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
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Dabao MD
- Telefoonnummer: 13017386201
- E-mail: forxudabao@126.com
Studie Locaties
-
-
Hunan
-
Changsha, Hunan, China, 410013
- Werving
- The Third XIANGYA Hospital of Central South University
-
Contact:
- Dabao MD
- Telefoonnummer: 13017386201
- E-mail: forxudabao@126.com
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- 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.
Exclusion Criteria:
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Experimental group
Uterine stent placement in the uterine cavity after hysteroscopic intrauterine adhesion separation surgery
|
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.
|
|
Experimenteel: Control group
Uterine cavity insertion 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 day after the surgery.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Intrauterine adhesion rate
Tijdsspanne: At 12 months after the index hysterectomy
|
Refer to the 2017 American Fertility Association IUA guidelines AFS score.
AFS score: The case with adhesion whose total AFS score decreased by ≥ 4 points was considered effective.
The effective rate was calculated using the following formula: number of cases with total AFS score decreased by ≥ 4 points/total number of cases × 100%.
|
At 12 months after the index hysterectomy
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- XY3-QX-ZGZ-1711A02
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .