Efficacy Of Intrauterine Isolator In Preventing Recurrence After Release Of Intrauterine Adhesion

Objective:At present,the preferred treatment for intrauterine adhesions is transcervical resection of adhesion(TCRA),but the recurrence after operation is still the primary problem in the treatment of intrauterine adhesions.Common methods for preventing recurrence include oral estrogen,placement of IUD,balloon catheters,and so on.However,the effects of these methods are not yet conclusive.Nanjing Minimally Invasive Medical Technology Co.,Ltd.independently developed an intrauterine isolator to prevent adhesion recurrence.This randomized controlled trial was conducted to evaluate the effect of intrauterine isolator in preventing recurrence after TCRA,and the safety of intrauterine isolator.Methods:This study was carried out in 66 patients that met the inclusion and exclusion criteria were selected from the clinic of reproductive center/gynecology of the Zhongda hospital affiliated to southeast university from August 2014 to November2017.These patients were divided into two groups.In group intrauterine isolator,33 patients were placed intrauterine isolator after TCRA,in group IUD,33 patients were placed TCu intra-uterine devices after TCRA.All patients completed relevant examinations(blood routine,liver and kidney function,blood coagulation routine,electrocardiogram,leucorrhea routine,TCT,pelvic ultrasound)before surgery.With normal test results patients were routinely scheduled for gynecologic surgery.Hysteroscopy was performed under intravenous anesthesia and performed AFS score of intrauterine adhesion.Then did TCRA with hysteroscopic scissors.At the end of the operation,an intrauterine isolator or a TCu intrauterine device are placed according to random grouping.Regular prophylactic anti-infective treatment for 48 hours.Collected the complications such as bleeding and infection on 7 days after surgery.The blood routine,liver and kidney function,blood coagulation routine,pelvic ultrasound,and second hysteroscopy were performed on 21-25 days after the operation.At the same time,removed the device in intrauterine.Endometrium morphology under hysteroscopy and endometrium thickness under b-mode ultrasound were observed.Finally,the SPSS 21.0 statistical software was used for data processing and analysis.Results:(1)General information: a total of 63 patients who completed the follow-up and were included in the statistical analysis were compared between the two groups in terms of age,previous intrauterine operation times,preoperative menstrual volume,etc.,and the difference was not statistically significant(P >0.05).(2)Only 1 of the 66 patients in group IUD had hemorrhage rehospitalization due to postoperative bleeding,with no significant difference.(3)Postoperative compared with preoperative,the change of AFS score in the experimental group and the control group is significant(Z<0.001);(4)The improvement of the endometrial thickness in the experimental group significantly(P<0.001).In the control group,there was no significant difference in the improvement of endometrial thickness before and after surgery(P>0.05).(5)The change of AFS scores and improvement in endometrial thickness of group intrauterine isolator was better than that of group IUD significantly(P=0.009,P=0.033).(6)The postoperative pregnancy rate was 51.5%(17/33)in the experimental group and 40%(12/30)in the control group.There was no significant difference in the pregnancy rate between the two groups(P>0.05).(7)Laboratory tests such as blood routine,liver function,blood coagulation function were performed before and after surgery in both groups.There were no significant differences in the preoperative and postoperative outcomes between the relevant indicators.Conclusion:For patients with intrauterine adhesions,placement of intrauterine isolator after TCRA can significantly reduce the AFS score during the second hysteroscopy,increase endometrial thickness,did not increase the incidence of complications,and has no significant impact on patients’ blood routine,liver function,etc.which is worthy of clinical application.However,there is no significant difference in postoperative pregnancy rate between two groups.Further large-scale experiments are needed for analysis later.