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NCT Number: NCT06634082

Total Extraperitoneal Approach in Orthopedic Surgery

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.

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Key information

Conditions

Pubic Symphysis Diastasis Diastasis, Bone Female Urogenital Diseases and Pregnancy Complications Joint Diseases Joint Dislocations Musculoskeletal Diseases Pregnancy Complications Puerperal Disorders Urogenital Diseases Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bakırköy Dr. Sadi Konuk Training and Research Hospital, Department of Orthopedics and Traumatology

Istanbul, 34147, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. Operating Time

    Time frame: 24 hours (after surgical procedure)

    Time taken to complete the surgical procedure.

  2. Intraoperative Blood Loss

    Time frame: 24 hours (after surgical procedure)

    Amount of blood lost during the surgical procedure.

Secondary outcomes

  1. Postoperative Pain (VAS Scores)

    Time frame: until the final follow-up (12 to 25 months)

    The VAS is scored from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain.

  2. Hospital Stay Duration

    Time frame: From the day of surgery until discharge (typically 2 to 4 days). Unit of Measure: Days

    The total number of days the patient stays in the hospital from the day of surgery until discharge.

  3. Complications

    Time frame: From the day of surgery until the final follow-up (12 to 25 months). Unit of Measure: Number of patients with complications.

    Any postoperative complications, including infection, implant failure, or the need for revision surgery.

Sponsors and collaborators

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Other Gov

Registry information

Official study title

Total Extraperitoneal Approach in Orthopedic Surgery (O-TEP); Preliminary Clinical Outcomes of Symphysial Plating in Fifteen Cases: A Case Series'

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 9, 2024
Registry last updated
Oct 9, 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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