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

NCT04936347 | Unknown

• 1 other identifier: Z191100006619058
• Study Type: interventional
• Target: 802
• Locations: 1 country
• Sites: 1

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.

Conditions

Intrauterine Adhesion

Outcome Measures

Primary Outcomes (1)

• Recurrence rate

  Recurrence rate of intrauterine adhesions

  2 months after surgery

Secondary Outcomes (2)

• Pregnancy rate

  1 year after the patient desire for pregnancy

• Menstrual improvement rate

  2 months after surgery

Study Arms (2)

Cold knife

EXPERIMENTAL

The interference of the experimental group is to perform intrauterine adhesiolysis with scissors

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.

Procedure: hot knife

Interventions

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.

Cold knife

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.

Hot knife

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fu Xing Hospital, Capital Medical University: lead

Study Sites (1)

Fu Xing Hospital, Capital Medical University

Beijing, 100038, China

RECRUITING

Related Publications (6)

• 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.

  PMID: 28603474 BACKGROUND

• 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.

  PMID: 30713131 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.

  PMID: 3381869 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.

  PMID: 18406834 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.

  PMID: 29024798 BACKGROUND

• 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.

  PMID: 24082042 RESULT

MeSH Terms

Conditions

Gynatresia

Interventions

Conization

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Tinchiu Li

  Fuxing Hospital,Capital Medical University

  STUDY CHAIR

Central Study Contacts

Xiaowu Huang

CONTACT

+8613810828816; hxiaowu_fxyy@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of department

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: June 23, 2021
• Study Start: August 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: August 31, 2022
• Last Updated: September 21, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)