Hysteroscopic Hot Knife and Cold Knife in the Treatment of the Intrauterine Adhesion

Study Overview
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Brief Summary
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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.

Detailed Description
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Study Design：This is a prospective, randomized controlled trial.The investigators use hysteroscopy finding as standard reference. 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. 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). 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. 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. 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. 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.

Official Title
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A Randomized Controlled Study of Bipolar Electric Cutting and Scissors Under Hysteroscopy in the Treatment of the Intrauterine Adhesion

Conditions
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Intrauterine Adhesion

Intervention / Treatment
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* Procedure: cold knife
* Procedure: hot knife


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indications: fertility desire, periodic pelvic pain; Women aged 18-40 years; Moderate to severe intrauterine adhesion(ESGE Grade II-IV); All enrolled women provided written informed consent and agree to the entire study protocol prior to surgery Exclusion Criteria: Contraindications: such as severe medical diseases, pregnancy status, reproductive tract infection, malignant tumor; History of uterine artery embolization; Infertility caused by male factors or ovarian dysfunction or premature ovarian failure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cold knife<br>The interference of the experimental group is to perform intrauterine adhesiolysis with scissors | Procedure: cold knife<br>* Transcervical resection of adhesions is performed with scissors to restore the shape of uterine cavity, promote the regeneration and repair of endometrium, and ultimately improve the reproductive prognosis of patients.<br>|
| Other: Hot knife<br>The interference of 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. | Procedure: hot knife<br>* Transcervical resection of adhesions is performed with bipolar electric cutting to restore the shape of uterine cavity, promote the regeneration and repair of endometrium, and ultimately improve the reproductive prognosis of patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate | Recurrence rate of intrauterine adhesions | 2 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate | The conception rate | 1 year after the patient desire for pregnancy | 
| Menstrual improvement rate | The patients' estrual improvement rate | 2 months after surgery |