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

February 12, 2024 updated by: Cemre Alan, Necmettin Erbakan University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

81

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Konya, Turkey
        • Cemre Alan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pregnant women who underwent surgery for PAS and bladder invasion between January 2018 and January 2023 in a tertiary university hospital in Turkey.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bladder suture group
This group consisted of patients in whom we could not open the bladder and uterine cervix by dissection, so we had to open the bladder. In this group, the bladder dome was opened and a special suture was passed through the bladder to control bleeding. This procedure was performed to control bleeding.
Procedure: ACAR-Style Bladder Suture
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.
Control group
For the patients in this group, the vascular structures between the bladder and cervix were coagulated one by one. The bladder was not opened during this procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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(%).
during operation time
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)
postoperative three days,
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.
six months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Necmettin Erbakan University

Investigators

  • Study Director: Ali Acar, MD
  • Principal Investigator: Şükran Doğru, MD
  • Study Chair: Fatih Akkuş, MD
  • Study Chair: Cemre Alan, MD
  • Study Chair: Fikriye Karanfil Yaman, MD
  • Study Chair: Huriye Ezveci, MD
  • Study Chair: Orhan Ay, MD
  • Study Chair: Fethiye Şahin, MD
  • Study Chair: Burçin Elaziz, MD
  • Study Chair: Meryem Gümüş, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

January 1, 2024

Study Registration Dates

First Submitted

January 15, 2024

First Submitted That Met QC Criteria

February 12, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACAR-Style Bladder Suture

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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