NCT05003869|Unknown
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Sponsor study identifier
interventional
198
1 country
1
Study Start
May 25, 2021
Actual (reported)Primary Completion
March 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 25, 2021
Actual (reported)July 14, 2021
Actual (reported)August 13, 2021
Actual (reported)March 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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 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.
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
China, Shandong Qianfoshan Hospital
Jinan, Shandong, 250014, China
Yingchun Ma, Doctor
Shandong First Medical University
First Submitted
July 14, 2021
First Posted
August 13, 2021
Study Start
May 25, 2021
Actual (reported)Primary Completion
March 31, 2024
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 9, 2021
Record last verified: 2021-09
Personal data of participants and participants in the study will be kept confidential and will only be used for statistical analysis by the study team
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Source: ClinicalTrials.gov.
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