To Evaluate the Safety and Effectiveness of Intrauterine Adhesion Preventer in the Prevention and Treatment of Intrauterine Adhesions, a Prospective, Multicenter, Randomized Controlled Clinical Trial

Обзор

To evaluate the effect of uterine stents in preventing intrauterine adhesions after intrauterine operation and whether they meet the safety requirements for clinical use. The trial adopted a prospective, multicenter, randomized controlled, non-inferiority clinical trial design. The target population of the trial was 200 women aged 20-40 years with intrauterine adhesions and surgical indications (referring to those with fertility requirements or menstrual blood drainage obstruction), who were randomly divided into an experimental group and a control group, with 100 cases in each group. The experimental group was the group with intrauterine stents placed in the uterine cavity after hysteroscopic intrauterine adhesion separation surgery, and the control group was the group with intrauterine rings + balloons + sodium hyaluronate gel placed in the uterine cavity. After 3 courses of artificial cycles, the patients were hospitalized for hysteroscopy review.

Вмешательства

• Устройство Uterine stent group
  After TCRA, uterine stents of different specifications were placed in the uterine cavity according to the different uterine cavity morphologies of the subjects, and the hysteroscope was inserted again to adjust the position of the uterine stent.
• Устройство Uterine ring + balloon + sodium hyaluronate gel
  The subjects were hospitalized for TCRA surgery. After the surgery, different types of uterine rings were selected and inserted into the uterine cavity according to the morphology of the subjects' uterine cavity. At the same time, a No. 12 Foley catheter was left in the uterine cavity, and 2.5 ml of normal saline was injected into the catheter balloon. 2 ml of hyaluronic acid gel was injected into the uterine cavity on one side of the catheter. The doctor removed the Foley catheter on the first

Первичные конечные точки

• Intrauterine adhesion rate [Срок оценки: At 12 months after the index hysterectomy]

Критерии участия

Критерии включения

• Patients clinically diagnosed with intrauterine adhesions and with surgical indications (referring to those with fertility requirements or obstructed menstrual blood drainage) ② Women aged 20-40 years old; ③ Subjects voluntarily participated in the trial and signed informed consent.

Критерии исключения

• ① Patients with obviously abnormal uterine cavity shape after surgery; those who could not clearly separate the normal uterine cavity anatomical morphology (i.e. bilateral or unilateral fallopian tube openings were not visible); those with reproductive organ malformations and uterine cavities that were too large or too small; those with recent uterine perforation; those with cervical insufficiency.

• Those with a history of intrauterine adhesions and treatment;

• Those with endometrial tuberculosis or suspected endometrial tuberculosis;

• Those with adenomyosis or uterine fibroids>4cm;

• Those with a history of malignant tumors or suspected malignant tumors;

• Those with acute and chronic intrauterine infection and genital infection;

• Those with unexplained vaginal bleeding or suspected uterine malignant lesions;

• Those with severe anemia and abnormal coagulation function; those with a history of thrombosis; ⑨ Those in the acute stage of various diseases or severe systemic diseases;

• Those with severe mental illness and physical weakness who cannot tolerate this operation;

⑪ Those with severe heart, liver, and kidney function diseases;

⑫ Those with contraindications to anesthesia or surgery;

⑬ Those who have participated in clinical trials in the past three months.

• Those who are considered unsuitable for inclusion by the researchers.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• The Third Xiangya Hospital of Central South University — Чанша

Идентификаторы

NCT: NCT07611474 · XY3-QX-ZGZ-1711A02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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