Clinical Trials Logo

Clinical Trial Summary

In this prospective, randomized controlled trial,the investigators wish to explore the difference of therapeutic effect and prognosis between "hot knife" and "cold knife" in the treatment of uterine adhesion under hysteroscopy.


Clinical Trial Description

1. Study Design:This is a prospective, randomized controlled trial.The investigators use hysteroscopy finding as standard reference. 2. Study population 802 patients diagnosed with intrauterine adhesions(IUA)will be prospectively recruited. Before the surgery all patients will undergo preoperative evaluations, including a detailed history of the menstrual pattern,any previous intrauterine surgery, and reproductive history, as well as trans-vaginal ultrasonography.The severity and extent of intrauterine adhesions will be scored according to the ESGE IUA grades. 3. Randomization: Randomization was performed electronically using SPSS statistical software version 26.0 (SPSS, Inc., Chicago, IL,USA) by the investigator.802 recruited patients will be randomized to one of the two treatment groups by computer-generated numbers: the control group("hot knife" group) and the experimental group("cold knife" group). 4. Surgical technique: - Hysteroscopic surgery will be performed in a standardized manner.The procedure will be performed under general anesthesia. Ultrasonographic guidance will be routinely used. - The interference of "cold knife" group (the experimental group) including 401 IUA patients is to perform intrauterine adhesiolysis with scissors, while the interference of "hot knife" group (the control group) is to perform intrauterine adhesiolysis with bipolar electric needle electrode, part of the scar tissue removed by electronic loop when it is necessary. - A Foley-catheter filled with 3.0-5.0 ml normal saline will be inserted into the uterus for 5-7 days after surgery. 5. Postoperative treatments - All subjects will be treated with oral antibiotics for 5-7 days. - All subjects will be treated with Hormone therapy. - A second-look hysteroscopy will be carried out in the early proliferative phase 4 weeks after the surgery and an optional third-look hysteroscopy will be carried out 8 weeks after the surgery. 6. Follow up: - Follow-up styles: the doctor's outpatient review, telephone, WeChat and so on. - Follow-up time:1 month, 2months, 12 months after the operation. - Follow up the results of hysteroscopy and the menstrual improvement and pregnancy outcomes at 12 months after the operation. 7. Consent: All subjects will be given a detailed explanation of the study and sufficient time to consider their participation. A written consent form will be signed by the patient and retained in the records. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04936347
Study type Interventional
Source Fu Xing Hospital, Capital Medical University
Contact Xiaowu Huang
Phone +8613810828816
Email hxiaowu_fxyy@126.com
Status Recruiting
Phase N/A
Start date August 1, 2019
Completion date August 31, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT04972032 - Efficacy of Estrogen-intrauterine Stent System After Intrauterine Adhesiolysis N/A
Recruiting NCT03381807 - Human Amniotic Epithelial Stem Cell in Treatment of Refractory Severe Intrauterine Adhesion Early Phase 1
Recruiting NCT03329898 - Comparing the Efficacy of Two Methods for the Therapy of Uterine Adhesion N/A
Completed NCT03724617 - Clinical Study of Umbilical Cord Mesenchymal Stem Cells Combined With Collagen Scaffold in the Treatment of Thin Endometrium N/A
Recruiting NCT03330873 - The Efficacy and Safety of Disposable Balloon Uterine Stent in Patients With Asherman Syndrome N/A
Completed NCT02220621 - Efficacy and Safety of Crosslinked Hyaluronan Gel for Preventing Intrauterine Adhesion N/A
Active, not recruiting NCT04963179 - PREvention of Intrauterine Adhesion After Adhesiolysis With Novel Tri-block deGradable Polymer Film. N/A
Recruiting NCT03351205 - The Efficacy of Estrogen Therapy Against Adhesion Reformation After Hysteroscopic Adhesiolysis N/A
Completed NCT04381728 - PREvention of Intrauterine Adhesion After Hysteroscopic Surgery With Novel deGradable Film N/A
Recruiting NCT03346317 - Comparing the Efficacy of Two Methods in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis N/A
Completed NCT05414760 - Evaluate Formation of IUAs After Third-generation Endometrial Ablation, With and Without Intrauterine Adhesion Barrier N/A
Completed NCT04166500 - Early Outpatient Hysteroscopy Can Prevent Intrauterine Adhesion After Induced Abortion N/A
Recruiting NCT03169478 - Intrauterine Balloon Dilatation Therapy in the Prevention of Adhesion Formation After Hysteroscopic Myomectomy N/A
Recruiting NCT03171454 - Immediate and Delayed Intrauterine Balloon in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis N/A
Recruiting NCT05003869 - Clinical and Basic Research on the Necessity of Scar Tissue Resection During Intrauterine Adhesions N/A
Completed NCT02744716 - Effects of Aspirin on Uterine Endometrial Repair Severe Intrauterine Adhesion N/A
Completed NCT03131596 - Postoperative Intermittent Intrauterine Balloon Dilatation Therapy. N/A
Completed NCT04824430 - Assessment of Uterine Access, Uterine Patency and Intrauterine Adhesions Following Endometrial Ablation
Completed NCT01167296 - Safety of Leaving Cook Balloon Uterine Stent in Uterus for One Month Phase 4
Completed NCT03578172 - HMG Stimulation Versus HRT for Endometrial Preparation Prior to Blastocyst Transfer in Moderate to Severe IUA Patients N/A