Skip to content

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04936347
Enrollment
802
Registered
2021-06-23
Start date
2019-08-01
Completion date
2022-08-31
Last updated
2021-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrauterine Adhesion

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.

Interventions

PROCEDUREcold 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.

PROCEDUREhot 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.

Sponsors

Fu Xing Hospital, Capital Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Recurrence rate2 months after surgeryRecurrence rate of intrauterine adhesions

Secondary

MeasureTime frameDescription
Pregnancy rate1 year after the patient desire for pregnancyThe conception rate
Menstrual improvement rate2 months after surgeryThe patients' estrual improvement rate

Countries

China

Contacts

Primary ContactXiaowu Huang
hxiaowu_fxyy@126.com+8613810828816

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026