Reproductive Surgery Adhesion Prevention
RRM Academy Synopsis
Interceed barrier reduced adhesion return after tubal microsurgery
About half of Interceed-covered organs stayed adhesion free, against under a third of uncovered ones. The randomized trial enrolled 66 women with tubal disease. Surgeons cut away adhesions through an open incision and placed Interceed on one side only. A camera check came 4 to 10 weeks later.
Key Findings
- At the repeat look, adhesion scores were lower than at the first operation on both the covered and uncovered sides (P < 0.01, paired t-test).
- Interceed enhanced the reduction in aggregate adhesion scores by 39% compared with microsurgery alone (P < 0.01). Site by site: ovaries 36%, fallopian tubes 39%, fimbriae 42%.
- Interceed plus microsurgery lowered adhesion scores by almost 70%, both in aggregate and at each individual site.
- Organs free of adhesions at second look, Interceed versus control: ovaries 47.0% versus 25.8%, fallopian tubes 50.0% versus 24.2%, fimbriae 57.6% versus 37.9%.
- Adhesions stayed away in 102 or 51.5% of 198 Interceed-covered organs and 58 or 29.3 of organs with surgery alone (P < 0.01). No side effects of Interceed were observed.
Interpretation
This randomized trial put Interceed on one side of each woman and left her other side as the surgical control. The surgeon did not know which side until placing the barrier. Microsurgery alone lowered adhesion scores from the first operation to the second look. Interceed lowered them further. Nearly twice as many organs stayed adhesion free with the barrier in place. The findings support larger studies of barrier use in fertility surgery.
RRM Context
Restorative Reproductive Medicine rebuilds the tube and ovary, then protects the repair as it heals. Adhesion prevention belongs to that work, because scar tissue that re-forms can undo the repair. Microsurgical technique alone lowered adhesion scores in this trial. The barrier added a further reduction.
Abstract
Objective
To evaluate the efficacy of Interceed as an adjuvant in the prevention of postoperative adhesion reformation to the ovary, fallopian tube, and fimbria when used together with microsurgical techniques.
Design
Prospective, randomized, multicenter, controlled clinical study.
Setting
Normal human volunteers in an academic research environment.
Patients
Sixty-six women suffering from infertility due at least in part to bilateral tubal disease with bilateral adhesions attached to ovaries, fallopian tubes, and fimbriae.
Intervention
Adhesiolysis bilaterly through laparotomy with microsurgical techniques, application of Interceed on one of the sides randomly assigned not known by the surgeon before application, follow-up laparoscopy 4 to 10 weeks postoperatively, with each patient serving as her own control.
Main Outcome Measures
Adhesion severity scores at all sites and number of adhesion free organs after laparotomy and follow-up laparoscopy.
Results
When the initial scores registered at the operation for fertility were compared with those registered at the second-look laparoscopy, the results indicated that gentle microsurgical techniques resulted in a significant reduction of postoperative adhesions. Adnexa, which were covered with Interceed, had significantly lower adhesion scores than the control adnexa, representing an improvement of 39% compared with microsurgery alone (control) in reducing adhesion reformation scores. When combined with microsurgical techniques, Interceed reduced adhesion reformation scores by 70%. The number of ovaries, fallopian tubes, and fimbriae without adhesions at the time of second-look laparoscopy was significantly increased by approximately twofold when organs were covered with Interceed.
Conclusion
In a prospective, randomized, multicenter, controlled clinical study using a protocol in which other adjuvants have been shown not to be efficacious, Interceed was shown to reduce significantly the incidence and severity of adhesion reformation to the ovary, fallopian tube, and fimbria after infertility surgery.
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Topics
Keywords
Cellulose, Oxidized/therapeutic Use, Fallopian Tube Diseases/pathology/prevention & Control, Female, Follow-Up Studies, Humans, Infertility, Female/drug Therapy/surgery, Laparoscopy, Laparotomy, Microsurgery, Ovarian Diseases/pathology/prevention & Control, Postoperative Complications/prevention & Control, Prospective Studies, Tissue Adhesions/pathology/prevention & Control, Cellulose, Oxidized, INTERCEED
