Intrauterine AdhesionNCT04936347
Hysteroscopic "Hot Knife" and "Cold Knife" in the Treatment of the Intrauterine Adhesion
A study testing cold knife and hot knife in people with Intrauterine Adhesion, run by Fu Xing Hospital, Capital Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Intrauterine Adhesion
- What is being tested?
- cold knife and hot knife
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 802 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fu Xing Hospital, Capital Medical University
Beijing, 100038
luo wen, +86 010-88062291, fxyykjk@sina.com
About this study
Official title: 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.
Read the detailed description
- 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.
- Conditions
- Intrauterine Adhesion
- Being tested
- cold knife, hot knife
- Medical subject headings
- Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cold knifeProcedure or surgery
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.
hot knifeProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Cold knife | Experimental | The interference of the experimental group is to perform intrauterine adhesiolysis with scissors Receives: Procedure: cold knife |
| 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. Receives: Procedure: hot knife |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
Recurrence rate of intrauterine adhesions
Measured: 2 months after surgery
Secondary outcomes (2)
Pregnancy rate
The conception rate
Measured: 1 year after the patient desire for pregnancy
Menstrual improvement rate
The patients' estrual improvement rate
Measured: 2 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start1 Aug 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Intrauterine AdhesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 802 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Xing Hospital, Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaowu Huang, Fu Xing Hospital, Capital Medical University
- Investigators
- Tinchiu Li, Study chair, Fuxing Hospital,Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936347
- Sponsor's protocol ID
- Z191100006619058
- Status last verified
- Jun 2021
- First submitted
- 18 Jun 2021
- Last updated
- 21 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28603474Guo 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.
PubMed 30713131Valle 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.
PubMed 3381869Yu 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.
PubMed 18406834Khan 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.
PubMed 29024798Hooker 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.
PubMed 24082042
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Bipolar Electric Cutting and Scissors Under Hysteroscopy in the Treatment of the Intrauterine Adhesion
- ClinicalTrials.gov ID
- NCT04936347
- Acronym / sponsor ID
- Z191100006619058
- Conditions
- Intrauterine Adhesion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 802 participants (estimated)
- Lead sponsor
- Fu Xing Hospital, Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold knife | Experimental | Procedure: cold knifeThe interference of the experimental group is to perform intrauterine adhesiolysis with scissors |
| Hot knife | Other | Procedure: hot knifeThe 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cold knifeTranscervical 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. | Procedure or surgery | Cold knife |
| hot knifeTranscervical 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. | Procedure or surgery | Hot knife |
Primary outcome
Recurrence rate
Time frame: 2 months after surgery
Recurrence rate of intrauterine adhesions
2 secondary outcomes
Pregnancy rate
Time frame: 1 year after the patient desire for pregnancy
Menstrual improvement rate
Time frame: 2 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- Background: PubMed 28603474AAGL 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.
- Background: PubMed 30713131Guo 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.
- Background: PubMed 3381869Valle 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.
- Background: PubMed 18406834Yu 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.
- Background: PubMed 29024798Khan 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.
- Results publication: PubMed 24082042Hooker 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tinchiu Li study chair
Fuxing Hospital,Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cold knife and hot knife in people with Intrauterine Adhesion, run by Fu Xing Hospital, Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaowu Huang (+8613810828816, hxiaowu_fxyy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate (time frame: 2 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04936347, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.