D E Beck1. 1. Department of Colorectal Surgery, Ochsner Clinic, New Orleans, LA, USA.
Abstract
OBJECTIVE: To evaluate, the safety and efficacy of Seprafilm, a novel bioresorbable membrane of chemically modified hyaluronic acid and carboxymethylcellulose, in preventing and reducing postoperative adhesion formation. DESIGN: Randomized, controlled, blinded, prospective multicenter study. SETTING:Major academic surgical centers. SUBJECTS: 183 (treatment, n = 91; control, n = 92) patients with ulcerative colitis or familial polyposis. INTERVENTIONS:Restorative proctocolectomy and ileal J-pouch anastomosis with diverting ileostomy followed by second-stage laparoscopy for ileostomy closure and direct visual assessment of the peritoneal cavity. Before abdominal closure in treated patients, Seprafilm, averaging 406.9 cm2 per patient, was applied without suturing between the midline incision and underlying tissues and organs. MAIN OUTCOME MEASURES: Determination of the incidence, extent (mean percentage of midline incision associated with adhesions), severity (grade 1, least severe; grade 2, moderately severe; grade 3, very severe), and distribution of adhesions. RESULTS: In 175 (treatment, n = 90) evaluable patients, Seprafilm significantly reduced the incidence (49% and 94%, respectively, p < 0.0001), extent (23% and 63%, respectively, p < 0.0001), and severity (15% versus 58% grade 3 severity, respectively, p < 0.0001) of postoperative adhesions. Seprafilm decreased the rate of adhesion formation by nearly 50%. More than half (51%) of Seprafilm recipients were adhesion-free, versus only 6% of untreated patients. Thus treated patients were eight times more likely to be free of adhesions than untreated controls. The incidence of incisional adhesions associated with the omentum, small bowel, left sidewall, bladder, ileostomy, and stomach was significantly reduced in the Seprafilm patients. Effects on vital signs and laboratory parameters were comparable in the two groups and were attributable to the operative procedure, concomitant therapy, or comorbid disease. All reported adverse events were associated with the surgical procedure and/or comorbid disease and did not differ significantly between the two groups (p > 0.05). CONCLUSION:Seprafilm is safe and significantly reduces the incidence, extent, and severity of postoperative adhesions to the midline incision compared with no treatment, the current standard of surgical care.
RCT Entities:
OBJECTIVE: To evaluate, the safety and efficacy of Seprafilm, a novel bioresorbable membrane of chemically modified hyaluronic acid and carboxymethylcellulose, in preventing and reducing postoperative adhesion formation. DESIGN: Randomized, controlled, blinded, prospective multicenter study. SETTING: Major academic surgical centers. SUBJECTS: 183 (treatment, n = 91; control, n = 92) patients with ulcerative colitis or familial polyposis. INTERVENTIONS: Restorative proctocolectomy and ileal J-pouch anastomosis with diverting ileostomy followed by second-stage laparoscopy for ileostomy closure and direct visual assessment of the peritoneal cavity. Before abdominal closure in treated patients, Seprafilm, averaging 406.9 cm2 per patient, was applied without suturing between the midline incision and underlying tissues and organs. MAIN OUTCOME MEASURES: Determination of the incidence, extent (mean percentage of midline incision associated with adhesions), severity (grade 1, least severe; grade 2, moderately severe; grade 3, very severe), and distribution of adhesions. RESULTS: In 175 (treatment, n = 90) evaluable patients, Seprafilm significantly reduced the incidence (49% and 94%, respectively, p < 0.0001), extent (23% and 63%, respectively, p < 0.0001), and severity (15% versus 58% grade 3 severity, respectively, p < 0.0001) of postoperative adhesions. Seprafilm decreased the rate of adhesion formation by nearly 50%. More than half (51%) of Seprafilm recipients were adhesion-free, versus only 6% of untreated patients. Thus treated patients were eight times more likely to be free of adhesions than untreated controls. The incidence of incisional adhesions associated with the omentum, small bowel, left sidewall, bladder, ileostomy, and stomach was significantly reduced in the Seprafilmpatients. Effects on vital signs and laboratory parameters were comparable in the two groups and were attributable to the operative procedure, concomitant therapy, or comorbid disease. All reported adverse events were associated with the surgical procedure and/or comorbid disease and did not differ significantly between the two groups (p > 0.05). CONCLUSION:Seprafilm is safe and significantly reduces the incidence, extent, and severity of postoperative adhesions to the midline incision compared with no treatment, the current standard of surgical care.
Authors: Mehmet Kamil Yildiz; Ismail Okan; Nevra Dursun; Gurhan Bas; Orhan Alimoglu; Bulent Kaya; Mehmet Odabasi; Mustafa Sahin Journal: Int J Clin Exp Med Date: 2014-02-15