Pouya Iranmanesh1, Angielyn R Rivera1, Kulvinder S Bajwa1, Mustafa Alibhai2,3, Brad E Snyder1, Todd D Wilson1, Melissa M Felinski1, Sheilendra S Mehta4, Kavita D Chandwani1, Connie L Klein1, Peter A Walker5, Shinil K Shah6,7, Erik B Wilson1. 1. Department of Surgery, McGovern Medical School, University of Texas Health Science Center at Houston, 6431 Fannin Street, MSB 4.156, Houston, TX, 77030, USA. 2. Surgical Group of North Texas, Grapevine, TX, USA. 3. Surgical Group of North Texas, Irving, TX, USA. 4. Texas Laparoscopic Consultants, Houston, TX, USA. 5. Health First Medical Group, Rockledge, FL, USA. 6. Department of Surgery, McGovern Medical School, University of Texas Health Science Center at Houston, 6431 Fannin Street, MSB 4.156, Houston, TX, 77030, USA. shinil.k.shah@uth.tmc.edu. 7. Michael E. DeBakey Institute for Comparative Cardiovascular Science and Biomedical Devices, Texas A&M University, College Station, TX, USA. shinil.k.shah@uth.tmc.edu.
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.
RCT Entities:
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.
Entities:
Keywords:
Incisional hernia; Port closure; Trocar hernia
Authors: David Y Lee; Sadiq S Rehmani; Hamza Guend; Koji Park; Ronald E Ross; Mohammed Alkhalifa; James J McGinty; Julio A Teixeira Journal: Surg Endosc Date: 2012-12-12 Impact factor: 4.584
Authors: Norman A Poole; Ashraf Al Atar; Dammayanthi Kuhanendran; Louise Bidlake; Alberic Fiennes; Sara McCluskey; Stephen Nussey; Gal Bano; John F Morgan Journal: Obes Surg Date: 2005-02 Impact factor: 4.129
Authors: E Erdas; C Dazzi; F Secchi; S Aresu; A Pitzalis; M Barbarossa; A Garau; A Murgia; P Contu; S Licheri; M Pomata; G Farina Journal: Hernia Date: 2012-06-20 Impact factor: 4.739
Authors: F E Muysoms; S A Antoniou; K Bury; G Campanelli; J Conze; D Cuccurullo; A C de Beaux; E B Deerenberg; B East; R H Fortelny; J-F Gillion; N A Henriksen; L Israelsson; A Jairam; A Jänes; J Jeekel; M López-Cano; M Miserez; S Morales-Conde; D L Sanders; M P Simons; M Śmietański; L Venclauskas; F Berrevoet Journal: Hernia Date: 2015-01-25 Impact factor: 4.739
Authors: Kovi E Bessoff; Jeff Choi; Christopher J Wolff; Aditi Kashikar; Garrison M Carlos; Luke Caddell; Rida I Khan; Christopher D Stave; David A Spain; Joseph D Forrester Journal: Surg Open Sci Date: 2021-08-26