Clinical trial NCT04936347: Hysteroscopic "Hot Knife" and "Cold Knife" in the Treatment of the Intrauterine Adhesion
Official title: A Randomized Controlled Study of Bipolar Electric Cutting and Scissors Under Hysteroscopy in the Treatment of the Intrauterine Adhesion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intrauterine Adhesion
Lead sponsor: Fu Xing Hospital, Capital Medical University
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 802
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Recurrence rate
timeFrame: 2 months after surgery
Secondary outcomes:
measure: Pregnancy rate
timeFrame: 1 year after the patient desire for pregnancy
measure: Menstrual improvement rate
timeFrame: 2 months after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fu Xing Hospital, Capital Medical University
Study officials:
affiliation: Fuxing Hospital,Capital Medical University
name: Tinchiu Li
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.