Multicentric pragmatic randomized controlled trial of mesh fixation system in primary and recurrent ventral hernia repair
10 affiliations
- 1Academic General Surgery Unit “F. Paccione”, Department of Precision and Regenerative Medicine and Jonian Area (DiMePRe-J), University of Bari Aldo Moro Medical School, Bari (BA), Italy
- 2Department of Surgery, Academy of Applied Medical and Social Sciences - AMiSNS, Elblag, Poland
- 3General Surgery Unit, S. Giuseppe Di Copertino Hospital, Copertino, Lecce (LE), Italy
- 4Department of Surgery, Sapienza University, Rome, Italy
- 5Laparoscopic and Robotic Surgery Unit, Monaldi Hospital, Naples, Italy
- 6General Surgery Unit, Scorrano Hospital Centre, Scorrano, Lecce (LE), Italy
- 7General Surgery Unit, Casarano Hospital Centre, Casarano, Lecce (LE), Italy
- 8General and Abdominal Wall Surgery Unit, “Ospedale SS Annunziata Di Cento”, Ferrara, Italy
- 9Department of Medicine, LUM University, Casamassima, Bari (BA), Italy
- 10General Surgery, Day and Week Surgery Unit, Galeazzi – Sant’Ambrogio IRCCS Hospital, Insubria University, Varese, Italy
Abstract
Controversy persists regarding the ideal type of fixation for hernia mesh. Transfixing methods have been linked to tissue trauma and to the development of chronic pain. In ventral hernia repair (VHR), retrospective studies showed a potential for fixation with cyanoacrylate of being as effective as conventional suture or tacks methods but with less postoperative pain and complications. A pragmatic randomized trial was conducted on patients undergoing primary and incisional VHR, analyzing mesh fixation by cyanoacrylate (experimental group) versus sutures or reabsorbable tacks (control group), stratifying a priori by laparoscopic(LVHR) and open approach(OVHR) to account for distinct anatomical and biomechanical environments. Primary outcome was chronic postoperative pain. Secondary outcomes were postoperative complications, recurrence, operating time, intraoperative blood loss, pain during admission. Univariable and multivariable analysis were conducted. Two hundred fourteen patients were included, of which 109 treated laparoscopically. Overall chronic pain occurred exclusively within the open surgery cohort (12/105 cases, 11.4%), with no statistical difference between fixation arms. Cyanoacrylate for mesh fixation was independent factor for fewer perioperative complications (OR 0.457, 95% CI 0.244–0.855, p = 0.014), shorter operating time (− 7.172 min, 95%CI − 23.040/− 2.008, p = 0.02), reduced pain at hospital discharge (− 0.356 VAS point, 95%CI − 0.691/− 0.022, p = 0.037). In LVHR, non-transfixing mesh positioning was also a factor for less intraoperative blood loss. In OVHR there were no significant difference in outcomes between groups. In a pragmatic real-world setting, long-term chronic pain appears primarily driven by surgical access and wound-related factors rather than the independent effect of the mesh fixation method. Cyanoacrylate fixation provides significant perioperative advantages, particularly in LVHR.
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BibTeX
@article{prete2026multicentric,
title = {{Multicentric pragmatic randomized controlled trial of mesh fixation system in primary and recurrent ventral hernia repair}},
author = {Francesco Prete and Giuseppe Massimiliano De Luca and Francesco Vittore and Alessandro Pasculli and Luigi Marano and Giuseppe Carbotta and Giuseppe Cavallaro and Diego Cuccurullo and Lorenzo Fracasso and Stefania Romano and Giorgio Soliani and Carlo Sagnelli and Mariasole Fracasso and Riccardo Maglio and Silvia Malerba and Giuliana Rachele Puglisi and Alfio Gianalberto Testini and Michele Covelli and Angela Gurrado and Giampiero Campanelli and Mario Testini},
journal = {Updates in Surgery},
year = {2026},
month = sep,
doi = {10.1007/s13304-026-02817-1},
url = {https://doi.org/10.1007/s13304-026-02817-1},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Multicentric pragmatic randomized controlled trial of mesh fixation system in primary and recurrent ventral hernia repair
AU - Francesco Prete
AU - Giuseppe Massimiliano De Luca
AU - Francesco Vittore
AU - Alessandro Pasculli
AU - Luigi Marano
AU - Giuseppe Carbotta
AU - Giuseppe Cavallaro
AU - Diego Cuccurullo
AU - Lorenzo Fracasso
AU - Stefania Romano
AU - Giorgio Soliani
AU - Carlo Sagnelli
AU - Mariasole Fracasso
AU - Riccardo Maglio
AU - Silvia Malerba
AU - Giuliana Rachele Puglisi
AU - Alfio Gianalberto Testini
AU - Michele Covelli
AU - Angela Gurrado
AU - Giampiero Campanelli
AU - Mario Testini
PY - 2026
DA - 2026/09/07
JO - Updates in Surgery
DO - 10.1007/s13304-026-02817-1
UR - https://doi.org/10.1007/s13304-026-02817-1
AB - Controversy persists regarding the ideal type of fixation for hernia mesh. Transfixing methods have been linked to tissue trauma and to the development of chronic pain. In ventral hernia repair (VHR), retrospective studies showed a potential for fixation with cyanoacrylate of being as effective as conventional suture or tacks methods but with less postoperative pain and complications. A pragmatic randomized trial was conducted on patients undergoing primary and incisional VHR, analyzing mesh fixation by cyanoacrylate (experimental group) versus sutures or reabsorbable tacks (control group), stratifying a priori by laparoscopic(LVHR) and open approach(OVHR) to account for distinct anatomical and biomechanical environments. Primary outcome was chronic postoperative pain. Secondary outcomes were postoperative complications, recurrence, operating time, intraoperative blood loss, pain during admission. Univariable and multivariable analysis were conducted. Two hundred fourteen patients were included, of which 109 treated laparoscopically. Overall chronic pain occurred exclusively within the open surgery cohort (12/105 cases, 11.4%), with no statistical difference between fixation arms. Cyanoacrylate for mesh fixation was independent factor for fewer perioperative complications (OR 0.457, 95% CI 0.244–0.855, p = 0.014), shorter operating time (− 7.172 min, 95%CI − 23.040/− 2.008, p = 0.02), reduced pain at hospital discharge (− 0.356 VAS point, 95%CI − 0.691/− 0.022, p = 0.037). In LVHR, non-transfixing mesh positioning was also a factor for less intraoperative blood loss. In OVHR there were no significant difference in outcomes between groups. In a pragmatic real-world setting, long-term chronic pain appears primarily driven by surgical access and wound-related factors rather than the independent effect of the mesh fixation method. Cyanoacrylate fixation provides significant perioperative advantages, particularly in LVHR.
SN - 2038-131X
SN - 2038-3312
ER -