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

NCT05003869 | Unknown

• 1 other identifier: QCT042806
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Intrauterine Adhesion; Scar

Outcome Measures

Primary Outcomes (3)

• The menstrual chart records changes in menstrual volume

  Menstrual chart records the amount of menstruation before and after surgery:Menstrual volume is basically normal;Menstrual volume increased compared with preoperative;Still amenorrhea or menstrual volume is not increased

  1 to 3 months before surgery and the first month after the operation

• Preoperative and postoperative changes in endometrial thickness were recorded by Doppler ultrasonography.

  Ultrasound was used to record endometrial thickness before and 2 weeks after the first operation. The second hysteroscopy was performed 3-7 days after the first clean menstruation after the first operation, and ultrasound was performed again 2 weeks after the operation to record the data and compare the endometrial thickness of each group.

  Ultrasound examinations were performed before and 2 weeks after the first operation, and 2 weeks after the second operation

• Preoperative and postoperative changes of intrauterine adhesions were recorded according to the American Fertility Society score in 1988: mild :1 ~ 4; Moderate: 5-8; Severe: 9-12 points

  The operation time was within 3-7 days after menstruation (surgery could be performed at any time after excluding pregnancy for amenorrhea). Preoperative hysteroscopy scores and surgical procedures were all performed by the same surgeon.Intrauterine adhesions were measured using the 1988 American Fertility Society (AFS) score. Three to seven days after the first menstrual cleanness, the patient was admitted to the hospital for hysteroscopic reexamination. During hysteroscopy, the intrauterine adhesion and intimal recovery of the patient were explored.

  The first operation time is 3-7 days after menstruation (excluding amenorrhea pregnancy can be operated at any time). The second operation was performed 1 month after the first operation

Secondary Outcomes (1)

• Ultrasound of uterine adnexa was used to record the intrauterine pregnancy

  The pregnancy of the patients was followed up by telephone three months after surgery for at least 1 year, and the clinical pregnancy rate was recorded.

Study Arms (2)

Intraoperative resection of intrauterine scar tissue by TCRA

EXPERIMENTAL

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.

Procedure: Scar tissue is removed

No scar tissue resection group

NO INTERVENTION

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.

Interventions

Scar tissue is removed 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.

Also known as: No scar tissue is removed

Intraoperative resection of intrauterine scar tissue by TCRA

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• 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;
• Patients ranged in age from 18 to 42 years old;
• normal endocrine function and ovulation;
• Patients had comprehensive clinical data and were followed up after surgery.

You may not qualify if:

• Patients with severe cardiovascular and cerebrovascular diseases, liver and kidney dysfunction and other systemic diseases;
• Patients who recently received female genital surgery or underwent high uterine flexion and were unable to receive hysteroscopy and surgical treatment;
• Amenorrhea, recurrent abortion and infertility caused by other factors such as neuro-endocrine system disorders or congenital abnormalities of reproductive structure and development;
• Patients with allergic reaction to estrogen and other drugs;
• Severe abnormal semen of the spouse.

Sponsors & Collaborators

• Lili Cao: lead

Study Sites (1)

China, Shandong Qianfoshan Hospital

Jinan, Shandong, 250014, China

RECRUITING

MeSH Terms

Conditions

Gynatresia; Cicatrix

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yingchun Ma, Doctor

  Shandong First Medical University

  STUDY CHAIR

Central Study Contacts

Lili Cao

CONTACT

89269891; qykyc309@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Shandong Qianfoshan Hospital Scientific Research Department Director

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: August 13, 2021
• Study Start: May 25, 2021
• Primary Completion: March 31, 2024
• Study Completion: May 31, 2024
• Last Updated: September 9, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)