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The Effectiveness of Double Incision Technique in Uterus Preserving Surgery for Placenta Percreta

Primary Purpose

Placenta Percreta

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Double uterine incision technique in uterus preserving surgery for placenta percreta
Sponsored by
Kanuni Sultan Suleyman Training and Research Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional trial for Placenta Percreta focused on measuring efficacy, double incision technique, uterus preserving surgery

Eligibility Criteria

18 Years - 45 Years (Adult)Female

Inclusion Criteria:

  • Intraoperatively and pathologically confirmed diagnosis of placenta percreta

Exclusion Criteria:

-

Sites / Locations

    Outcomes

    Primary Outcome Measures

    The success of segmental resection (Uterus preserving surgery)
    No need for hysterectomy due to massive hemorrhage or any other reason in postoperative one month

    Secondary Outcome Measures

    Full Information

    First Posted
    February 26, 2016
    Last Updated
    March 2, 2016
    Sponsor
    Kanuni Sultan Suleyman Training and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02702024
    Brief Title
    The Effectiveness of Double Incision Technique in Uterus Preserving Surgery for Placenta Percreta
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    January 2016 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kanuni Sultan Suleyman Training and Research Hospital

    4. Oversight

    5. Study Description

    Brief Summary
    Placenta percreta is a life-threatening condition that patients are under risk of massive bleeding. It readily necessitates very complicated surgery even leads to mortality. Cesarean hysterectomy is the procedure that is acknowledged worldwide, however, recent studies discussing conservative treatment with segmental resections were published. Fetal extraction and segmental resection could be performed from same (single uterine incision) or two different (double uterine incision) incisions. In this study, the investigators aimed to evaluate the effectiveness and the results of double uterine incision.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Placenta Percreta
    Keywords
    efficacy, double incision technique, uterus preserving surgery

    7. Study Design

    Study Phase
    Not Applicable

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    Double uterine incision technique in uterus preserving surgery for placenta percreta
    Primary Outcome Measure Information:
    Title
    The success of segmental resection (Uterus preserving surgery)
    Description
    No need for hysterectomy due to massive hemorrhage or any other reason in postoperative one month
    Time Frame
    Postoperative one month

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Eligibility Criteria
    Inclusion Criteria: Intraoperatively and pathologically confirmed diagnosis of placenta percreta Exclusion Criteria: -

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    Citations:
    PubMed Identifier
    28449642
    Citation
    Polat I, Yucel B, Gedikbasi A, Aslan H, Fendal A. The effectiveness of double incision technique in uterus preserving surgery for placenta percreta. BMC Pregnancy Childbirth. 2017 Apr 27;17(1):129. doi: 10.1186/s12884-017-1262-3.
    Results Reference
    derived

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    The Effectiveness of Double Incision Technique in Uterus Preserving Surgery for Placenta Percreta

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