Abstract
Background
Patients with obesity have a higher risk of trocar site hernia. The objective of the present study was to compare a standard suture passer versus the neoClose® device for port site fascial closure in patients with obesity undergoing laparoscopic bariatric surgery.
Methods
This is a randomized, controlled trial with two parallel arms. Thirty five patients with BMI ≥ 35 kg/m2 and undergoing laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass were randomized to each group. Port site fascial closure for trocars ≥ 10 mm was performed with the neoClose® device in the study group and the standard suture passer in the control group. Primary outcomes were time required to complete closure and intensity of postoperative pain at the fascial closure sites. Secondary outcomes were intraabdominal needle depth and incidence of trocar site hernia.
Results
The use of the neoClose® device resulted in shorter closure times (20.2 vs 30.0 s, p = 0.0002), less pain (0.3 vs 0.9, p = 0.002) at port closure sites, and decreased needle depth (3.3 cm vs 5.2 cm, p < 0.0001) compared to the standard suture passer. There was no trocar site hernia at the one-year follow-up in either group.
Conclusions
Use of the neoClose® device resulted in faster fascial closure times, decreased intraoperative needle depth, and decreased postoperative abdominal pain at 1 week as compared to the standard suture passer. These data need to be confirmed on larger cohorts of patients with longer follow-up.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
Change history
04 September 2019
After careful review, the authors have noticed the following mistakes in the article entitled “Trocar site closure with a novel anchor based (neoClose®) system versus standard suture closure: A prospective randomized controlled trial”: - Correct closure times are 19.9 seconds (SD 9.9) for the study group and 31.0 seconds (SD 20.1) for the control group (initial incorrect values were 20.2 seconds (SD 10.1) and 30 seconds (SD 19.1) respectively). The new correct P-value is <0.0001 (initial incorrect P-value was 0.0002). - Correct maximal needle depth values are 3.2 cm (SD 0.93) for the study group and 4.9 cm (SD 1.97) for the control group (initial incorrect values were 3.3 cm (SD 0.9) and 5.2 cm (SD 1.6) respectively). P-value remains unchanged at <0.0001. For these two outcomes, some values of control group patients were mistakenly included in the study group. These errors only marginally affected the mean and standard deviation values. Statistical significance of the results was not affected and the conclusions of the study remain unchanged.
References
Erdas E, Dazzi C, Secchi F, Aresu S, Pitzalis A, Barbarossa M, Garau A, Murgia A, Contu P, Licheri S, Pomata M, Farina G (2012) Incidence and risk factors for trocar site hernia following laparoscopic cholecystectomy: a long-term follow-up study. Hernia 16(4):431–437. https://doi.org/10.1007/s10029-012-0929-y
Helgstrand F, Rosenberg J, Bisgaard T (2011) Trocar site hernia after laparoscopic surgery: a qualitative systematic review. Hernia 15(2):113–121. https://doi.org/10.1007/s10029-010-0757-x
Muysoms FE, Antoniou SA, Bury K, Campanelli G, Conze J, Cuccurullo D, de Beaux AC, Deerenberg EB, East B, Fortelny RH, Gillion JF, Henriksen NA, Israelsson L, Jairam A, Janes A, Jeekel J, Lopez-Cano M, Miserez M, Morales-Conde S, Sanders DL, Simons MP, Smietanski M, Venclauskas L, Berrevoet F, European Hernia S (2015) European Hernia Society guidelines on the closure of abdominal wall incisions. Hernia 19(1):1–24. https://doi.org/10.1007/s10029-014-1342-5
Swank HA, Mulder IM, la Chapelle CF, Reitsma JB, Lange JF, Bemelman WA (2012) Systematic review of trocar-site hernia. Br J Surg 99(3):315–323. https://doi.org/10.1002/bjs.7836
Tonouchi H, Ohmori Y, Kobayashi M, Kusunoki M (2004) Trocar site hernia. Arch Surg 139(11):1248–1256. https://doi.org/10.1001/archsurg.139.11.1248
Owens M, Barry M, Janjua AZ, Winter DC (2011) A systematic review of laparoscopic port site hernias in gastrointestinal surgery. Surgeon 9(4):218–224. https://doi.org/10.1016/j.surge.2011.01.003
Sugerman HJ, Kellum JM Jr, Reines HD, DeMaria EJ, Newsome HH, Lowry JW (1996) Greater risk of incisional hernia with morbidly obese than steroid-dependent patients and low recurrence with prefascial polypropylene mesh. Am J Surg 171(1):80–84. https://doi.org/10.1016/S0002-9610(99)80078-6
Lee DY, Rehmani SS, Guend H, Park K, Ross RE, Alkhalifa M, McGinty JJ, Teixeira JA (2013) The incidence of trocar-site hernia in minimally invasive bariatric surgery: a comparison of multi versus single-port laparoscopy. Surg Endosc 27(4):1287–1291. https://doi.org/10.1007/s00464-012-2597-5
Shin JH, Howard FM (2012) Abdominal wall nerve injury during laparoscopic gynecologic surgery: incidence, risk factors, and treatment outcomes. J Minim Invasive Gynecol 19(4):448–453. https://doi.org/10.1016/j.jmig.2012.03.009
(2014). https://www.accessdata.fda.gov/cdrh_docs/pdf14/K142903.pdf. Accessed 7 Mar 2019
Walker PAS SK, Wilson EB (2016) Preclinical study evaluating a novel trocar site closure system. Open Access Surg 9:29–35
Shah SK, Walker PA, Snyder BE, Wilson EB (2015) Essentials and future directions of robotic bariatric surgery. In: Kroh MCS (ed) Essentials of robotic surgery. Springer, Switzerland, pp 73–80
Poole NA, Al Atar A, Kuhanendran D, Bidlake L, Fiennes A, McCluskey S, Nussey S, Bano G, Morgan JF (2005) Compliance with surgical after-care following bariatric surgery for morbid obesity: a retrospective study. Obes Surg 15(2):261–265. https://doi.org/10.1381/0960892053268499
Acknowledgements
This research was supported by a research grant from Neosurgical (Newton, MA, USA). Neosurgical did not participate in data analysis, interpretation, or the writing of this manuscript.
Funding
This research was supported by a research grant from Neosurgical (Newton, MA, USA).
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Disclosures
Mustafa Alibhai, MD: Honoraria from Intuitive Surgical (Educational); Brad E. Snyder, MD: Honoraria from Intuitive Surgical (Proctor); Todd D. Wilson, MD: Consultant for Bard, EndoEvolution, and Olympus; Sheilendra S. Mehta, MD: Honoraria from Intuitive Surgical (Proctor); Peter A. Walker, MD: Research grant funding from Neosurgical; Shinil K. Shah, DO: Honoraria from Gore and C-SATS, and Research grant funding from Medigus and Intuitive Surgical; Erik B. Wilson, MD: Teaching honoraria from Intuitive Surgical, Olympus, Gore, Apollo, and Ethicon. Pouya Iranmanesh, MD; Angielyn R. Rivera; Kulvinder S. Bajwa, MD; Melissa M. Felinski, DO; Connie L. Klein, NP; and Kavita D. Chandwani, MD, DrPH have no conflict of interests or financial ties to disclose.
Additional information
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Rights and permissions
About this article
Cite this article
Iranmanesh, P., Rivera, A.R., Bajwa, K.S. et al. Trocar site closure with a novel anchor-based (neoClose®) system versus standard suture closure: a prospective randomized controlled trial. Surg Endosc 34, 1270–1276 (2020). https://doi.org/10.1007/s00464-019-06891-y
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00464-019-06891-y