Clinical trial NCT06634082: Total Extraperitoneal Approach in Orthopedic Surgery
Official title: Total Extraperitoneal Approach in Orthopedic Surgery (O-TEP); Preliminary Clinical Outcomes of Symphysial Plating in Fifteen Cases: A Case Series'
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pubic Symphysis Diastasis
Keywords: pubic symphysis diastasis
pelvic ring injury
orthopedic total extraperitoneal approach (O-TEP)
endoscopy
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2024-10-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Operating Time
timeFrame: 24 hours (after surgical procedure)
measure: Intraoperative Blood Loss
timeFrame: 24 hours (after surgical procedure)
Secondary outcomes:
measure: Postoperative Pain (VAS Scores)
timeFrame: until the final follow-up (12 to 25 months)
measure: Hospital Stay Duration
timeFrame: From the day of surgery until discharge (typically 2 to 4 days). Unit of Measure: Days
measure: Complications
timeFrame: From the day of surgery until the final follow-up (12 to 25 months). Unit of Measure: Number of patients with complications.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakırköy Dr. Sadi Konuk Training and Research Hospital, Department of Orthopedics and Traumatology
Study officials:
References:
citation: 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.
citation: 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. 2024 Aug 13. doi: 10.1055/a-2370-0086. Online ahead of print.
citation: 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.