A prospective, controlled, randomized, multicenter, exploratory pilot study evaluating the safety and potential trends in efficacy of Adhexil

Michael Peter Diamond, Matthias Korell, Susana Martinez, Eran Kurman, Moshe Kamar, Michael Freeman, Dennis Chanter, David Wiseman, Sarah Horn

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

Objective: To present a multicenter, reviewer-blinded pilot study evaluating the safety and trends of efficacy of Adhexil, a novel product using fibrin sealant. Design: Randomized, reviewer-blinded assessment of postoperative adhesion development in women with bilateral ovarian disease. Setting: Gynecologic clinics. Patient(s): Women undergoing gynecologic surgery. Intervention(s): Patients were assessed for incidence, extent, and severity of ovarian adhesions at the first-look laparoscopy (1LL), followed by standard surgical procedure. Ovaries were randomized for application of Adhexil or untreated. A second-look laparoscopy (2LL) was performed to assess postoperative adhesions. Main Outcome Measure(s): Safety and efficacy of Adhexil. Result(s): A trend toward improvement in adhesion incidence was found in the treated ovaries, with 50% (8/16) of adhesion free ovaries in the Adhexil group, versus 31% (5/16) of control ovaries. Similarly, the improvement in the mean American Fertility Society (AFS) score in the Adhexil-treated group from 1LL (6.4 ± 6.8) to 2LL (4.6 ± 6.9) was observed, whereas worsening of adhesions was observed on the control side from 1LL (5.6 ± 5.1) to 2LL (7.1 ± 6.9). No adverse events or serious adverse events considered related to the study product were reported. Conclusion(s): A clear trend of efficacy for Adhexil reducing the incidence, severity, and extend of adhesions in laparoscopic gynecology surgery, despite the small sample size. The use of Adhexil appears safe. Further exploration of its safety and efficacy in preventing/reducing postsurgical adhesions is warranted.

Original languageEnglish (US)
Pages (from-to)1086-1090
Number of pages5
JournalFertility and Sterility
Volume95
Issue number3
DOIs
StatePublished - Mar 1 2011
Externally publishedYes

Fingerprint

Ovary
Laparoscopy
Safety
Incidence
Ovarian Diseases
Fibrin Tissue Adhesive
Gynecologic Surgical Procedures
Gynecology
Sample Size
Fertility
Outcome Assessment (Health Care)

Keywords

  • Adhexil
  • adhesion extent
  • adhesion incidence
  • adhesion severity
  • laparoscopic surgery

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology

Cite this

A prospective, controlled, randomized, multicenter, exploratory pilot study evaluating the safety and potential trends in efficacy of Adhexil. / Diamond, Michael Peter; Korell, Matthias; Martinez, Susana; Kurman, Eran; Kamar, Moshe; Freeman, Michael; Chanter, Dennis; Wiseman, David; Horn, Sarah.

In: Fertility and Sterility, Vol. 95, No. 3, 01.03.2011, p. 1086-1090.

Research output: Contribution to journalArticle

Diamond, Michael Peter ; Korell, Matthias ; Martinez, Susana ; Kurman, Eran ; Kamar, Moshe ; Freeman, Michael ; Chanter, Dennis ; Wiseman, David ; Horn, Sarah. / A prospective, controlled, randomized, multicenter, exploratory pilot study evaluating the safety and potential trends in efficacy of Adhexil. In: Fertility and Sterility. 2011 ; Vol. 95, No. 3. pp. 1086-1090.
@article{48e22b3c0dd04be0a2d610393b857061,
title = "A prospective, controlled, randomized, multicenter, exploratory pilot study evaluating the safety and potential trends in efficacy of Adhexil",
abstract = "Objective: To present a multicenter, reviewer-blinded pilot study evaluating the safety and trends of efficacy of Adhexil, a novel product using fibrin sealant. Design: Randomized, reviewer-blinded assessment of postoperative adhesion development in women with bilateral ovarian disease. Setting: Gynecologic clinics. Patient(s): Women undergoing gynecologic surgery. Intervention(s): Patients were assessed for incidence, extent, and severity of ovarian adhesions at the first-look laparoscopy (1LL), followed by standard surgical procedure. Ovaries were randomized for application of Adhexil or untreated. A second-look laparoscopy (2LL) was performed to assess postoperative adhesions. Main Outcome Measure(s): Safety and efficacy of Adhexil. Result(s): A trend toward improvement in adhesion incidence was found in the treated ovaries, with 50{\%} (8/16) of adhesion free ovaries in the Adhexil group, versus 31{\%} (5/16) of control ovaries. Similarly, the improvement in the mean American Fertility Society (AFS) score in the Adhexil-treated group from 1LL (6.4 ± 6.8) to 2LL (4.6 ± 6.9) was observed, whereas worsening of adhesions was observed on the control side from 1LL (5.6 ± 5.1) to 2LL (7.1 ± 6.9). No adverse events or serious adverse events considered related to the study product were reported. Conclusion(s): A clear trend of efficacy for Adhexil reducing the incidence, severity, and extend of adhesions in laparoscopic gynecology surgery, despite the small sample size. The use of Adhexil appears safe. Further exploration of its safety and efficacy in preventing/reducing postsurgical adhesions is warranted.",
keywords = "Adhexil, adhesion extent, adhesion incidence, adhesion severity, laparoscopic surgery",
author = "Diamond, {Michael Peter} and Matthias Korell and Susana Martinez and Eran Kurman and Moshe Kamar and Michael Freeman and Dennis Chanter and David Wiseman and Sarah Horn",
year = "2011",
month = "3",
day = "1",
doi = "10.1016/j.fertnstert.2010.11.024",
language = "English (US)",
volume = "95",
pages = "1086--1090",
journal = "Fertility and Sterility",
issn = "0015-0282",
publisher = "Elsevier Inc.",
number = "3",

