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
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Dabao MD
- Telefonnummer: 13017386201
- E-post: forxudabao@126.com
Studiesteder
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Hunan
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Changsha, Hunan, Kina, 410013
- Rekruttering
- The Third XIANGYA Hospital of Central South University
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Ta kontakt med:
- Dabao MD
- Telefonnummer: 13017386201
- E-post: forxudabao@126.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Experimental group
Uterine stent placement in the uterine cavity after hysteroscopic intrauterine adhesion separation surgery
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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.
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Eksperimentell: Control group
Uterine cavity insertion ring + balloon + sodium hyaluronate gel
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Intrauterine adhesion rate
Tidsramme: At 12 months after the index hysterectomy
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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%.
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At 12 months after the index hysterectomy
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- XY3-QX-ZGZ-1711A02
Legemiddel- og utstyrsinformasjon, studiedokumenter
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