Comparison of therapeutic efficacy of three methods to prevent re-adhesion after hysteroscopic intrauterine adhesion separation: a parallel, randomized and single-center trial
| Autor: | Yang Zhou, Ming Li, Qinghua Xi, Yiqian Ding, Jinxin Qiu, Wei Liu, Yanjun Sun, Xiaomin Zhang |
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| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Randomization Uterine perforation Tissue Adhesions Hysteroscopy Menstruation Postoperative Complications Pregnancy medicine Humans Lost to follow-up Child Uterine Diseases Advanced and Specialized Nursing medicine.diagnostic_test business.industry medicine.disease Surgery Clinical trial Anesthesiology and Pain Medicine medicine.anatomical_structure Female Uterine cavity business Intrauterine Devices |
| Zdroj: | Annals of Palliative Medicine. 10:6804-6823 |
| ISSN: | 2224-5839 2224-5820 |
| DOI: | 10.21037/apm-21-1296 |
| Popis: | This research aims to study the efficacy of an integrated approach to prevent and treat the recurrence of intrauterine adhesions (IUA) after hysteroscopic adhesiolysis.A total of 96 patients diagnosed with moderate-to-severe intrauterine adhesions (IUA) in Nantong Maternal and Child Health Hospital from January 2016 to December 2019 were included in this parallel, randomized and single-center trial. Moderate (48 cases) and severe (48 cases) patients were randomly divided into three groups by a computer random generator: Group A (IUD, n=16), Group B, (Foley1w+IUD, n=16) and Group C (Foley1m+IUD, n=16). All patients received sequential treatment of estrogen and progesterone on the day of operation. Follow-up was performed at 1 and 3 months after treatment of uterine cavity, endometrial thickness, menstruation and pregnancy. Surgeons who performed the second-look and third-look hysteroscopy and postsurgical assessors were blinded to the randomization.In total, 96 patients (48 cases in each degree) were included in the final analysis, with 16 cases in each group. No cases were lost to follow up. The primary outcome measure was AFS score, which was significantly lower in Group C than that of women in group A and Group B at 1 month (P0.05). Similar results were observed at 3-month follow up. In patients with moderate adhesions, the pregnancy rate in Group C (Foley1m+IUD) was higher than that in Group A and Group B (P0.05). However, in patients with severe adhesions, there was no significant difference in the pregnancy rate among the three groups (P0.05). There was no statistical significance in infection indicators among the three groups of moderate and severe patients (P0.05). Postoperative complications such as uterine perforation, severe bleeding, water poisoning and intrauterine infection were not observed.The effect of a Foley intrauterine balloon combined with IUD in preventing re-adhesion was better than that of an IUD alone. For patients with moderate adhesion, the prolongation of placement time could prevent intrauterine re-adhesion and significantly improve the pregnancy rate with strong safety. However, for patients with severe adhesions, the prolongation of intrauterine Foley balloon placement did not better prevent intrauterine re-adhesions, improve menstruation, or improve pregnancy rates.Chinese Clinical Trial Registry ChiCTR2100046945. |
| Databáze: | OpenAIRE |
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