Laura Armañanzas1, Jaime Ruiz-Tovar2, Antonio Arroyo2, Pedro García-Peche3, Ernesto Armañanzas4, María Diez3, Isabel Galindo3, Rafael Calpena2. 1. Department of Surgery, General University Hospital Elche, Elche, Spain. Electronic address: laura.armananzas@gmail.com. 2. Department of Surgery, General University Hospital Elche, Elche, Spain; Department of Pathology and Surgery, School of Medicine, Miguel Hernandez University, Elche, Spain. 3. Department of Surgery, General University Hospital Elche, Elche, Spain. 4. Department of Surgery, Doctor Peset Hospital, Valencia, Spain.
Abstract
BACKGROUND: Prosthetic repair has become the standard method for hernia repair. Mesh placement for the prevention of trocar site incisional hernia (TSIH) is still a controversial issue. We tested the hypothesis that closure with an intraperitoneal prophylactic mesh of the umbilical trocar after a laparoscopic cholecystectomy can reduce the incidence of a TSIH in high-risk patients. STUDY DESIGN: A randomized clinical trial was conducted among patients undergoing elective laparoscopic cholecystectomy who presented the following high-risk factors for incisional hernia, according to the literature: age 65 years and older, diabetes mellitus, chronic pulmonary disease, and obesity (ie, body mass index ≥30 kg/m(2)). Patients were assigned to have closure of the umbilical trocar site with either nonabsorbable sutures (group A) or intraperitoneal polypropylene omega-3 mesh (group B). Trocar site incisional hernia, pain, and surgical complications were evaluated at the early postoperative course and at 1, 6, and 12 months after surgery. RESULTS:A total of 106 patients were randomized into the study and 92 patients were finally analyzed, including 47 in group A and 45 in group B. The TSIH rate was higher in group A (31.9%) than in group B (4.4%) (odds ratio = 10.1; 95% CI, 2.15-47.6; p < 0.001)). The wound infection rate was 4.3%; 8.5% in group A and 0% in group B (odds ratio = 2.04; 95% CI, 1.7-2.5; p = 0.045). Median postoperative pain evaluated by a visual analogue scale was 3 in group A and 2 in group B (p = 0.05). No differences were observed in complication rate, operative time, or hospital stay between the groups. CONCLUSIONS:Prosthetic closure of the umbilical trocar site after laparoscopic surgery could become the standard method for preventing TSIH in high-risk patients.
RCT Entities:
BACKGROUND: Prosthetic repair has become the standard method for hernia repair. Mesh placement for the prevention of trocar site incisional hernia (TSIH) is still a controversial issue. We tested the hypothesis that closure with an intraperitoneal prophylactic mesh of the umbilical trocar after a laparoscopic cholecystectomy can reduce the incidence of a TSIH in high-risk patients. STUDY DESIGN: A randomized clinical trial was conducted among patients undergoing elective laparoscopic cholecystectomy who presented the following high-risk factors for incisional hernia, according to the literature: age 65 years and older, diabetes mellitus, chronic pulmonary disease, and obesity (ie, body mass index ≥30 kg/m(2)). Patients were assigned to have closure of the umbilical trocar site with either nonabsorbable sutures (group A) or intraperitoneal polypropylene omega-3 mesh (group B). Trocar site incisional hernia, pain, and surgical complications were evaluated at the early postoperative course and at 1, 6, and 12 months after surgery. RESULTS: A total of 106 patients were randomized into the study and 92 patients were finally analyzed, including 47 in group A and 45 in group B. The TSIH rate was higher in group A (31.9%) than in group B (4.4%) (odds ratio = 10.1; 95% CI, 2.15-47.6; p < 0.001)). The wound infection rate was 4.3%; 8.5% in group A and 0% in group B (odds ratio = 2.04; 95% CI, 1.7-2.5; p = 0.045). Median postoperative pain evaluated by a visual analogue scale was 3 in group A and 2 in group B (p = 0.05). No differences were observed in complication rate, operative time, or hospital stay between the groups. CONCLUSIONS: Prosthetic closure of the umbilical trocar site after laparoscopic surgery could become the standard method for preventing TSIH in high-risk patients.
Authors: David Parés; Awad Shamali; Sam Stefan; Karen Flashman; Daniel O'Leary; John Conti; Asha Senapati; Amjad Parvaiz; Jim Khan Journal: Int J Colorectal Dis Date: 2016-06-02 Impact factor: 2.571
Authors: G Chatzimavroudis; B Papaziogas; I Galanis; I Koutelidakis; S Atmatzidis; P Evangelatos; N Voloudakis; A Ananiadis; A Doundis; E Christoforidis Journal: Hernia Date: 2017-10-25 Impact factor: 4.739