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Intercoat (Oxiplex/AP gel) for preventing intrauterine adhesions after operative hysteroscopy for suspected retained products of conception: double-blind, prospective, randomized pilot study.
J Minim Invasive Gynecol. 2014 Jan-Feb; 21(1):126-30.JM

Abstract

STUDY OBJECTIVE

To evaluate the safety and effectiveness of Oxiplex/AP gel (Intercoat) in reducing intrauterine adhesion formation after hysteroscopic treatment because of retained products of conception (RPOC).

DESIGN

Prospective double-blind, randomized, controlled pilot study (Canadian Task Force classification I).

SETTING

Tertiary medical center.

PATIENTS

All women who underwent hysteroscopic treatment because of RPOC at our institution between September 2009 and June 2012 were invited to participate. After operative hysteroscopy, participants were randomized to either have their uterine cavity filled with Oxiplex/AP gel (study group, n = 26) or not (control group, n = 26).

INTERVENTIONS

Diagnostic office hysteroscopy to assess for adhesion formation was performed after 6 to 8 weeks. Findings were graded according to the American Fertility Society classification. Rates of subsequent pregnancy in the 2 groups were assessed.

MEASUREMENTS AND MAIN RESULTS

Intraoperative complication rates were similar between the 2 groups. There were no postoperative complications after Oxiplex/AP gel application. Moderate to severe adhesions developed in 1 woman (4%) in the study group and 3 (14%) in the control group (p = .80). During follow-up of 20 months (range, 2-33 months), 7 women (27%) in the treatment group conceived, compared with 3 (14%) in the control group (p = .50).

CONCLUSION

Intrauterine application of Oxiplex/AP gel after hysteroscopic removal of RPOC is safe. In this small sample, the difference in the rate of intrauterine adhesions was not statistically significant. A larger study would enable further establishment of the safety and efficacy of use of this gel.

Authors+Show Affiliations

Department of Obstetrics and Gynecology, Assaf Harofe Medical Center, Tel-Aviv University, Tel-Aviv, Israel. Electronic address: Noga_fuchs@yahoo.com.Department of Obstetrics and Gynecology, Assaf Harofe Medical Center, Tel-Aviv University, Tel-Aviv, Israel.Department of Obstetrics and Gynecology, Assaf Harofe Medical Center, Tel-Aviv University, Tel-Aviv, Israel.Department of Obstetrics and Gynecology, Assaf Harofe Medical Center, Tel-Aviv University, Tel-Aviv, Israel.Department of Obstetrics and Gynecology, Assaf Harofe Medical Center, Tel-Aviv University, Tel-Aviv, Israel.Department of Obstetrics and Gynecology, Assaf Harofe Medical Center, Tel-Aviv University, Tel-Aviv, Israel.Department of Obstetrics and Gynecology, Assaf Harofe Medical Center, Tel-Aviv University, Tel-Aviv, Israel.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

23954387

Citation

Fuchs, Noga, et al. "Intercoat (Oxiplex/AP Gel) for Preventing Intrauterine Adhesions After Operative Hysteroscopy for Suspected Retained Products of Conception: Double-blind, Prospective, Randomized Pilot Study." Journal of Minimally Invasive Gynecology, vol. 21, no. 1, 2014, pp. 126-30.
Fuchs N, Smorgick N, Ben Ami I, et al. Intercoat (Oxiplex/AP gel) for preventing intrauterine adhesions after operative hysteroscopy for suspected retained products of conception: double-blind, prospective, randomized pilot study. J Minim Invasive Gynecol. 2014;21(1):126-30.
Fuchs, N., Smorgick, N., Ben Ami, I., Vaknin, Z., Tovbin, Y., Halperin, R., & Pansky, M. (2014). Intercoat (Oxiplex/AP gel) for preventing intrauterine adhesions after operative hysteroscopy for suspected retained products of conception: double-blind, prospective, randomized pilot study. Journal of Minimally Invasive Gynecology, 21(1), 126-30. https://doi.org/10.1016/j.jmig.2013.07.019
Fuchs N, et al. Intercoat (Oxiplex/AP Gel) for Preventing Intrauterine Adhesions After Operative Hysteroscopy for Suspected Retained Products of Conception: Double-blind, Prospective, Randomized Pilot Study. J Minim Invasive Gynecol. 2014 Jan-Feb;21(1):126-30. PubMed PMID: 23954387.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Intercoat (Oxiplex/AP gel) for preventing intrauterine adhesions after operative hysteroscopy for suspected retained products of conception: double-blind, prospective, randomized pilot study. AU - Fuchs,Noga, AU - Smorgick,Noam, AU - Ben Ami,Ido, AU - Vaknin,Zvi, AU - Tovbin,Yoseph, AU - Halperin,Reuvit, AU - Pansky,Moty, Y1 - 2013/08/14/ PY - 2013/06/07/received PY - 2013/07/29/revised PY - 2013/07/30/accepted PY - 2013/8/20/entrez PY - 2013/8/21/pubmed PY - 2014/8/21/medline KW - Asherman syndrome KW - Hysteroscopy KW - Intercoat (Oxiplex/AP gel) KW - Intrauterine adhesions KW - Retained products of conception SP - 126 EP - 30 JF - Journal of minimally invasive gynecology JO - J Minim Invasive Gynecol VL - 21 IS - 1 N2 - STUDY OBJECTIVE: To evaluate the safety and effectiveness of Oxiplex/AP gel (Intercoat) in reducing intrauterine adhesion formation after hysteroscopic treatment because of retained products of conception (RPOC). DESIGN: Prospective double-blind, randomized, controlled pilot study (Canadian Task Force classification I). SETTING: Tertiary medical center. PATIENTS: All women who underwent hysteroscopic treatment because of RPOC at our institution between September 2009 and June 2012 were invited to participate. After operative hysteroscopy, participants were randomized to either have their uterine cavity filled with Oxiplex/AP gel (study group, n = 26) or not (control group, n = 26). INTERVENTIONS: Diagnostic office hysteroscopy to assess for adhesion formation was performed after 6 to 8 weeks. Findings were graded according to the American Fertility Society classification. Rates of subsequent pregnancy in the 2 groups were assessed. MEASUREMENTS AND MAIN RESULTS: Intraoperative complication rates were similar between the 2 groups. There were no postoperative complications after Oxiplex/AP gel application. Moderate to severe adhesions developed in 1 woman (4%) in the study group and 3 (14%) in the control group (p = .80). During follow-up of 20 months (range, 2-33 months), 7 women (27%) in the treatment group conceived, compared with 3 (14%) in the control group (p = .50). CONCLUSION: Intrauterine application of Oxiplex/AP gel after hysteroscopic removal of RPOC is safe. In this small sample, the difference in the rate of intrauterine adhesions was not statistically significant. A larger study would enable further establishment of the safety and efficacy of use of this gel. SN - 1553-4669 UR - https://www.unboundmedicine.com/medline/citation/23954387/Intercoat__Oxiplex/AP_gel__for_preventing_intrauterine_adhesions_after_operative_hysteroscopy_for_suspected_retained_products_of_conception:_double_blind_prospective_randomized_pilot_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1553-4650(13)00427-5 DB - PRIME DP - Unbound Medicine ER -