Clinical and Basic Research on the Necessity of Scar Tissue Resection During Intrauterine Adhesions

NCT ID: NCT05003869

Last Updated: 2021-09-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-25
• Study Completion Date: 2024-05-31

Brief Summary

TCRA is an important surgical method to restore normal menstrual cycle and improve the outcome of pregnancy.However, postoperative intrauterine adhesion, uterine cavity deformation and difficulty in normal intimal growth seriously affect the efficacy of surgery. A large number of existing studies have shown that even after surgical treatment, women with a history of IUA are still at a reproductive disadvantage.Whether scar tissue plays a role in these influencing factors? At present, there is a variety of surgical methods, and there is no clear guideline consensus on how to deal with intrauterine scar tissue during surgery.

Detailed Description

Intrauterine adhesions (IUA) are pathological symptoms of endometrial basal layer damage, fibrous tissue formation and tissue bridge between uterine walls caused by a variety of reasons.In recent years, with the increase of uterine operations such as hysterotomy and cesarean section, the incidence of IUA has been increasing year by year.IUA is mainly manifested by reduced menstrual volume, amenorrhea, recurrent abortion, infertility and abnormal implantation of embryos, etc., which poses a great threat to the health and quality of life of patients.Transcervieal resection of adhesions (TCRA) is a targeted method to separate intrauterine adhesions under direct vision and basically restore the morphology of the intrauterine cavity. It is an important surgical method to improve the pregnancy outcome.However, a large number of existing studies have shown that women with a history of IUA remain at a reproductive disadvantage even after surgical treatment.

Based on the current situation, the investigators have designed this topic, to conduct a study on TCRA intraoperative scar tissue to remove the necessity of clinical and basic research, explore the scar tissue resection or not for the clinical curative effect and the effect of combined tissue morphology, molecular biology research, for TCRA intraoperative how to deal with the scar tissue provide a certain amount of practice and theory basis.

Estrogen receptor (e-r) and progesterone receptor (P - R) is located in the nucleus, when the receptor and hormones to form complexes, again in the form of activation combined into specific areas of the chromosome, gene activation, synthesis of new DNA transcription, and synthesis of new proteins, through the biological function of protein regulating cell growth and metabolism.Specifically, they participate in the reconstruction and regeneration of endometrial blood vessels and cells.The number and functional status of hormone receptors determine the local levels of estrogen and progesterone that can exert biological effects. If the expression of E-R and P-R is reduced or the function is abnormal, the sensitivity and reactivity of endometrium to hormones will be directly reduced, and the endometrial growth will be affected.

The treatment of IUA is mainly based on direct separation of the adhesive tissue, supplemented by the corresponding hormone or cytokine therapy.Among them, estrogen is widely used.On the one hand, it plays a corresponding role by binding with receptors; on the other hand, it affects the fibrinogen and extracellular matrix deposition by regulating the expression of TGF-β or MMP-9, thus participating in the occurrence of intrauterine adhesions.

Studies have found that there is a certain correlation between transforming growth factor-β1 (TGF-β1) and the pathogenesis of IUA. TGF-β1 is a kind of cytokine that is synthesized and secreted by lymphocytes, macrophages, platelets and other cells and can regulate cell growth and differentiation, belonging to the TGF family.It can promote tissue fibrosis and extracellular matrix production, and can increase the amount of fibronectin and collagen.However, a number of studies have confirmed that inhibiting the expression of TGF-β1 or reducing its activity can effectively reduce the degree of fibrosis in liver, kidney and other tissues.

Conditions

Intrauterine Adhesion; Scar

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intraoperative resection of intrauterine scar tissue by TCRA

Study group: patients took the bladder lithotomy position, routinely disinfected vulva and vagina, and laid sterile towel and sheet.pliers Clamp the front lip of the cervix, explore the depth of the uterine cavity, dilate the cervical canal one by one, place the endoscopy, and examine the uterine cavity.After the scar tissue contracted on one side, the scar tissue was disintegrated at the boundary between the intima and scar tissue. The scar tissue was removed with the annular electrode, and a balloon was placed after surgery to prevent re-adhesion.Complete adhesion release is defined as a return to normal shape of the uterine cavity with bilateral uterine angles exposed.

Group Type: EXPERIMENTAL

Scar tissue is removed

Intervention Type: PROCEDURE

The patients were divided into two groups according to whether the scar tissue was removed during TCRA operation: study group: resection of uterine scar tissue during TCRA operation;In the control group, the scar tissue covering the anterior, posterior and lateral walls of the uterine cavity was ploughed longitudinally into several narrow strips using needle-like electrodes, and the scar tissue was not excised.

No scar tissue resection group

During the operation, the scar tissue covering the anterior, posterior and lateral walls of the uterine cavity was ploughed longitudinally into several narrow strips with needle-like electrodes, and scar tissue was not excised.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Scar tissue is removed

The patients were divided into two groups according to whether the scar tissue was removed during TCRA operation: study group: resection of uterine scar tissue during TCRA operation;In the control group, the scar tissue covering the anterior, posterior and lateral walls of the uterine cavity was ploughed longitudinally into several narrow strips using needle-like electrodes, and the scar tissue was not excised.

Intervention Type: PROCEDURE

Other Intervention Names

No scar tissue is removed

Eligibility Criteria

Inclusion Criteria

1. Consensus of Chinese Experts on the Clinical Diagnosis and Treatment of Intrauterine Adhesions, i.e., patients with previous history of induced abortion and other intrauterine operations, accompanied by periodical abdominal pain, fewmenorrhea, amenorrhea, recurrent abortion, infertility, and uterine adhesions found by hysteroscopy, who have fertility requirements;

2. According to the American Reproductive Society prognostic classification, the AFS score was moderate to severe intrauterine adhesions, that is, the score range was 5-12 points;

3. Patients ranged in age from 18 to 42 years old;

4. normal endocrine function and ovulation;

5. Patients had comprehensive clinical data and were followed up after surgery.

Exclusion Criteria

1. Patients with severe cardiovascular and cerebrovascular diseases, liver and kidney dysfunction and other systemic diseases;

2. Patients who recently received female genital surgery or underwent high uterine flexion and were unable to receive hysteroscopy and surgical treatment;

3. Amenorrhea, recurrent abortion and infertility caused by other factors such as neuro-endocrine system disorders or congenital abnormalities of reproductive structure and development;

4. Patients with allergic reaction to estrogen and other drugs;

5. Severe abnormal semen of the spouse.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Lili Cao

OTHER

Sponsor Role: lead

Responsible Party

Lili Cao

Shandong Qianfoshan Hospital Scientific Research Department Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yingchun Ma, Doctor

Role: STUDY_CHAIR

Shandong First Medical University

Locations

China, Shandong Qianfoshan Hospital

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lili Cao

Role: CONTACT

qykyc309@163.com

89269891

Facility Contacts

Lili Cao

Role: primary

qykyc309@163.com

Other Identifiers

QCT042806

Identifier Type: -

Identifier Source: org_study_id