TY - JOUR
T1 - Reduction of adhesions after uterine myomectomy by Seprafilm membrane (HAL-F)
T2 - A blinded, prospective, randomized, multicenter clinical study
AU - Diamond, M. P.
AU - Bieber, E.
AU - Coddington, C.
AU - Franklin, R.
AU - Grunert, G.
AU - Gunn, D.
AU - Lotze, E.
AU - Rowe, G.
AU - Grainger, D.
AU - Tjaden, B.
AU - Holtz, G.
AU - Patton, G.
AU - Johns, D. A.
AU - Johnson, K.
AU - Kettel, M.
AU - Morales, A.
AU - Leach, R.
AU - Blacker, C.
AU - Putman, J. M.
PY - 1996
Y1 - 1996
N2 - Objective: To assess the safety and efficacy of Seprafilm (HAL-F), Bioresorbable Membrane, (Genzyme Corporation, Cambridge, MA) in reducing the incidence, severity, extent, and area of uterine adhesions after myomectomy. Design: Prospective, randomized, blinded, multicenter study. Adhesion reduction was assessed by an independent, blinded, gynecologic surgeon who reviewed videotapes of each patient's second-look laparoscopy. Setting: Nineteen institutions across the United States. Patient(s): One hundred twenty-seven women undergoing uterine myomectomy with at least one posterior uterine incision ≤ 1 cm in length. Intervention(s): Patients were randomized to treatment with Seprafilm or to no treatment at the completion of the myomectomy. Main Outcome Measure(s): The incidence, severity, extent, and area of uterine adhesions at second-look laparoscopy. Result(s): The incidence, measured as the mean number of sites adherent to the uterine surface, was significantly less in treated patients (4.98 ± 0.52 [mean ± SEM] sites) than in no treatment patients (7.88 ± 0.48 sites) as were the mean uterine adhesion severity scores (1.94 ± 0.14 versus 2.43 ± 0.10; treatment versus no treatment, respectively), mean extent scores (1.23 ± 0.12 versus 1.68 ± 0.10), and mean area of adhesions (13.2 ± 1.67 versus 18.7 ± 1.66 cm2). No adverse events occurred that were judged to be related to the use of Seprafilm. Conclusion(s): In this multicenter study, treatment of patients after myomectomy with Seprafilm significantly reduced the incidence, severity, extent, and area of postoperative uterine adhesions. Additionally, Seprafilm treatment was not associated with an increase in postoperative complications.
AB - Objective: To assess the safety and efficacy of Seprafilm (HAL-F), Bioresorbable Membrane, (Genzyme Corporation, Cambridge, MA) in reducing the incidence, severity, extent, and area of uterine adhesions after myomectomy. Design: Prospective, randomized, blinded, multicenter study. Adhesion reduction was assessed by an independent, blinded, gynecologic surgeon who reviewed videotapes of each patient's second-look laparoscopy. Setting: Nineteen institutions across the United States. Patient(s): One hundred twenty-seven women undergoing uterine myomectomy with at least one posterior uterine incision ≤ 1 cm in length. Intervention(s): Patients were randomized to treatment with Seprafilm or to no treatment at the completion of the myomectomy. Main Outcome Measure(s): The incidence, severity, extent, and area of uterine adhesions at second-look laparoscopy. Result(s): The incidence, measured as the mean number of sites adherent to the uterine surface, was significantly less in treated patients (4.98 ± 0.52 [mean ± SEM] sites) than in no treatment patients (7.88 ± 0.48 sites) as were the mean uterine adhesion severity scores (1.94 ± 0.14 versus 2.43 ± 0.10; treatment versus no treatment, respectively), mean extent scores (1.23 ± 0.12 versus 1.68 ± 0.10), and mean area of adhesions (13.2 ± 1.67 versus 18.7 ± 1.66 cm2). No adverse events occurred that were judged to be related to the use of Seprafilm. Conclusion(s): In this multicenter study, treatment of patients after myomectomy with Seprafilm significantly reduced the incidence, severity, extent, and area of postoperative uterine adhesions. Additionally, Seprafilm treatment was not associated with an increase in postoperative complications.
KW - HAL-F
KW - Neoplasms, benign
KW - Seprafilm
KW - adhesions
KW - laparotomy
KW - leiomyomata uteri
KW - surgery
KW - uterus
UR - http://www.scopus.com/inward/record.url?scp=8044259000&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=8044259000&partnerID=8YFLogxK
U2 - 10.1016/s0015-0282(16)58716-0
DO - 10.1016/s0015-0282(16)58716-0
M3 - Article
C2 - 8941053
AN - SCOPUS:8044259000
SN - 0015-0282
VL - 66
SP - 904
EP - 910
JO - Fertility and sterility
JF - Fertility and sterility
IS - 6
ER -