Prospective clinical trial of SprayGel as a barrier to adhesion formation: an interim analysis

Abstract

Study objective: To evaluate SprayGel, a new sprayable adhesion barrier developed for laparoscopic and open pelvic and abdominal surgical procedures.

Design: Prospective, randomized, controlled, multicenter trial (Canadian Task Force classification I).

Setting: University clinic and private clinic.

Patients: Forty-five women, 24 randomized to treatment and 21 to control group.

Interventions: Open or laparoscopic myomectomy with and without application of SprayGel, followed by second-look laparoscopy (SLL) to evaluate postoperative adhesions.

Measurements and main results: Application of SprayGel was fast and easy. On average, 10 weeks after surgery, 18 treated patients (75%) and 13 (61.9%) controls had SLL. That procedure showed 5 (27.8%) of 18 treatment patients to be adhesion free versus 1 (7.7%) of 13 controls (p = 0.163). Patients randomized to SprayGel were 3.6 times more likely to be adhesion free than controls. Mean tenacity scores were significantly lower than in controls (0.5 vs. 1.7), a difference of 0.9 (95% CI 0.3, 1.5, p = 0.003) or 47% (95% CI 17%, 77%) less. Mean adhesion area was reduced in the treatment group (4.1 vs. 5.6) but not significant (p = 0.6747, 95% CI-5.4, 8.4). No adverse events regarding application of SprayGel were seen.

Conclusion: SprayGel was effective in reducing postoperative adhesion severity, and showed a trend toward reducing frequency and extent of adhesions after laparoscopic and open myomectomy. Further studies are necessary to confirm the promising results of this interim analysis.