Reduction of postsurgical adhesions with Intergel adhesion prevention solution: a multicenter study of safety and efficacy after conservative gynecologic surgery.
OBJECTIVE
To assess the safety and efficacy of the Intergel adhesion prevention solution, a 0.5% ferric hyaluronate gel, in reducing adhesions in patients undergoing peritoneal cavity surgery by laparotomy with a planned second-look laparoscopy.


METHODS
Randomized, third-party blinded, placebo-controlled, parallel group.


METHODS
Eleven centers in the United States, and five centers in Europe.


METHODS
Women aged 18-46 years who wanted to retain their fertility.


METHODS
Patients received 300 mL of Intergel solution (n = 143) or lactated Ringer's solution (n = 138) as an intraperitoneal instillate at the completion of surgery.


METHODS
At second-look laparoscopy 6-12 weeks later, the presence of adhesions was evaluated at 24 abdominal sites.


RESULTS
Patients treated with Intergel solution (n = 131) had significantly less adhesions compared to controls (n = 134). Adhesion extent and severity were also significantly reduced. The American Fertility Society score for adnexal adhesions was reduced 59% in the patients in whom the Intergel solution was used. The safety profile of the patients treated with the Intergel solution was comparable to those treated with lactated Ringer's solution.


CONCLUSIONS
The Intergel solution was safe and highly efficacious in reducing the number, severity, and extent of adhesions throughout the abdomen after peritoneal cavity surgery.
Johns
D B
DB
Keck School of Medicine, University of Southern California, Los Angeles 90033, USA.
Keyport
G M
GM
Hoehler
F
F
diZerega
G S
GS
D000293:Adolescent; D000328:Adult; D004715:Endometriosis / Q000601:surgery; D005060:Europe; D005260:Female; D013509:Gynecologic Surgical Procedures; D006801:Humans; D006820:Hyaluronic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D007552:Isotonic Solutions / Q000009:adverse effects / Q000627:therapeutic use; D010535:Laparoscopy; D008875:Middle Aged; D015588:Observer Variation; D010048:Ovarian Cysts / Q000601:surgery; D010919:Placebos; D011183:Postoperative Complications / Q000517:prevention & control*; D012086:Reoperation; D000077325:Ringer's Lactate; D012449:Safety; D016037:Single-Blind Method; D000267:Tissue Adhesions / Q000453:epidemiology / Q000517:prevention & control*; D014481:United States
D007552:Isotonic Solutions; D010919:Placebos; D000077325:Ringer's Lactate; D006820:Hyaluronic Acid