta-analysis of randomized controlled trials. BMC Gastroenterol. 2010;10:129. doi: 10.1186/1471-230X-10-129.
    1. Masoomi H, Mills S, Dolich MO, Ketana N, Carmichael JC, Nguyen NT, et al. Comparison of outcomes of laparoscopic versus open appendectomy in adults: data from the Nationwide Inpatient Sample (NIS), 2006–2008. J Gastrointest Surg Off J Soc Surg Aliment Tract. 2011;15(12):2226–31. doi: 10.1007/s11605-011-1613-8.
    1. Beldi G, Vorburger SA, Bruegger LE, Kocher T, Inderbitzin D, Candinas D. Analysis of stapling versus endoloops in appendiceal stump closure. Br J Surg. 2006;93(11):1390–3. doi: 10.1002/bjs.5474.
    1. Cristalli BG, Izard V, Jacob D, Levardon M. Laparoscopic appendectomy using a clip applier. Surg Endosc. 1991;5(4):176–8. doi: 10.1007/BF02653257.
    1. Alis H, Gonenc M, Deniztas C, Kapan S, Turhan AN. Metal endoclips for the closure of the appendiceal stump in laparoscopic appendectomy. Tech Coloproctology. 2012;16(2):139–41. doi: 10.1007/s10151-011-0764-7.
    1. Gonenc M, Gemici E, Kalayci MU, Karabulut M, Turhan AN, Alis H. Intracorporeal knotting versus metal endoclip application for the closure of the appendiceal stump during laparoscopic appendectomy in uncomplicated appendicitis. J Laparoendosc Adv Surg Tech A. 2012;22(3):231–5. doi: 10.1089/lap.2011.0335.
    1. Ates M, Dirican A, Ince V, Ara C, Isik B, Yilmaz S. Comparison of intracorporeal knot-tying suture (polyglactin) and titanium endoclips in laparoscopic appendiceal stump closure: a prospective randomized study. Surg Laparosc Endosc Percutan Tech. 2012;22(3):226–31. doi: 10.1097/SLE.0b013e31824f25cd.
    1. Delibegović S. The use of a single Hem-o-lok clip in securing the base of the appendix during laparoscopic appendectomy. J Laparoendosc Adv Surg Tech A. 2012;22(1):85–7. doi: 10.1089/lap.2011.0348.
    1. Akbiyik F, Senel E, Bayram-Kabacam G, Demirkan H, Atayurt H, Tiryaki T. A comparison of polymer clips and endoloop applications for securing the appendiceal stump during laparoscopic surgery in children. Surg Laparosc Endosc Percutan Tech. 2011;21(5):349–52. doi: 10.1097/SLE.0b013e31822d68ca.
    1. Hue CS, Kim JS, Kim KH, Nam S-H, Kim KW. The usefulness and safety of Hem-o-lok clips for the closure of appendicular stump during laparoscopic appendectomy. J Korean Surg Soc. 2013;84(1):27–32. doi: 10.4174/jkss.2013.84.1.27.
    1. Partecke LI, Kessler W, von Bernstorff W, Diedrich S, Heidecke C-D, Patrzyk M. Laparoscopic appendectomy using a single polymeric clip to close the appendicular stump. Langenbecks Arch Surg Dtsch Ges Für Chir. 2010;395(8):1077–82. doi: 10.1007/s00423-010-0671-9.
    1. Hanssen A, Plotnikov S, Dubois R. Laparoscopic appendectomy using a polymeric clip to close the appendicular stump. JSLS J Soc Laparoendosc Surg Soc Laparoendosc Surg. 2007;11(1):59–62.
    1. Wente MN, Waleczek H. Strategy for avoidance of negative appendectomies. Chir Z Für Alle Geb Oper Medizen. 2009;80(7):588–93. doi: 10.1007/s00104-009-1686-z.
    1. Davila D, Russek K, Franklin ME., Jr Laparoscopic appendectomy: vascular control of the appendicular artery using monopolar cauterization versus clips. J Laparoendosc Adv Surg Tech A. 2012;22(2):165–7. doi: 10.1089/lap.2010.0312.
    1. Antoniou SA, Koch OO, Antoniou GA, Lasithiotakis K, Chalkiadakis GE, Pointner R, et al. Meta-analysis of randomized trials on single-incision laparoscopic versus conventional laparoscopic appendectomy. Am J Surg. 2014;207(4):613–22. doi: 10.1016/j.amjsurg.2013.07.045.
    1. Markar SR, Karthikesalingam A, Di Franco F, Harris AM. Systematic review and meta-analysis of single-incision versus conventional multiport appendectomy. Br J Surg. 2013;100(13):1709–18. doi: 10.1002/bjs.9296.
    1. Swank HA, van Rossem CC, van Geloven AW, in’t Hof KH, Kazemier G, Meijerink WJHJ, et al. Endostapler or endoloops for securing the appendiceal stump in laparoscopic appendectomy: a retrospective cohort study. Surg Endosc. 2014;28(2):576–83. doi: 10.1007/s00464-013-3207-x.
    1. Sahm M, Pross M, Otto R, Koch A, Gastinger I, Lippert H. Clinical Health Service Research on the Surgical Therapy of Acute Appendicitis: Comparison of Outcomes Based on 3 German Multicenter Quality Assurance Studies Over 21 Years. Ann Surg. 2015 Jan 5 [Epub ahead of print].

Source: PubMed

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