Cross-Linked Chondroitin Sulfate Adhesion Barrier System in Open Rectal Resection: A Randomized Clinical Trial.
Yukihide Kanemitsu, Eiji Hashizume, Takeshi Suto et al.
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In 30 seconds
This multicenter, prospective, randomized, open-label trial with blinded endpoint assessment evaluated powdered cross-linked chondroitin sulfate (SI-449) in adults undergoing open rectal resection for rectal cancer. At 53 Japanese hospitals, 118 patients who underwent follow-up ileostomy closure were included in the modified intention-to-treat analysis. Adhesions beneath the incision were observed in 26 of 58 patients (45%) given SI-449 and 56 of 60 controls (93%) (P < .001). Adhesion severity and extent were also significantly reduced; the investigators reported good operability and no safety concerns.
Key findings
- Incisional adhesion incidence was 45% with SI-449 (26 of 58) versus 93% in controls (56 of 60; P < .001).
- Adhesion severity and extent were significantly lower in the SI-449 group.
- The trial reported good operability and no safety concerns.
Why it matters
Postoperative adhesions can contribute to intestinal obstruction, infertility, and pelvic pain. This randomized trial found substantially fewer adhesions at the incision site with SI-449 in open rectal resection, alongside reduced severity and extent. The findings support further consideration of this barrier as an option for adhesion prevention in the studied surgical setting, while not establishing effects on later adhesion-related clinical complications.
What to keep in mind
The study assessed adhesions at follow-up ileostomy closure; the abstract does not report whether SI-449 reduced subsequent adhesion-related symptoms or complications.