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[Prevention of intrauterine adhesion with auto-crosslinked hyaluronic acid gel: a prospective, randomized, controlled clinical study].
Zhonghua Fu Chan Ke Za Zhi. 2015 Jan; 50(1):32-6.ZF

Abstract

OBJECTIVE

To evaluate the efficacy and safety of auto-crosslinked hyaluronic acid (HA) gel for preventing intrauterine adhesion (IUA) after hysteroscopic adhesiolysis.

METHODS

A prospective, randomized, double blinded and controlled clinical trial (level I) was performed. According to American Fertility Society (AFS) scoring system, 120 patients (treatment group: 60 cases, control group: 60 cases) with moderate to severe IUA were enrolled. Upon completion of adhesiolysis, a Foley balloon catheter was first introduced into the uterine cavity and then 3 ml of auto-crosslinked HA gel for patients in the treatment group; patients in the control group, however, only received Foley balloon catheter. Second-look hysteroscopic examination was performed to all patients at 3 months postoperatively for evaluation of IUA. Primary endpoint was the reduction rate of IUA at 3 months after surgery. The secondary endpoints include total AFS score, score of each individual AFS category.

RESULTS

At 3 months after surgery, auto-crosslinked HA gel resulted in significantly higher effective rate for reduction of adhesion, the effective rate were 76% (42/55) and 48% (27/56) respectively (P = 0.000 9); the total AFS score of treatment group was 2.1 ± 1.1, and significantly lower than that of control group (3.7 ± 2.5, P = 0.000 8). Application of auto-crosslinked HA gel after surgery significantly enhanced the improvement for each individual patient with regard to their adhesive type and menstrual pattern (P = 0.037 8, P = 0.000 4). The treatment group had significantly lower proportion of patients with moderate to severe adhesive stages than that of control group [13% (7/55) versus 38% (21/56), P = 0.000 6]. No adverse events and complications were observed.

CONCLUSIONS

Auto-crosslinked HA gel coule be able to reduce IUA, decrease adhesion severity, and improve menopause postoperatively. This absorbable auto-crosslinked HA gel is proposed as a barrier for preventing IUA after intrauterine procedures.

Authors+Show Affiliations

Department of Obstetrics and Gynecology, the Third Xiangya Hospital of Central South University, Changsha 410013, China.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableEmail: xueminxy3@163.com.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

chi

PubMed ID

25877422

Citation

Xiao, Songshu, et al. "[Prevention of Intrauterine Adhesion With Auto-crosslinked Hyaluronic Acid Gel: a Prospective, Randomized, Controlled Clinical Study]." Zhonghua Fu Chan Ke Za Zhi, vol. 50, no. 1, 2015, pp. 32-6.
Xiao S, Wan Y, Zou F, et al. [Prevention of intrauterine adhesion with auto-crosslinked hyaluronic acid gel: a prospective, randomized, controlled clinical study]. Zhonghua Fu Chan Ke Za Zhi. 2015;50(1):32-6.
Xiao, S., Wan, Y., Zou, F., Ye, M., Deng, H., Ma, J., Wei, Y., Tan, C., & Xue, M. (2015). [Prevention of intrauterine adhesion with auto-crosslinked hyaluronic acid gel: a prospective, randomized, controlled clinical study]. Zhonghua Fu Chan Ke Za Zhi, 50(1), 32-6.
Xiao S, et al. [Prevention of Intrauterine Adhesion With Auto-crosslinked Hyaluronic Acid Gel: a Prospective, Randomized, Controlled Clinical Study]. Zhonghua Fu Chan Ke Za Zhi. 2015;50(1):32-6. PubMed PMID: 25877422.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - [Prevention of intrauterine adhesion with auto-crosslinked hyaluronic acid gel: a prospective, randomized, controlled clinical study]. AU - Xiao,Songshu, AU - Wan,Yajun, AU - Zou,Fangjun, AU - Ye,Mingzhu, AU - Deng,Henan, AU - Ma,Jiezhi, AU - Wei,Yingying, AU - Tan,Chen, AU - Xue,Min, PY - 2015/4/17/entrez PY - 2015/4/17/pubmed PY - 2015/9/2/medline SP - 32 EP - 6 JF - Zhonghua fu chan ke za zhi JO - Zhonghua Fu Chan Ke Za Zhi VL - 50 IS - 1 N2 - OBJECTIVE: To evaluate the efficacy and safety of auto-crosslinked hyaluronic acid (HA) gel for preventing intrauterine adhesion (IUA) after hysteroscopic adhesiolysis. METHODS: A prospective, randomized, double blinded and controlled clinical trial (level I) was performed. According to American Fertility Society (AFS) scoring system, 120 patients (treatment group: 60 cases, control group: 60 cases) with moderate to severe IUA were enrolled. Upon completion of adhesiolysis, a Foley balloon catheter was first introduced into the uterine cavity and then 3 ml of auto-crosslinked HA gel for patients in the treatment group; patients in the control group, however, only received Foley balloon catheter. Second-look hysteroscopic examination was performed to all patients at 3 months postoperatively for evaluation of IUA. Primary endpoint was the reduction rate of IUA at 3 months after surgery. The secondary endpoints include total AFS score, score of each individual AFS category. RESULTS: At 3 months after surgery, auto-crosslinked HA gel resulted in significantly higher effective rate for reduction of adhesion, the effective rate were 76% (42/55) and 48% (27/56) respectively (P = 0.000 9); the total AFS score of treatment group was 2.1 ± 1.1, and significantly lower than that of control group (3.7 ± 2.5, P = 0.000 8). Application of auto-crosslinked HA gel after surgery significantly enhanced the improvement for each individual patient with regard to their adhesive type and menstrual pattern (P = 0.037 8, P = 0.000 4). The treatment group had significantly lower proportion of patients with moderate to severe adhesive stages than that of control group [13% (7/55) versus 38% (21/56), P = 0.000 6]. No adverse events and complications were observed. CONCLUSIONS: Auto-crosslinked HA gel coule be able to reduce IUA, decrease adhesion severity, and improve menopause postoperatively. This absorbable auto-crosslinked HA gel is proposed as a barrier for preventing IUA after intrauterine procedures. SN - 0529-567X UR - https://www.unboundmedicine.com/medline/citation/25877422/[Prevention_of_intrauterine_adhesion_with_auto_crosslinked_hyaluronic_acid_gel:_a_prospective_randomized_controlled_clinical_study]_ L2 - http://journal.yiigle.com/LinkIn.do?linkin_type=pubmed&issn=0529-567X&year=2015&vol=50&issue=1&fpage=32 DB - PRIME DP - Unbound Medicine ER -