title: Prophylactic mesh vs suture in the closure of the umbilical trocar site after laparoscopic cholecystectomy in high-risk patients for incisional hernia. A randomized clinical trial.
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.
  
  
  METHODS
  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.affiliation: Department of Surgery, General University Hospital Elche, Elche, Spain. Electronic address: laura.armananzas@gmail.com.
authors.forename: Laura
authors.initials: L
authors.lastname: Armañanzas
authors.affiliation: Department of Surgery, General University Hospital Elche, Elche, Spain; Department of Pathology and Surgery, School of Medicine, Miguel Hernandez University, Elche, Spain.
authors.forename: Jaime
authors.initials: J
authors.lastname: Ruiz-Tovar
authors.affiliation: Department of Surgery, General University Hospital Elche, Elche, Spain; Department of Pathology and Surgery, School of Medicine, Miguel Hernandez University, Elche, Spain.
authors.forename: Antonio
authors.initials: A
authors.lastname: Arroyo
authors.affiliation: Department of Surgery, General University Hospital Elche, Elche, Spain.
authors.forename: Pedro
authors.initials: P
authors.lastname: García-Peche
authors.affiliation: Department of Surgery, Doctor Peset Hospital, Valencia, Spain.
authors.forename: Ernesto
authors.initials: E
authors.lastname: Armañanzas
authors.affiliation: Department of Surgery, General University Hospital Elche, Elche, Spain.
authors.forename: María
authors.initials: M
authors.lastname: Diez
authors.affiliation: Department of Surgery, General University Hospital Elche, Elche, Spain.
authors.forename: Isabel
authors.initials: I
authors.lastname: Galindo
authors.affiliation: Department of Surgery, General University Hospital Elche, Elche, Spain; Department of Pathology and Surgery, School of Medicine, Miguel Hernandez University, Elche, Spain.
authors.forename: Rafael
authors.initials: R
authors.lastname: Calpena
mesh_terms: D000368:Aged; D017081:Cholecystectomy, Laparoscopic / Q000009:adverse effects / Q000379:methods*; D002769:Cholelithiasis / Q000601:surgery*; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D046449:Hernia, Abdominal / Q000209:etiology / Q000517:prevention & control*; D006801:Humans; D020706:Laparoscopes; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000517:prevention & control; D011446:Prospective Studies; D012307:Risk Factors; D013526:Surgical Mesh; D013536:Suture Techniques / Q000295:instrumentation*; D014472:Umbilicus / Q000601:surgery*