}

TY - JOUR

T1 - A prospective, controlled, randomized, multicenter, exploratory pilot study evaluating the safety and potential trends in efficacy of Adhexil

AU - Diamond, Michael Peter

AU - Korell, Matthias

AU - Martinez, Susana

AU - Kurman, Eran

AU - Kamar, Moshe

AU - Freeman, Michael

AU - Chanter, Dennis

AU - Wiseman, David

AU - Horn, Sarah

PY - 2011/3/1

Y1 - 2011/3/1

N2 - Objective: To present a multicenter, reviewer-blinded pilot study evaluating the safety and trends of efficacy of Adhexil, a novel product using fibrin sealant. Design: Randomized, reviewer-blinded assessment of postoperative adhesion development in women with bilateral ovarian disease. Setting: Gynecologic clinics. Patient(s): Women undergoing gynecologic surgery. Intervention(s): Patients were assessed for incidence, extent, and severity of ovarian adhesions at the first-look laparoscopy (1LL), followed by standard surgical procedure. Ovaries were randomized for application of Adhexil or untreated. A second-look laparoscopy (2LL) was performed to assess postoperative adhesions. Main Outcome Measure(s): Safety and efficacy of Adhexil. Result(s): A trend toward improvement in adhesion incidence was found in the treated ovaries, with 50% (8/16) of adhesion free ovaries in the Adhexil group, versus 31% (5/16) of control ovaries. Similarly, the improvement in the mean American Fertility Society (AFS) score in the Adhexil-treated group from 1LL (6.4 ± 6.8) to 2LL (4.6 ± 6.9) was observed, whereas worsening of adhesions was observed on the control side from 1LL (5.6 ± 5.1) to 2LL (7.1 ± 6.9). No adverse events or serious adverse events considered related to the study product were reported. Conclusion(s): A clear trend of efficacy for Adhexil reducing the incidence, severity, and extend of adhesions in laparoscopic gynecology surgery, despite the small sample size. The use of Adhexil appears safe. Further exploration of its safety and efficacy in preventing/reducing postsurgical adhesions is warranted.

AB - Objective: To present a multicenter, reviewer-blinded pilot study evaluating the safety and trends of efficacy of Adhexil, a novel product using fibrin sealant. Design: Randomized, reviewer-blinded assessment of postoperative adhesion development in women with bilateral ovarian disease. Setting: Gynecologic clinics. Patient(s): Women undergoing gynecologic surgery. Intervention(s): Patients were assessed for incidence, extent, and severity of ovarian adhesions at the first-look laparoscopy (1LL), followed by standard surgical procedure. Ovaries were randomized for application of Adhexil or untreated. A second-look laparoscopy (2LL) was performed to assess postoperative adhesions. Main Outcome Measure(s): Safety and efficacy of Adhexil. Result(s): A trend toward improvement in adhesion incidence was found in the treated ovaries, with 50% (8/16) of adhesion free ovaries in the Adhexil group, versus 31% (5/16) of control ovaries. Similarly, the improvement in the mean American Fertility Society (AFS) score in the Adhexil-treated group from 1LL (6.4 ± 6.8) to 2LL (4.6 ± 6.9) was observed, whereas worsening of adhesions was observed on the control side from 1LL (5.6 ± 5.1) to 2LL (7.1 ± 6.9). No adverse events or serious adverse events considered related to the study product were reported. Conclusion(s): A clear trend of efficacy for Adhexil reducing the incidence, severity, and extend of adhesions in laparoscopic gynecology surgery, despite the small sample size. The use of Adhexil appears safe. Further exploration of its safety and efficacy in preventing/reducing postsurgical adhesions is warranted.

KW - Adhexil

KW - adhesion extent

KW - adhesion incidence

KW - adhesion severity

KW - laparoscopic surgery

UR - http://www.scopus.com/inward/record.url?scp=79951958758&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=79951958758&partnerID=8YFLogxK

U2 - 10.1016/j.fertnstert.2010.11.024

DO - 10.1016/j.fertnstert.2010.11.024

M3 - Article

C2 - 21193191

AN - SCOPUS:79951958758

VL - 95

SP - 1086

EP - 1090

JO - Fertility and Sterility

JF - Fertility and Sterility

SN - 0015-0282

IS - 3

ER -