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Completed

NCT Number: NCT06267599

Bladder Suture in Uterus-Sparing Surgery and Hysterectomy for Placenta Percreta

This study aimed to evaluate the short-term and long-term complications of placenta percreta with bladder invasion. This evaluation focuses on cases where bladder dissection and ACAR-style bladder sutures were applied in cases of placenta percreta with bladder invasion that underwent uterine-sparing surgery or hysterectomy.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Cemre Alan

Konya, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women
  • Clinical diagnosis of PAS
  • PAS with bladder invasion

Exclusion criteria

  • Cases with incomplete or inadequate medical records
  • Cases with other types of placental invasion (e.g., placenta accreta, placenta increta),
  • Cases with missing key data points.

Treatment and study plan

ACAR-Style Bladder Suture

Procedure

In cases where dissection is not possible, the upper border of the bladder is opened transversely with a cutter, and the ureteral catheters and trigone inside the bladder are observed. The bladder invasion border is re-evaluated intravesically. The uterine arteries are held bilaterally with a sensitive clamp that does not crush the uterine arteries. Then, the uterus is incised from the upper border of the bladder without damaging the bladder and the predetermined myometrial invasion area is resected. After the placenta is removed, the cervical canal is found and marked with a number one vicryl suture. In these patients, the placental material is removed in pieces in the cervix area where the bladder is invaded. After the removal of the placenta, the cervix in the lower segment of the uterus is orientated and sutured together with the bladder, and this area is closed.

Primary outcomes

  1. Comparison of intraoperative bleeding and complication rates of the two groups

    Time frame: during operation time

    It was observed that the amount of intraoperative bleeding (volume aspirated cc blood), surgical time (minutes), blood transfusion rates (%), and hysterectomy rates(%).

  2. Comparison of postoperative bleeding between two groups

    Time frame: postoperative three days,

    It was observed that the amount of postoperative bleeding (hemoglobin(g/dL) change, need for blood transfusion Unite)

  3. Comparison of complication rate between two groups

    Time frame: six months postoperatively

    It was described as long-term bladder dysfunction(Nocturia, Urgency, Stress urinary incontinance, fistula rate (%))

    Nocturia: Waking up more than once during the night. Urgency: Sudden, intense urge to urinate followed by an involuntary loss of urine.

    Stress urinary incontinance: Happens when physical movement or activity - such as coughing, laughing, sneezing, running or heavy lifting - puts pressure (stress) on your bladder, causing you to leak urine.

Sponsors and collaborators

Lead sponsor

Necmettin Erbakan University

Other

Registry information

Official study title

ACAR-Style Bladder Suture in Uterus-Sparing Surgery and Hysterectomy for Placenta Percreta: A Result Analysis

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Feb 20, 2024
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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