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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.
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:
Postoperative treatments
Follow up:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cold knife | Experimental | The interference of the experimental group is to perform intrauterine adhesiolysis with scissors |
|
| Hot knife | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cold knife | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence rate | Recurrence rate of intrauterine adhesions | 2 months after surgery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaowu Huang | Contact | +8613810828816 | hxiaowu_fxyy@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Tinchiu Li | Fuxing Hospital,Capital Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fu Xing Hospital, Capital Medical University | Recruiting | Beijing | 100038 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28603474 | Background | AAGL Elevating Gynecologic Surgery. AAGL practice report: practice guidelines on intrauterine adhesions developed in collaboration with the European Society of Gynaecological Endoscopy (ESGE). Gynecol Surg. 2017;14(1):6. doi: 10.1186/s10397-017-1007-3. Epub 2017 May 1. No abstract available. | |
| 30713131 | Background |
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| ID | Term |
|---|---|
| D006175 | Gynatresia |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D019092 | Conization |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
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| hot knife | Procedure | 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. |
|
| 2 months after surgery |
| Guo EJ, Chung JPW, Poon LCY, Li TC. Reproductive outcomes after surgical treatment of asherman syndrome: A systematic review. Best Pract Res Clin Obstet Gynaecol. 2019 Aug;59:98-114. doi: 10.1016/j.bpobgyn.2018.12.009. Epub 2019 Jan 3. |
| 3381869 | Background | Valle RF, Sciarra JJ. Intrauterine adhesions: hysteroscopic diagnosis, classification, treatment, and reproductive outcome. Am J Obstet Gynecol. 1988 Jun;158(6 Pt 1):1459-70. doi: 10.1016/0002-9378(88)90382-1. |
| 18406834 | Background | Yu D, Wong YM, Cheong Y, Xia E, Li TC. Asherman syndrome--one century later. Fertil Steril. 2008 Apr;89(4):759-79. doi: 10.1016/j.fertnstert.2008.02.096. |
| 29024798 | Background | Khan Z, Goldberg JM. Hysteroscopic Management of Asherman's Syndrome. J Minim Invasive Gynecol. 2018 Feb;25(2):218-228. doi: 10.1016/j.jmig.2017.09.020. Epub 2017 Oct 9. |
| 24082042 | Result | Hooker AB, Lemmers M, Thurkow AL, Heymans MW, Opmeer BC, Brolmann HA, Mol BW, Huirne JA. Systematic review and meta-analysis of intrauterine adhesions after miscarriage: prevalence, risk factors and long-term reproductive outcome. Hum Reprod Update. 2014 Mar-Apr;20(2):262-78. doi: 10.1093/humupd/dmt045. Epub 2013 Sep 29. |
| D000091662 | Genital Diseases |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |