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Total Extraperitoneal Approach in Orthopedic Surgery

B

Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Status

Completed

Conditions

Pubic Symphysis Diastasis

Study type

Observational

Funder types

Other

Identifiers

NCT06634082
2023/299

Details and patient eligibility

About

The goal of this retrospective observational study is to evaluate the preliminary clinical and functional outcomes of total extraperitoneal approach (O-TEP) symphysial plating in patients with pubic symphysis diastasis (PSD). The study involved 15 patients (90% male, mean age 40) treated between March 2022 and May 2024.

The main questions it aims to answer are:

What are the clinical outcomes (e.g., VAS scores, Iowa Pelvic Scores, Majeed scores) following O-TEP symphysial plating? What are the surgical outcomes, including operating time, blood loss, and complications, associated with this minimally invasive technique?

Participants underwent:

Total extraperitoneal endoscopic symphysial plating, with follow-up assessments including postoperative pain scores, radiographs, and functional outcome evaluations using the Iowa Pelvic and Majeed scores.

Researchers will analyze the outcomes to see if this approach offers advantages over traditional open surgery, potentially reducing complications and improving recovery in PSD patients.

Enrollment

15 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients diagnosed with pubic symphysis diastasis (PSD).
  • Patients who underwent total extraperitoneal endoscopic symphysial plating (O-TEP) between March 2022 and May 2024.
  • Patients with a follow-up period of at least 12 months.
  • Patients who provided informed consent for the surgical procedure and the study.

Exclusion criteria

  • Patients who required conversion to open surgery during the procedure (e.g., due to pneumoperitoneum).
  • Patients with a follow-up period of less than 12 months.
  • Patients with incomplete clinical or radiological data.
  • Patients with contraindications to endoscopic surgery.
  • Patients who did not provide informed consent for the study.

Trial design

15 participants in 1 patient group

O-TEP Symphysial Plating Cohort
Description:
This cohort consists of 15 patients with pubic symphysis diastasis (PSD) who underwent total extraperitoneal endoscopic symphysial plating (O-TEP) between March 2022 and May 2024. The interventions include a minimally invasive plating procedure aimed at evaluating clinical outcomes, such as postoperative pain, functional recovery, and complications

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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