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.
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.


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


METHODS
Tertiary university hospital.


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


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


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.
Department of Obstetrics and Gynecology, Korea University College of Medicine, Seoul, South Korea.
Tak
T
Kim
Ki Hoon
KH
Ahn
Doo Seok
DS
Choi
Kyung Joo
KJ
Hwang
Byoung Ick
BI
Lee
Min Hyung
MH
Jung
Jae Weon
JW
Kim
Jong Hyuk
JH
Kim
Sun Hee
SH
Cha
Ki Hwan
KH
Lee
Kyu Sup
KS
Lee
Sung Tack
ST
Oh
Chi Heum
CH
Cho
Jeong Ho
JH
Rhee
D000328:Adult; D000464:Alginates / Q000009:adverse effects / Q000627:therapeutic use*; D002266:Carboxymethylcellulose Sodium / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005782:Gels; D006801:Humans; D006820:Hyaluronic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D015907:Hysteroscopy / Q000009:adverse effects; D012720:Severity of Illness Index; D016037:Single-Blind Method; D000267:Tissue Adhesions / Q000209:etiology / Q000517:prevention & control*; D014591:Uterine Diseases / Q000601:surgery*
D000464:Alginates; D005782:Gels; D006820:Hyaluronic Acid; D002266:Carboxymethylcellulose Sodium