Reduction of postoperative adhesion formation after laparoscopic ovarian cystectomy.
The purpose of this randomized, open-label study was to assess the efficacy of the product Interceed absorbable adhesion barrier in the prevention of adhesion formation on the ovary after laparoscopic ovarian cystectomy. A total of 25 patients requiring laparoscopic bilateral ovarian cystectomy were enrolled into this study. After removal of ovarian cysts, peri-adnexal adhesions, and peritoneal irrigants, and the attainment of meticulous haemostasis, the random assignment of one ovary for wrapping with Interceed was revealed to the surgeon. The other ovary served as the untreated control. A follow-up laparoscopy was performed 8-30 weeks after the initial procedure in 17 patients. Significantly fewer adhesions formed at the Interceed treated ovaries compared with the control (untreated) ovaries (P < 0.05). In terms of adhesion-free outcome, 76% (13/17) of Interceed treated ovaries and 35% (6/17) of control ovaries were free of adhesions. A significant reduction was observed in the area of the sutured ovaries involved with adhesions when Interceed (6%) was used, compared with controls (20%). The reduction of adhesion formation was not related to the size of the cysts at the initial procedure. No adverse events were reported by any patient during the study. In conclusion, Interceed was found to be safe and effective in reducing the incidence of postoperative adhesion formation in patients undergoing laparoscopic ovarian cystectomy.
Keckstein
J
J
Centre for Minimally Invasive Surgery, Dr Krüsmann Clinic for Women, Munich, Germany.
Ulrich
U
U
Sasse
V
V
Roth
A
A
Tuttlies
F
F
Karageorgieva
E
E
D002483:Cellulose, Oxidized / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D010535:Laparoscopy / Q000009:adverse effects; D010048:Ovarian Cysts / Q000601:surgery*; D011183:Postoperative Complications / Q000517:prevention & control*; D012449:Safety; D013997:Time Factors; D000267:Tissue Adhesions / Q000517:prevention & control*
D002483:Cellulose, Oxidized; C060002:INTERCEED