Xue Yang1, Yuhuan Liu2, Tin-Chiu Li3, Enlan Xia1, Yu Xiao1, Fengqiong Zhou1, Dongmei Song1, Qiaoyun Zhou1. 1. Hysteroscopy Center, Fu Xing Hospital, Capital Medical University, Beijing 100038, China. 2. Hysteroscopy Center, Fu Xing Hospital, Capital Medical University, Beijing 100038, China. Electronic address: liuyh3844@sina.com. 3. Hysteroscopy Center, Fu Xing Hospital, Capital Medical University, Beijing 100038, China; Department of Obstetrics and Gynecology, Prince of Wales Hospital, The Chinese University of Hong Kong, ShatinHong Kong 852, China.
Abstract
RESEARCH QUESTION: Does placing an intrauterine balloon for different durations (7, 14 or 28 days) affect the recurrence of intrauterine adhesions after hysteroscopic adhesiolysis? DESIGN: Prospective randomized control trial involving 138 patients recruited over a 12-month period and followed up post-operatively for 15 months. The primary outcome measure was the rate of adhesion reformation at third-look hysteroscopy. RESULTS: At third-look hysteroscopy, 8 weeks after the initial hysteroscopy, the adhesion recurrence rate in women who had an intrauterine balloon for 28 days (20%) was significantly (P < 0.01) lower than that of women who had the balloon for 14 days (55%) or 7 days (36.8%). CONCLUSIONS: Placing an intrauterine balloon for 28 days instead of 7 or 14 days after hysteroscopic adhesiolysis resulted in a greater reduction in the recurrence rate of adhesions. However, the study was underpowered to address whether the ongoing pregnancy rate could be improved by keeping the balloon in the uterine cavity for a longer period of time.
RCT Entities:
RESEARCH QUESTION: Does placing an intrauterine balloon for different durations (7, 14 or 28 days) affect the recurrence of intrauterine adhesions after hysteroscopic adhesiolysis? DESIGN: Prospective randomized control trial involving 138 patients recruited over a 12-month period and followed up post-operatively for 15 months. The primary outcome measure was the rate of adhesion reformation at third-look hysteroscopy. RESULTS: At third-look hysteroscopy, 8 weeks after the initial hysteroscopy, the adhesion recurrence rate in women who had an intrauterine balloon for 28 days (20%) was significantly (P < 0.01) lower than that of women who had the balloon for 14 days (55%) or 7 days (36.8%). CONCLUSIONS: Placing an intrauterine balloon for 28 days instead of 7 or 14 days after hysteroscopic adhesiolysis resulted in a greater reduction in the recurrence rate of adhesions. However, the study was underpowered to address whether the ongoing pregnancy rate could be improved by keeping the balloon in the uterine cavity for a longer period of time.