Sanne Harsløf1, Pia Krum-Møller2, Thorbjørn Sommer3, Nellie Zinther2, Pål Wara4, Hans Friis-Andersen2. 1. Department of Surgery, Regional Hospital Horsens, Sundvej 30, 8700, Horsens, Denmark. sanneharslof@gmail.dk. 2. Department of Surgery, Regional Hospital Horsens, Sundvej 30, 8700, Horsens, Denmark. 3. Department of Surgery, Randers, Denmark. 4. Department of Surgery, Aarhus University Hospital, Aarhus, Denmark.
Abstract
PURPOSE: The method of anchoring the mesh in laparoscopic ventral hernia repair is claimed to cause postoperative pain, affecting the quality of life of the patients. The aim of this randomized study was to compare the effect of three types of fixation devices on postoperative pain, patient quality of life, and hernia recurrence. METHODS:Patients with ventral hernias between 2 and 7 cm were randomized into one of three mesh fixation groups: permanent tacks (Protack™), absorbable tacks (Securestrap™), and absorbable synthetic glue (Glubran™). The primary endpoint was pain on the second postoperative day, measured on a visual analogue scale. Quality of life and recurrence rate were secondary endpoints and investigated through questionnaires and clinical examination at follow-up visits 1, 6, and 12 months after surgery. RESULTS:Seventy-five non-consecutive patients were included in the study, with 25 patients in each group. There was no significant difference between groups for unspecified pain on the second postoperative day (p = 0.250). The DoloTest™ values were 55.3 ± 28.9 mm, 43.5 ± 28.5 mm, and 55.9 ± 26.3 mm for permanent tacks, absorbable tacks, and synthetic glue, respectively. No differences were observed between groups with respect to quality of life of the patients and hernia recurrence rate. CONCLUSIONS: In patients with small- and medium-sized ventral hernias, the type of fixation device did not affect the immediate or long-term postoperative pain, quality of life, or recurrence rate when comparing permanent tacks, absorbable tacks, and synthetic glue for mesh fixation. TRIAL REGISTRATION: NCT01534780.
RCT Entities:
PURPOSE: The method of anchoring the mesh in laparoscopic ventral hernia repair is claimed to cause postoperative pain, affecting the quality of life of the patients. The aim of this randomized study was to compare the effect of three types of fixation devices on postoperative pain, patient quality of life, and hernia recurrence. METHODS:Patients with ventral hernias between 2 and 7 cm were randomized into one of three mesh fixation groups: permanent tacks (Protack™), absorbable tacks (Securestrap™), and absorbable synthetic glue (Glubran™). The primary endpoint was pain on the second postoperative day, measured on a visual analogue scale. Quality of life and recurrence rate were secondary endpoints and investigated through questionnaires and clinical examination at follow-up visits 1, 6, and 12 months after surgery. RESULTS: Seventy-five non-consecutive patients were included in the study, with 25 patients in each group. There was no significant difference between groups for unspecifiedpain on the second postoperative day (p = 0.250). The DoloTest™ values were 55.3 ± 28.9 mm, 43.5 ± 28.5 mm, and 55.9 ± 26.3 mm for permanent tacks, absorbable tacks, and synthetic glue, respectively. No differences were observed between groups with respect to quality of life of the patients and hernia recurrence rate. CONCLUSIONS: In patients with small- and medium-sized ventral hernias, the type of fixation device did not affect the immediate or long-term postoperative pain, quality of life, or recurrence rate when comparing permanent tacks, absorbable tacks, and synthetic glue for mesh fixation. TRIAL REGISTRATION: NCT01534780.
Entities:
Keywords:
Pain; Quality of life; Recurrence; Ventral hernia
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