- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07706062
Total Lower Uterine Segmentectomy With Adjunctive Mechanical Towel Compression for the Surgical Management of Placenta Accreta Spectrum Disorders
Total Lower Uterine Segmentectomy With Adjunctive Mechanical Towel Compression for the Surgical Management of Placenta Accreta Spectrum Disorders: A Case Series
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Placenta accreta spectrum (PAS) disorders, characterized by abnormal trophoblastic invasion into the myometrium, have seen a global rise in incidence primarily driven by increasing cesarean delivery rates. Massive obstetric hemorrhage remains the leading cause of maternal morbidity and mortality in these cases.
While cesarean hysterectomy is the traditional gold standard for severe PAS, uteruspreserving procedures are increasingly preferred by patients desiring future fertility. Total lower uterine segmentectomy with cervico-corporeal anastomosis (TLS-CCA) is a recognized conservative technique that involves excising the invaded lower segment and reconstructing the uterus. Despite removing the primary placental implantation site, diffuse bleeding from the highly vascularized remaining myometrial bed, dissected bladder flap, and pelvic collateral vessels often persists. While traditional compression sutures or specialized devices are utilized for hemostasis, they can be costly or technically challenging in distorted anatomies. This study introduces a novel, simple, and cost-effective approach: the use of tightly rolled sterile surgical towelsapplied as direct mechanical compression against the lower uterine segment and bladder bed during dissection and reconstruction.
Undersøgelsestype
Tilmelding (Anslået)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Maternal age 18-45 years
- Singleton pregnancy
- Antenatal diagnosis of PAS (ultrasound ± MRI)
- Planned elective cesarean delivery
- Candidate for uterine preservation via TLS-CCA
- Provided written informed consent
Exclusion Criteria:
- Hemodynamic instability necessitating emergency hysterectomy
- Placental invasion into adjacent pelvic organs requiring exenteration
- Pre-existing severe coagulation disorders
- Multiple gestation or major fetal anomalies
- Patient refusal to participate
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Estimated intraoperative blood loss
Tidsramme: at operation
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Estimated intraoperative blood loss by (mL)
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at operation
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Blood transfusion requirements
Tidsramme: intraoperative
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Blood transfusion requirements (units of packed RBCs and FFP)
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intraoperative
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Nourhan
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