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JOURNAL ARTICLE
RESEARCH SUPPORT, NON-U.S. GOV'T
Two-year patient-related outcome measures (PROM) of primary ventral and incisional hernia repair using a novel three-dimensional composite polyester monofilament mesh: the SymCHro registry study.
PURPOSE: This study examined patient-related outcome measures (PROMs) after repair of ventral primary or incisional hernias using Symbotex™ composite mesh (SCM), a novel three-dimensional collagen-coated monofilament polyester textile.
METHODS: Pre-operative, peri-operative, and post-operative data were obtained from the French "Club Hernie" registry with 12- and 24-month follow-up.
RESULTS: One-hundred consecutive patients (mean age 62.0 ± 13.7; 51% female) underwent repair of 105 hernias: primary (39/105, 37.1%, defect area 5.2 ± 5.6 cm2 ) and incisional (66/105, 62.9%, 31.9 ± 38.7.8 cm2 ). The mean BMI was 29.7 (± 5.6 kg/m2 ). American Society of Anesthesiologists classifications were I 39.4%, II 37.4% and III 23.2%. 75% had risk factors for healing and/or dissection. Of 38 primary repairs, 37 were completed laparoscopically (combined approach n = 1), and of 62 incisional hernia repairs, 40 were completed laparoscopically, and 20 by open repair (combined approach n = 2). Laparoscopic was quicker than open repair (36.2 ± 23.5 min vs. 67.4 ± 25.8, p < 0001). Before surgery, 86.3% of hernias were reported to cause discomfort/pain or dysesthesia. At 24 months (93 of 100 patients), 91 (97.8%) reported no lump and 81 (87.1%) no pain or discomfort. Of 91 patients, 86 (94.5%) rated their repair "good" or "excellent." There were nine non-serious, surgeon-detected adverse events (ileus, n = 3; seroma, n = 6) and one hernia recurrence (6-12 months).
CONCLUSIONS: Compared to baseline, open and laparoscopic surgery improved PROMs 24 months after primary and incisional hernia repair. Minimal complications and recurrence support the long-term efficacy of SCM.
METHODS: Pre-operative, peri-operative, and post-operative data were obtained from the French "Club Hernie" registry with 12- and 24-month follow-up.
RESULTS: One-hundred consecutive patients (mean age 62.0 ± 13.7; 51% female) underwent repair of 105 hernias: primary (39/105, 37.1%, defect area 5.2 ± 5.6 cm2 ) and incisional (66/105, 62.9%, 31.9 ± 38.7.8 cm2 ). The mean BMI was 29.7 (± 5.6 kg/m2 ). American Society of Anesthesiologists classifications were I 39.4%, II 37.4% and III 23.2%. 75% had risk factors for healing and/or dissection. Of 38 primary repairs, 37 were completed laparoscopically (combined approach n = 1), and of 62 incisional hernia repairs, 40 were completed laparoscopically, and 20 by open repair (combined approach n = 2). Laparoscopic was quicker than open repair (36.2 ± 23.5 min vs. 67.4 ± 25.8, p < 0001). Before surgery, 86.3% of hernias were reported to cause discomfort/pain or dysesthesia. At 24 months (93 of 100 patients), 91 (97.8%) reported no lump and 81 (87.1%) no pain or discomfort. Of 91 patients, 86 (94.5%) rated their repair "good" or "excellent." There were nine non-serious, surgeon-detected adverse events (ileus, n = 3; seroma, n = 6) and one hernia recurrence (6-12 months).
CONCLUSIONS: Compared to baseline, open and laparoscopic surgery improved PROMs 24 months after primary and incisional hernia repair. Minimal complications and recurrence support the long-term efficacy of SCM.
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