Prevention of postoperative abdominal adhesions by a sodium hyaluronate-based bioresorbable membrane: a prospective, randomized, double-blind multicenter study.
BACKGROUND
Postoperative abdominal adhesions are associated with numerous complications, including small bowel obstruction, difficult and dangerous reoperations, and infertility. A sodium hyaluronate and carboxymethylcellulose bioresorbable membrane (HA membrane) was developed to reduce formation of postoperative adhesions. The objectives of our prospective study were to assess the incidence of adhesions that recurred after a standardized major abdominal operation using direct laparoscopic peritoneal imaging and to determine the safety and effectiveness of HA membrane in preventing postoperative adhesions.


METHODS
Eleven centers enrolled 183 patients with ulcerative colitis or familial polyposis who were scheduled for colectomy and ileal pouch-anal anastomosis with diverting-loop ileostomy. Before abdominal closure, patients were randomly assigned to receive or not receive HA membrane placed under the midline incision. At ileostomy closure eight to 12 weeks later, laparoscopy was used to evaluate the incidence, extent, and severity of adhesion formation to the midline incision.


RESULTS
Data were analyzed for 175 assessable patients. While only five (6 percent) of 90 control patients had no adhesions, 43 (51 percent) of 85 patients receiving HA membrane were free of adhesions (p < 0.00000000001). The mean percent of the incision length involved was 63 percent in the control group, significantly greater than the 23 percent observed in patients who received HA membrane (p < 0.001). Dense adhesions were observed in 52 (58 percent) of the 90 control patients, but in only 13 (15 percent) of the 85 receiving HA membrane (P < 0.0001). Comparison of the incidence of specific adverse events between the groups did not identify a difference (P > 0.05).


CONCLUSIONS
This study represents the first controlled, prospective evaluation of postoperative abdominal adhesion formation and prevention after general abdominal surgery using standardized, direct peritoneal visualization. In this study, HA membrane was safe and significantly reduced the incidence, extent, and severity of postoperative abdominal adhesions.
Becker
J M
JM
Boston University Medical Center Hospital, MA, USA.
Dayton
M T
MT
Fazio
V W
VW
Beck
D E
DE
Stryker
S J
SJ
Wexner
S D
SD
Wolff
B G
BG
Roberts
P L
PL
Smith
L E
LE
Sweeney
S A
SA
Moore
M
M
D011125:Adenomatous Polyposis Coli / Q000601:surgery; D000328:Adult; D001672:Biocompatible Materials; D002266:Carboxymethylcellulose Sodium; D003082:Colectomy; D003093:Colitis, Ulcerative / Q000601:surgery; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid; D007081:Ileostomy; D015994:Incidence; D008297:Male; D008567:Membranes, Artificial; D011183:Postoperative Complications / Q000453:epidemiology / Q000517:prevention & control*; D016737:Proctocolectomy, Restorative; D011446:Prospective Studies; D013997:Time Factors; D000267:Tissue Adhesions / Q000453:epidemiology / Q000517:prevention & control*
D001672:Biocompatible Materials; D008567:Membranes, Artificial; D006820:Hyaluronic Acid; D002266:Carboxymethylcellulose Sodium