Total Extraperitoneal Approach in Orthopedic Surgery

NCT06634082 | Completed

• 1 other identifier: 2023/299
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Pubic Symphysis Diastasis

Keywords

pubic symphysis diastasis; pelvic ring injury; orthopedic total extraperitoneal approach (O-TEP); endoscopy

Outcome Measures

Primary Outcomes (2)

• Operating Time

  Time taken to complete the surgical procedure.

  24 hours (after surgical procedure)

• Intraoperative Blood Loss

  Amount of blood lost during the surgical procedure.

  24 hours (after surgical procedure)

Secondary Outcomes (3)

• Postoperative Pain (VAS Scores)

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

• Hospital Stay Duration

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

• Complications

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

Study Arms (1)

O-TEP Symphysial Plating Cohort

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study population consists of patients aged 18-65 years who were diagnosed with pubic symphysis diastasis (PSD) and underwent total extraperitoneal endoscopic symphysial plating (O-TEP) at a Level 1 trauma center between March 2022 and May 2024. Patients included had a minimum follow-up period of 12 months and provided informed consent for the procedure and study participation.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

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

Istanbul, 34147, Turkey (Türkiye)

Location

Related Publications (3)

• Wake BL, McCormack K, Fraser C, Vale L, Perez J, Grant AM. Transabdominal pre-peritoneal (TAPP) vs totally extraperitoneal (TEP) laparoscopic techniques for inguinal hernia repair. Cochrane Database Syst Rev. 2005 Jan 25;2005(1):CD004703. doi: 10.1002/14651858.CD004703.pub2.

  PMID: 15674961 BACKGROUND

• Ozturk V, Bilgili MG. Combining Innovative Techniques: Total Extraperitoneal Approach in Orthopedic Surgery (O-TEP) and Percutaneous Both Column Screw (BCS) Fixation Technique in a Geriatric Acetabular Fracture Case. Z Orthop Unfall. 2025 Aug;163(4):361-367. doi: 10.1055/a-2370-0086. Epub 2024 Aug 13.

  PMID: 39137893 BACKGROUND

• Vinet M, Moullac D, David G, Segalen T, Lucas C, Dubrana F, Letissier H, Di Francia R. Laparoscopic treatment of fourteen cases of pelvic ring disruption: a case series. Int Orthop. 2024 Jul;48(7):1859-1869. doi: 10.1007/s00264-024-06170-z. Epub 2024 Apr 18.

  PMID: 38634937 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Pubic Symphysis Diastasis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Doctor in Orthopedics and Traumatology

Study Record Dates

• First Submitted: October 6, 2024
• First Posted: October 9, 2024
• Study Start: March 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

TU (1)