Reduction of adhesions after uterine myomectomy by Seprafilm membrane (HAL-F)

A blinded, prospective, randomized, multicenter clinical study

Michael Peter Diamond, E. Bieber, C. Coddington, R. Franklin, G. Grunert, D. Gunn, E. Lotze, G. Rowe, D. Grainger, B. Tjaden, G. Holtz, G. Patton, D. A. Johns, K. Johnson, M. Kettel, A. Morales, R. Leach, C. Blacker, J. M. Putman

Research output: Contribution to journalArticle

367 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)904-910
Number of pages7
JournalFertility and sterility
Volume66
Issue number6
StatePublished - Jan 1 1996

Fingerprint

Uterine Myomectomy
Multicenter Studies
Membranes
Incidence
Laparoscopy
Therapeutics
Videotape Recording
Seprafilm
Clinical Studies
Outcome Assessment (Health Care)
Safety

Keywords

  • HAL-F
  • Neoplasms, benign
  • Seprafilm
  • adhesions
  • laparotomy
  • leiomyomata uteri
  • surgery
  • uterus

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology

Cite this

Reduction of adhesions after uterine myomectomy by Seprafilm membrane (HAL-F) : A blinded, prospective, randomized, multicenter clinical study. / Diamond, Michael Peter; Bieber, E.; Coddington, C.; Franklin, R.; Grunert, G.; Gunn, D.; Lotze, E.; Rowe, G.; Grainger, D.; Tjaden, B.; Holtz, G.; Patton, G.; Johns, D. A.; Johnson, K.; Kettel, M.; Morales, A.; Leach, R.; Blacker, C.; Putman, J. M.

In: Fertility and sterility, Vol. 66, No. 6, 01.01.1996, p. 904-910.

Research output: Contribution to journalArticle

Diamond, MP, Bieber, E, Coddington, C, Franklin, R, Grunert, G, Gunn, D, Lotze, E, Rowe, G, Grainger, D, Tjaden, B, Holtz, G, Patton, G, Johns, DA, Johnson, K, Kettel, M, Morales, A, Leach, R, Blacker, C & Putman, JM 1996, 'Reduction of adhesions after uterine myomectomy by Seprafilm membrane (HAL-F): A blinded, prospective, randomized, multicenter clinical study', Fertility and sterility, vol. 66, no. 6, pp. 904-910.
Diamond, Michael Peter ; Bieber, E. ; Coddington, C. ; Franklin, R. ; Grunert, G. ; Gunn, D. ; Lotze, E. ; Rowe, G. ; Grainger, D. ; Tjaden, B. ; Holtz, G. ; Patton, G. ; Johns, D. A. ; Johnson, K. ; Kettel, M. ; Morales, A. ; Leach, R. ; Blacker, C. ; Putman, J. M. / Reduction of adhesions after uterine myomectomy by Seprafilm membrane (HAL-F) : A blinded, prospective, randomized, multicenter clinical study. In: Fertility and sterility. 1996 ; Vol. 66, No. 6. pp. 904-910.
@article{302c06a17a7a48438a0ef9a83aec1de9,
title = "Reduction of adhesions after uterine myomectomy by Seprafilm membrane (HAL-F): A blinded, prospective, randomized, multicenter clinical study",
abstract = "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.",
keywords = "HAL-F, Neoplasms, benign, Seprafilm, adhesions, laparotomy, leiomyomata uteri, surgery, uterus",
author = "Diamond, {Michael Peter} and E. Bieber and C. Coddington and R. Franklin and G. Grunert and D. Gunn and E. Lotze and G. Rowe and D. Grainger and B. Tjaden and G. Holtz and G. Patton and Johns, {D. A.} and K. Johnson and M. Kettel and A. Morales and R. Leach and C. Blacker and Putman, {J. M.}",
year = "1996",
month = "1",
day = "1",
language = "English (US)",
volume = "66",
pages = "904--910",
journal = "Fertility and Sterility",
issn = "0015-0282",
publisher = "Elsevier Inc.",
number = "6",

}

TY - JOUR

T1 - Reduction of adhesions after uterine myomectomy by Seprafilm membrane (HAL-F)

T2 - A blinded, prospective, randomized, multicenter clinical study

AU - Diamond, Michael Peter

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 - 1996/1/1

Y1 - 1996/1/1

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

M3 - Article

VL - 66

SP - 904

EP - 910

JO - Fertility and Sterility

JF - Fertility and Sterility

SN - 0015-0282

IS - 6

ER -