Total Extraperitoneal Approach in Orthopedic Surgery

Completed

• Conditions: Pubic Symphysis Diastasis

• Registration Number: NCT06634082
• Lead Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-01
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Status Verified: 2024-10
• Study First Submitted: 2024-10-06
• Study First Submitted QC: 2024-10-08
• Last Update Submitted: 2024-10-08
• Study First Posted: 2024-10-09
• Last Update Posted: 2024-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Operating Time	24 hours (after surgical procedure)	Time taken to complete the surgical procedure.
Intraoperative Blood Loss	24 hours (after surgical procedure)	Amount of blood lost during the surgical procedure.

Secondary Outcome Measures

Name	Time	Method
Hospital Stay Duration	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.
Complications	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.
Postoperative Pain (VAS Scores)	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.

Trial Locations

Locations (1)

Bakırköy Dr. Sadi Konuk Training and Research Hospital, Department of Orthopedics and Traumatology; 🇹🇷 Istanbul, Turkey