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

Abstract

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.

• Authors: Gere S diZerega, James Coad, Jacques Donnez
• Journal: Fertility and sterility (Fertil Steril) Vol. 87 Issue 3 Pg. 485-9 (Mar 2007) ISSN: 1556-5653 [Electronic] United States
• PMID: 17126335 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Gels
• Oxiplex
• Polyethylene Glycols
• Cellulose

Topics

• Cellulose (analogs & derivatives, therapeutic use)
• Color
• Double-Blind Method
• Endometriosis (surgery)
• Female
• Gels (therapeutic use)
• Gynecologic Surgical Procedures (adverse effects)
• Humans
• Laparoscopy (adverse effects)
• Polyethylene Glycols (therapeutic use)
• Tissue Adhesions (prevention & control)