Crosslinked Hyaluronic Acid Gels for the Prevention of Intrauterine Adhesions after a Hysteroscopic Myomectomy in Women with Submucosal Myomas: A Prospective, Randomized, Controlled Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design and Participants
2.2. Procedures
2.3. Outcomes
2.4. Statistical Analysis
3. Results
3.1. The Characteristics of the Study Subjects
3.2. The Outcomes
3.3. The Precipitating Factors for the Development of Modified American Fertility Society Stage II–III (Moderate and Severe) Intrauterine Adhesion
3.4. The Adverse Events
4. Discussion
4.1. Main Findings
4.2. Comparing with Other Randomized Controlled Trials (RCT) Using Hyaluronic Acid for the Primary Prevention of the Development of Intrauterine Adhesion after Hysteroscopic Myomectomy
4.3. Precipitating Factors Associated with an Increased Risk of the Development of Modified American Fertility Society Stage II–III (Moderate and Severe) Intrauterine Adhesion
4.4. The Strengths and Limitations
5. Conclusions
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
Abbreviations
AFS | American Fertility Society |
CHA | Crosslinked hyaluronic acid |
CHA-P | Crosslinked hyaluronic acid platform |
CI | Confidence interval |
D and C | Dilation and curettage |
FIGO | International Federation of Gynecology and Obstetrics |
IUA | Intrauterine adhesion or intrauterine adhesions |
OR | Odds ratio |
RCT | Randomized controlled trial |
SD | Standard deviation |
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Scores | Description |
---|---|
1 | Filmy adhesions with less than 1/3 enclosure |
2 | Filmy adhesions with 1/3 to 2/3 enclosure |
4 | Filmy adhesions with more than 2/3 enclosure |
4 | Dense adhesions with less than 1/3 enclosure |
8 | Dense adhesions with 1/3 to 2/3 enclosure |
16 | Dense adhesions with more than 2/3 enclosure |
Characteristics | Treatment (n = 47) | No Treatment (n = 23) | p Value | |
---|---|---|---|---|
Characteristics of Patients | ||||
Age (years) | 45.4 ± 3.6 | 45.2 ± 4.4 | 0.825 | |
Body mass index (Kg/m2) | 23.8 ± 3.6 | 22.7 ± 2.7 | 0.202 | |
*Previous Uterine Surgery | 0.190 | |||
No | 37 (78.7%) | 21 (91.3%) | ||
Yes | 10 (21.3%) | 2 (8.7%) | ||
Abortion History | 0.265 | |||
No | 33 (70.2%) | 19 (82.6%) | ||
Yes | 14 (29.8%) | 4 (17.4%) | ||
Gravidity | 1.15 ± 0.98 | 0.78 ± 0.85 | 0.130 | |
Gravidity, times | 0.625 | |||
0 | 13 (27.7%) | 10 (43.5%) | ||
1 | 19 (40.4%) | 9 (39.1%) | ||
2 | 11 (23.4%) | 3 (13.0%) | ||
3 | 3 (6.4%) | 1 (4.3%) | ||
4 | 1 (2.1%) | 0 | ||
Parity | 0.79 ± 0.72 | 0.61 ± 0.66 | 0.320 | |
Parity, times | 0.579 | |||
0 | 18 (38.3%) | 11 (47.8%) | ||
1 | 21 (44.7%) | 10 (43.5%) | ||
2 | 8 (17.0%) | 2 (8.7%) | ||
Characteristics of Myomas | 0.900 | |||
FIGO type | Type 1 | 32 (68.1%) | 16 (69.6%) | |
Type 2 | 15 (31.9%) | 7 (30.4%) | ||
Number | 1.3 ± 0.5 | 1.3 ± 0.5 | 0.957 | |
Maximal diameter (cm) | 2.4 ± 0.5 | 2.2 ± 0.8 | 0.250 | |
Maximal volume (cm3) | 5.4 ± 3.2 | 4.1 ± 4.0 | 0.154 |
Treatment (n = 47) | No Treatment (n = 23) | p Value | |
---|---|---|---|
Intrauterine Adhesion | 0.012 | ||
No | 41 (87.2%) | 14 (60.9%) | |
Yes | 6 (12.8%) | 9 (39.1%) | |
