Clinical evaluation of endometriosis and differential response to surgical therapy with and without application of Oxiplex/AP adhesion barrier gel

Objective To correlate parameters of endometriosis obtained during routine clinical evaluation with the subsequent formation of adhesions following surgical treatment by laparoscopy. Design Randomized, controlled, double-blind, clinical trial. Setting Tertiary referral centers for the treatment of e...

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Veröffentlicht in:Fertility and sterility 2007-03, Vol.87 (3), p.485-489
Hauptverfasser: diZerega, Gere S., M.D, Coad, James, M.D, Donnez, Jacques, M.D
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creator diZerega, Gere S., M.D
Coad, James, M.D
Donnez, Jacques, M.D
description Objective To correlate parameters of endometriosis obtained during routine clinical evaluation with the subsequent formation of adhesions following surgical treatment by laparoscopy. Design Randomized, controlled, double-blind, clinical trial. Setting Tertiary referral centers for the treatment of endometriosis. Patient(s) Thirty-seven patients (65 with adnexa) with stage I–III endometriosis; endometrioma-only patients were excluded. Intervention Laparoscopic surgical treatment of endometriosis, followed by randomization to Oxiplex/AP (FzioMed, Inc., San Luis Obispo, California) gel treatment (treated group) of adnexa, or surgery alone (control group); follow-up laparoscopy 6–10 weeks later. Main Outcome Measure(s) Adnexal Americn Fertility Society score, correlated with color and location of endometriosis, as well as stage of disease determined by masked review of videotapes. Result(s) Control patients with at least 50% red lesions had a greater increase in ipsilateral adnexal adhesion scores than patients with mostly black or white and/or clear lesions. Treated patients with red lesions had a greater decrease in adnexal adhesion scores than control patients. There was a correlation between baseline endometriosis stage and postoperative adhesion formation in control patients, but not treated patients. Conclusion(s) Patients with red endometriotic lesions had greater increases in their adhesion scores than patients with only black, white, and/or clear lesions. Oxiplex/AP gel was effective in reducing adhesions, compared to surgery alone, in all groups.
doi_str_mv 10.1016/j.fertnstert.2006.07.1505
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Design Randomized, controlled, double-blind, clinical trial. Setting Tertiary referral centers for the treatment of endometriosis. Patient(s) Thirty-seven patients (65 with adnexa) with stage I–III endometriosis; endometrioma-only patients were excluded. Intervention Laparoscopic surgical treatment of endometriosis, followed by randomization to Oxiplex/AP (FzioMed, Inc., San Luis Obispo, California) gel treatment (treated group) of adnexa, or surgery alone (control group); follow-up laparoscopy 6–10 weeks later. Main Outcome Measure(s) Adnexal Americn Fertility Society score, correlated with color and location of endometriosis, as well as stage of disease determined by masked review of videotapes. Result(s) Control patients with at least 50% red lesions had a greater increase in ipsilateral adnexal adhesion scores than patients with mostly black or white and/or clear lesions. Treated patients with red lesions had a greater decrease in adnexal adhesion scores than control patients. There was a correlation between baseline endometriosis stage and postoperative adhesion formation in control patients, but not treated patients. Conclusion(s) Patients with red endometriotic lesions had greater increases in their adhesion scores than patients with only black, white, and/or clear lesions. Oxiplex/AP gel was effective in reducing adhesions, compared to surgery alone, in all groups.</description><identifier>ISSN: 0015-0282</identifier><identifier>EISSN: 1556-5653</identifier><identifier>DOI: 10.1016/j.fertnstert.2006.07.1505</identifier><identifier>PMID: 17126335</identifier><identifier>CODEN: FESTAS</identifier><language>eng</language><publisher>New York, NY: Elsevier Inc</publisher><subject>Adhesion prevention ; Biological and medical sciences ; Cellulose - analogs &amp; derivatives ; Cellulose - therapeutic use ; Color ; Double-Blind Method ; endometriosis ; Endometriosis - surgery ; Female ; Female genital diseases ; Gels - therapeutic use ; Gynecologic Surgical Procedures - adverse effects ; Gynecology. Andrology. 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Obstetrics</topic><topic>Humans</topic><topic>Internal Medicine</topic><topic>Laparoscopy - adverse effects</topic><topic>Medical sciences</topic><topic>Non tumoral diseases</topic><topic>Obstetrics and Gynecology</topic><topic>Oxiplex/AP gel</topic><topic>Polyethylene Glycols - therapeutic use</topic><topic>Tissue Adhesions - prevention &amp; control</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>diZerega, Gere S., M.D</creatorcontrib><creatorcontrib>Coad, James, M.D</creatorcontrib><creatorcontrib>Donnez, Jacques, M.D</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Fertility and sterility</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>diZerega, Gere S., M.D</au><au>Coad, James, M.D</au><au>Donnez, Jacques, M.D</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Clinical evaluation of endometriosis and differential response to surgical therapy with and without application of Oxiplex/AP adhesion barrier gel</atitle><jtitle>Fertility and sterility</jtitle><addtitle>Fertil Steril</addtitle><date>2007-03-01</date><risdate>2007</risdate><volume>87</volume><issue>3</issue><spage>485</spage><epage>489</epage><pages>485-489</pages><issn>0015-0282</issn><eissn>1556-5653</eissn><coden>FESTAS</coden><abstract>Objective To correlate parameters of endometriosis obtained during routine clinical evaluation with the subsequent formation of adhesions following surgical treatment by laparoscopy. 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subjects Adhesion prevention
Biological and medical sciences
Cellulose - analogs & derivatives
Cellulose - therapeutic use
Color
Double-Blind Method
endometriosis
Endometriosis - surgery
Female
Female genital diseases
Gels - therapeutic use
Gynecologic Surgical Procedures - adverse effects
Gynecology. Andrology. Obstetrics
Humans
Internal Medicine
Laparoscopy - adverse effects
Medical sciences
Non tumoral diseases
Obstetrics and Gynecology
Oxiplex/AP gel
Polyethylene Glycols - therapeutic use
Tissue Adhesions - prevention & control
title Clinical evaluation of endometriosis and differential response to surgical therapy with and without application of Oxiplex/AP adhesion barrier gel
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