Impact of Vertical vs. Transverse Closure on Outcomes of Laparoscopic Correction of Isthmocele
Laparoscopic repair of Isthmocele aims to restore the anatomical integrity and physiological function of the lower uterine segment.
- Vertical Closure: This technique involves closing the defect along the longitudinal axis of the uterus. Proponents suggest it may be more anatomically aligned with the muscle fibers of the lower uterine segment, potentially leading to stronger scar formation and reduced tension.
- Transverse Closure: This technique involves closing the defect perpendicular to the long axis of the uterus. This approach is more commonly used during primary cesarean sections.
Arguments for transverse closure in isthmocele repair include familiarity for surgeons and potentially less shortening of the lower uterine segment.
However, the actual impact of these different closure methods on long-term outcomes such as defect recurrence, scar integrity, and fertility, remains largely unexplored in a randomized controlled trial setting.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Isthmocele, also known as a cesarean scar defect (CSD), is a common complication following cesarean section, characterized by a myometrial defect at the site of the hysterotomy scar. It can lead to various symptoms including abnormal uterine bleeding, dysmenorrhea, pelvic pain, and infertility.
Laparoscopic repair aims to restore the anatomical integrity and physiological function of the lower uterine segment.
- Vertical Closure: This technique involves closing the defect along the longitudinal axis of the uterus. Proponents suggest it may be more anatomically aligned with the muscle fibers of the lower uterine segment, potentially leading to stronger scar formation and reduced tension.
- Transverse Closure: This technique involves closing the defect perpendicular to the long axis of the uterus. This approach is more commonly used during primary cesarean sections.
Arguments for transverse closure in isthmocele repair include familiarity for surgeons and potentially less shortening of the lower uterine segment.
However, the actual impact of these different closure methods on long-term outcomes such as defect recurrence, scar integrity, and fertility, remains largely unexplored in a randomized controlled trial setting.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Women aged 18-45 years.
- Diagnosis of symptomatic isthmocele confirmed by transvaginal ultrasound (myometrial thickness at the defect < 2.5 mm).
- History of at least one prior cesarean section.
- Symptoms attributable to isthmocele (e.g., abnormal uterine bleeding, pelvic pain, dysmenorrhea, secondary infertility).
- Desire for surgical correction of isthmocele.
- Ability to understand and provide informed consent
Exclusion Criteria:
- Asymptomatic isthmocele.
- Active pelvic infection or malignancy.
- Significant medical comorbidities contraindicating laparoscopic surgery.
- Coagulopathy.
- Known uterine anomalies (e.g., bicornuate uterus).
- Pregnancy at the time of recruitment.
- Inability to comply with follow-up protocol.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: Vertical Closure Group
The hysterotomy defect will be closed in two layers using interrupted or continuous sutures along the longitudinal axis of the uterus
|
The hysterotomy defect will be closed in two layers using interrupted or continuous sutures along the longitudinal axis of the uterus
|
|
Actieve vergelijker: Transverse Closure Group
The hysterotomy defect will be closed in two layers using interrupted or continuous sutures perpendicular to the longitudinal axis of the uterus
|
The hysterotomy defect will be closed in two layers using interrupted or continuous sutures perpendicular to the longitudinal axis of the uterus
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Postoperative lower uterine segment scar thickness
Tijdsspanne: 6 and 12 months post-surgery using transvaginal ultrasound
|
To evaluate the thickness of the lower uterine segment scar at 6 and 12 months post-surgery using transvaginal ultrasound
|
6 and 12 months post-surgery using transvaginal ultrasound
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
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
Andere studie-ID-nummers
- 1704-9-2025
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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Klinische onderzoeken op Vertical Closure
-
Second Affiliated Hospital, School of Medicine,...Voltooid
-
Vanderbilt University Medical CenterVoltooidThoraxinsufficiëntiesyndroom (TIS)Verenigde Staten
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University Hospital, BrestVoltooidBlessures aan de voorste kruisbandFrankrijk