Modified AFS Stage | 0.002 | ||
0 | 41 (87.2%) | 14 (60.9%) | |
I (mild) | 5 (10.6%) | 1 (4.3%) | |
II (moderate) | 1 (2.1%) | 4 (17.4%) | |
III (severe) | 0 | 4 (17.4%) |
CHA-P Gel (n = 24) | CHA Gel (n = 23) | No (n = 23) | p-Value | |
---|---|---|---|---|
Intrauterine Adhesion | 0.031 | |||
No | 22 (91.7%) a | 19 (82.6%) a | 14 (60.9%) | |
Yes | 2 (8.3%) a | 4 (17.4%) a | 9 (39.1%) | |
Modified AFS Stage | 0.014 | |||
0 | 22 (91.7%) b | 19 (82.6%) b | 14 (60.9%) | |
I (mild) | 2 (8.3%) b | 3 (13.0%) b | 1 (4.3%) | |
II (moderate) | 0 b | 1 (4.3%) b | 4 (17.4%) | |
III (severe) | 0 b | 0b | 4 (17.4%) |
Characteristics | n | Odds Ratio (95% CI) | p-Value |
---|---|---|---|
Characteristics of Patients | |||
Age (years) | |||
<43.9 | 27 | 1 (Reference) | |
≥43.9 | 43 | 3.03 (1.90–4.83) | <0.0001 |
Body Mass Index (Kg/m2) | |||
<23.22 | 32 | 1 (Reference) | |
≥23.22 | 38 | 4.11 (2.38–7.13) | <0.0001 |
*Previous Uterine Surgery | |||
No | 58 | 1 (Reference) | |
Yes | 12 | 2.63 (1.81–3.80) | <0.0001 |
Abortion History | |||
No | 52 | 1 (Reference) | |
Yes | 18 | 2.99 (1.97–4.53) | <0.0001 |
Gravidity | |||
<2 | 51 | 1 (Reference) | |
≥2 | 19 | 2.99 (1.97–4.55) | <0.0001 |
Parity | |||
<2 | 60 | 1 (Reference) | |
≥2 | 10 | 2.72 (1.87–3.96) | <0.0001 |
Characteristics of Myoma | |||
FIGO Type | |||
1 | 48 | 1 (Reference) | |
2 | 22 | 3.75 (2.28–6.17) | <0.0001 |
Number | |||
1 | 49 | 1 (Reference) | |
>1 | 21 | 3.32 (2.11–5.23) | <0.0001 |
Maximal diameter | |||
≤2.7 cm | 51 | 1 (Reference) | |
>2.7 cm | 19 | 3.70 (2.27–6.02) | <0.0001 |
Maximal volume | |||
≤6.8 cm3 | 47 | 1 (Reference) | |
>6.8 cm3 | 23 | 3.54 (2.20–5.72) | <0.0001 |
Application of Postoperative Anti-Adhesive Gels | |||
No | 23 | 1 (Reference) | |
Yes | 47 | 0.25 (0.15–0.42) | <0.0001 |
Odds Ratio (95% Confidence Interval) | p-Value | |
---|---|---|
FIGO type | ||
1 | 1 (Reference) | |
2 | 108.36 (8.95–1312.54) | <0.0001 |
Application of Postoperative Anti-Adhesive Gels | ||
No | 1 (Reference) | |
Yes | 0.04 (0.00–0.33) | 0.003 |
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Share and Cite
Huang, C.-Y.; Chang, W.-H.; Cheng, M.; Huang, H.-Y.; Horng, H.-C.; Chen, Y.-J.; Lee, W.-L.; Wang, P.-H. Crosslinked Hyaluronic Acid Gels for the Prevention of Intrauterine Adhesions after a Hysteroscopic Myomectomy in Women with Submucosal Myomas: A Prospective, Randomized, Controlled Trial. Life 2020, 10, 67. https://doi.org/10.3390/life10050067
Huang C-Y, Chang W-H, Cheng M, Huang H-Y, Horng H-C, Chen Y-J, Lee W-L, Wang P-H. Crosslinked Hyaluronic Acid Gels for the Prevention of Intrauterine Adhesions after a Hysteroscopic Myomectomy in Women with Submucosal Myomas: A Prospective, Randomized, Controlled Trial. Life. 2020; 10(5):67. https://doi.org/10.3390/life10050067
Chicago/Turabian StyleHuang, Chen-Yu, Wen-Hsun Chang, Min Cheng, Hsin-Yi Huang, Huann-Cheng Horng, Yi-Jen Chen, Wen-Ling Lee, and Peng-Hui Wang. 2020. "Crosslinked Hyaluronic Acid Gels for the Prevention of Intrauterine Adhesions after a Hysteroscopic Myomectomy in Women with Submucosal Myomas: A Prospective, Randomized, Controlled Trial" Life 10, no. 5: 67. https://doi.org/10.3390/life10050067