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A randomized, multi-center, clinical trial to assess the efficacy and safety of alginate carboxymethylcellulose hyaluronic acid compared to carboxymethylcellulose hyaluronic acid to prevent postoperative intrauterine adhesion.
J Minim Invasive Gynecol. 2012 Nov-Dec; 19(6):731-6.JM

Abstract

STUDY OBJECTIVE

To estimate the efficacy of alginate carboxymethylcellulose hyaluronic acid (ACH) gel to prevent intrauterine adhesions after hysteroscopic surgery in comparison with carboxymethylcellulose hyaluronic acid (CH) gel, which is known as an effective adhesion inhibitor.

DESIGN

Randomized, multicenter, single-blind, clinical trial (Canadian Task Force classification I).

SETTING

Tertiary university hospital.

PATIENTS

One hundred eighty-seven patients with a surgically treatable intrauterine lesion (myomas, polyps, septa, intrauterine adhesion, dysfunctional uterine bleeding).

INTERVENTIONS

Patients were randomized to 2 groups: hysteroscopic surgery plus intrauterine application of ACH or CH.

MEASUREMENTS AND RESULTS

The rate of adhesion formation and the adhesion severity score with type and extent were calculated 4 weeks after surgery. The ACH group had results that were comparable to the CH group in terms of the development of intrauterine adhesions at 4 weeks follow-up. The adhesion severities were not different between the 2 groups. In a subgroup without baseline intrauterine adhesion, the ACH group showed a lower intrauterine adhesion rate than the CH group (p = .016).

CONCLUSIONS

ACH had a comparable efficacy to CH in terms of the adhesion rate and severity. In the case of no baseline intrauterine adhesion, intrauterine application of ACH after hysteroscopic surgery had a lower rate of intrauterine adhesion than application of CH.

Authors+Show Affiliations

Department of Obstetrics and Gynecology, Korea University College of Medicine, Seoul, South Korea.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23084677

Citation

Kim, Tak, et al. "A Randomized, Multi-center, Clinical Trial to Assess the Efficacy and Safety of Alginate Carboxymethylcellulose Hyaluronic Acid Compared to Carboxymethylcellulose Hyaluronic Acid to Prevent Postoperative Intrauterine Adhesion." Journal of Minimally Invasive Gynecology, vol. 19, no. 6, 2012, pp. 731-6.
Kim T, Ahn KH, Choi DS, et al. A randomized, multi-center, clinical trial to assess the efficacy and safety of alginate carboxymethylcellulose hyaluronic acid compared to carboxymethylcellulose hyaluronic acid to prevent postoperative intrauterine adhesion. J Minim Invasive Gynecol. 2012;19(6):731-6.
Kim, T., Ahn, K. H., Choi, D. S., Hwang, K. J., Lee, B. I., Jung, M. H., Kim, J. W., Kim, J. H., Cha, S. H., Lee, K. H., Lee, K. S., Oh, S. T., Cho, C. H., & Rhee, J. H. (2012). A randomized, multi-center, clinical trial to assess the efficacy and safety of alginate carboxymethylcellulose hyaluronic acid compared to carboxymethylcellulose hyaluronic acid to prevent postoperative intrauterine adhesion. Journal of Minimally Invasive Gynecology, 19(6), 731-6. https://doi.org/10.1016/j.jmig.2012.08.003
Kim T, et al. A Randomized, Multi-center, Clinical Trial to Assess the Efficacy and Safety of Alginate Carboxymethylcellulose Hyaluronic Acid Compared to Carboxymethylcellulose Hyaluronic Acid to Prevent Postoperative Intrauterine Adhesion. J Minim Invasive Gynecol. 2012 Nov-Dec;19(6):731-6. PubMed PMID: 23084677.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized, multi-center, clinical trial to assess the efficacy and safety of alginate carboxymethylcellulose hyaluronic acid compared to carboxymethylcellulose hyaluronic acid to prevent postoperative intrauterine adhesion. AU - Kim,Tak, AU - Ahn,Ki Hoon, AU - Choi,Doo Seok, AU - Hwang,Kyung Joo, AU - Lee,Byoung Ick, AU - Jung,Min Hyung, AU - Kim,Jae Weon, AU - Kim,Jong Hyuk, AU - Cha,Sun Hee, AU - Lee,Ki Hwan, AU - Lee,Kyu Sup, AU - Oh,Sung Tack, AU - Cho,Chi Heum, AU - Rhee,Jeong Ho, PY - 2012/05/11/received PY - 2012/08/01/revised PY - 2012/08/02/accepted PY - 2012/10/23/entrez PY - 2012/10/23/pubmed PY - 2013/5/4/medline SP - 731 EP - 6 JF - Journal of minimally invasive gynecology JO - J Minim Invasive Gynecol VL - 19 IS - 6 N2 - STUDY OBJECTIVE: To estimate the efficacy of alginate carboxymethylcellulose hyaluronic acid (ACH) gel to prevent intrauterine adhesions after hysteroscopic surgery in comparison with carboxymethylcellulose hyaluronic acid (CH) gel, which is known as an effective adhesion inhibitor. DESIGN: Randomized, multicenter, single-blind, clinical trial (Canadian Task Force classification I). SETTING: Tertiary university hospital. PATIENTS: One hundred eighty-seven patients with a surgically treatable intrauterine lesion (myomas, polyps, septa, intrauterine adhesion, dysfunctional uterine bleeding). INTERVENTIONS: Patients were randomized to 2 groups: hysteroscopic surgery plus intrauterine application of ACH or CH. MEASUREMENTS AND RESULTS: The rate of adhesion formation and the adhesion severity score with type and extent were calculated 4 weeks after surgery. The ACH group had results that were comparable to the CH group in terms of the development of intrauterine adhesions at 4 weeks follow-up. The adhesion severities were not different between the 2 groups. In a subgroup without baseline intrauterine adhesion, the ACH group showed a lower intrauterine adhesion rate than the CH group (p = .016). CONCLUSIONS: ACH had a comparable efficacy to CH in terms of the adhesion rate and severity. In the case of no baseline intrauterine adhesion, intrauterine application of ACH after hysteroscopic surgery had a lower rate of intrauterine adhesion than application of CH. SN - 1553-4669 UR - https://www.unboundmedicine.com/medline/citation/23084677/A_randomized_multi_center_clinical_trial_to_assess_the_efficacy_and_safety_of_alginate_carboxymethylcellulose_hyaluronic_acid_compared_to_carboxymethylcellulose_hyaluronic_acid_to_prevent_postoperative_intrauterine_adhesion_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1553-4650(12)00336-6 DB - PRIME DP - Unbound Medicine ER -