Total Extraperitoneal Approach in Orthopedic Surgery

NCT ID: NCT06634082

Last Updated: 2024-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-01

Study Completion Date

2024-06-30

Brief Summary

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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

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Conditions

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Pubic Symphysis Diastasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bakirkoy Dr. Sadi Konuk Research and Training Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Vedat Öztürk

Specialist Doctor in Orthopedics and Traumatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 15674961 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39137893 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38634937 (View on PubMed)

Related Links

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Other Identifiers

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2023/299

Identifier Type: -

Identifier Source: org_study_id

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