I Alarcón1,2, A Balla3,4, J R Soler Frías1, A Barranco1, J Bellido Luque2, S Morales-Conde1,2. 1. Unit of Innovation in Minimally Invasive Surgery, Department of General and Digestive Surgery, University Hospital "Virgen del Rocio", University of Sevilla, Sevilla, Spain. 2. Unit of General and Digestive Surgery, Hospital Quironsalud Sagrado Corazón, Sevilla, Spain. 3. Unit of Innovation in Minimally Invasive Surgery, Department of General and Digestive Surgery, University Hospital "Virgen del Rocio", University of Sevilla, Sevilla, Spain. andrea.balla@gmail.com. 4. Department of General Surgery and Surgical Specialties "Paride Stefanini", Sapienza, University of Rome, Viale del Policlinico 155, 00161, Rome, Italy. andrea.balla@gmail.com.
Abstract
PURPOSE: Aim of the study is to compare macroporous (> 1 mm2) polytetrafluoroethylene mesh (LP-PTFE) versus microporous (< 1 mm2) polypropylene mesh (SP-PPL) in terms of postoperative acute and chronic discomfort and pain, difficulty in mesh handling and long-term recurrence rate. METHODS:Fifty-two patients with bilateral hernia were enrolled in this double-blind randomized controlled trial (NCT02023203). Each hernia, in the same patient, was randomized to implant LP-PTFE or SP-PPL mesh during totally extraperitoneal laparoscopic hernia repair. Patients were followed at 7 days, 1, 3, 6, 12 and 60 months after surgery. Visual analog scale (VAS) score was employed to evaluate the outcomes. Student's t test was used in case of normally distributed continuous variables, while the nonparametric Mann-Whitney U test was used in case of not normally distributed variables. Chi square test was used for analysis of categorical variables. RESULTS:Median VAS discomfort score with SP-PPL was significantly higher than LP-PTFE at 1 and 3 months after surgery (p = 0.003 in both cases). LP-PTFE showed significantly lower median score than SP-PPL at 7 days after surgery (p = 0.025) regarding pain at movement. Testicular pain was lower in case of LP-PTFE than SP-PPL at 7 days, 1 and 3 months after surgery (p = 0.005, p = 0.004 and p = 0.004, respectively). LP-PTFE was significantly more difficult to handle (p = 0.001). At 60 months, one recurrence was observed in the LP-PTFE group (p = 1.0000). CONCLUSIONS:LP-PTFE has less postoperative discomfort and pain up to 3 months after surgery, without differences after that period, although it shows more difficulty in handling and recurrences occur even if not statistically significant.
RCT Entities:
PURPOSE: Aim of the study is to compare macroporous (> 1 mm2) polytetrafluoroethylene mesh (LP-PTFE) versus microporous (< 1 mm2) polypropylene mesh (SP-PPL) in terms of postoperative acute and chronic discomfort and pain, difficulty in mesh handling and long-term recurrence rate. METHODS: Fifty-two patients with bilateral hernia were enrolled in this double-blind randomized controlled trial (NCT02023203). Each hernia, in the same patient, was randomized to implant LP-PTFE or SP-PPL mesh during totally extraperitoneal laparoscopic hernia repair. Patients were followed at 7 days, 1, 3, 6, 12 and 60 months after surgery. Visual analog scale (VAS) score was employed to evaluate the outcomes. Student's t test was used in case of normally distributed continuous variables, while the nonparametric Mann-Whitney U test was used in case of not normally distributed variables. Chi square test was used for analysis of categorical variables. RESULTS: Median VAS discomfort score with SP-PPL was significantly higher than LP-PTFE at 1 and 3 months after surgery (p = 0.003 in both cases). LP-PTFE showed significantly lower median score than SP-PPL at 7 days after surgery (p = 0.025) regarding pain at movement. Testicular pain was lower in case of LP-PTFE than SP-PPL at 7 days, 1 and 3 months after surgery (p = 0.005, p = 0.004 and p = 0.004, respectively). LP-PTFE was significantly more difficult to handle (p = 0.001). At 60 months, one recurrence was observed in the LP-PTFE group (p = 1.0000). CONCLUSIONS:LP-PTFE has less postoperative discomfort and pain up to 3 months after surgery, without differences after that period, although it shows more difficulty in handling and recurrences occur even if not statistically significant.
Authors: A Sartori; A Balla; E Botteri; F Scolari; M Podda; P Lepiane; M Guerrieri; S Morales-Conde; A Szold; M Ortenzi Journal: Hernia Date: 2022-05-26 Impact factor: 4.739