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

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

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 Overview

• Status: Recruiting
• Conditions: Intrauterine Adhesion
• Intervention / Treatment: Procedure: cold knife; Procedure: hot knife

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.

• Study Type: Interventional
• Enrollment (Anticipated): 802
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaowu Huang; Phone Number: +8613810828816; Email: hxiaowu_fxyy@126.com

Study Locations

• China
  • Beijing, China, 100038
    • Recruiting
    • Fu Xing Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cold knife; The interference of the experimental group is to perform intrauterine adhesiolysis with scissors	Procedure: cold knife; 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.
Other: Hot knife; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fu Xing Hospital, Capital Medical University
• Investigators: Study Chair: Tinchiu Li, Fuxing Hospital,Capital Medical University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): August 31, 2022

Study Registration Dates

• First Submitted: June 18, 2021
• First Submitted That Met QC Criteria: June 18, 2021
• First Posted (Actual): June 23, 2021

Study Record Updates

• Last Update Posted (Actual): September 21, 2021
• Last Update Submitted That Met QC Criteria: September 20, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions
• Other Study ID Numbers: Z191100006619058

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No