Pubic Symphysis DiastasisNCT06634082
Total Extraperitoneal Approach in Orthopedic Surgery
An observational study of Pubic Symphysis Diastasis, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pubic Symphysis Diastasis
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakırköy Dr. Sadi Konuk Training and Research Hospital, Department of Orthopedics and Traumatology
Istanbul, 34147
About this study
Official title: Total Extraperitoneal Approach in Orthopedic Surgery (O-TEP); Preliminary Clinical Outcomes of Symphysial Plating in Fifteen Cases: A Case Series'
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:
Read more
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
- Medical subject headings
- Pubic Symphysis Diastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operating Time
Time taken to complete the surgical procedure.
Measured: 24 hours (after surgical procedure)
Intraoperative Blood Loss
Amount of blood lost during the surgical procedure.
Measured: 24 hours (after surgical procedure)
Secondary outcomes (3)
Postoperative Pain (VAS Scores)
The VAS is scored from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain.
Measured: until the final follow-up (12 to 25 months)
Hospital Stay Duration
The total number of days the patient stays in the hospital from the day of surgery until discharge.
Measured: From the day of surgery until discharge (typically 2 to 4 days). Unit of Measure: Days
Complications
Any postoperative complications, including infection, implant failure, or the need for revision surgery.
Measured: From the day of surgery until the final follow-up (12 to 25 months). Unit of Measure: Number of patients with complications.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start1 Mar 2022
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pubic Symphysis DiastasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Vedat Öztürk, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634082
- Sponsor's protocol ID
- 2023/299
- Status last verified
- Oct 2024
- First submitted
- 6 Oct 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 15674961Ozturk 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.
PubMed 39137893Vinet 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.
PubMed 38634937
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Extraperitoneal Approach in Orthopedic Surgery (O-TEP); Preliminary Clinical Outcomes of Symphysial Plating in Fifteen Cases: A Case Series'
- ClinicalTrials.gov ID
- NCT06634082
- Acronym / sponsor ID
- 2023/299
- Conditions
- Pubic Symphysis Diastasis
- Keywords
- pubic symphysis diastasis, pelvic ring injury, orthopedic total extraperitoneal approach (O-TEP), endoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Operating Time
Time frame: 24 hours (after surgical procedure)
Time taken to complete the surgical procedure.
Intraoperative Blood Loss
Time frame: 24 hours (after surgical procedure)
Amount of blood lost during the surgical procedure.
3 secondary outcomes
Postoperative Pain (VAS Scores)
Time frame: until the final follow-up (12 to 25 months)
Hospital Stay Duration
Time frame: From the day of surgery until discharge (typically 2 to 4 days). Unit of Measure: Days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Background: PubMed 15674961Wake 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.
- Background: PubMed 39137893Ozturk 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.
- Background: PubMed 38634937Vinet 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Pubic Symphysis Diastasis
Recruiting
Effects of Pelvic Floor Exercises and Pelvic Support Belt in Symphysis Pubis Dysfunction
Pubic Symphysis Diastasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pubic Symphysis Diastasis, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operating Time (time frame: 24 hours (after surgical procedure)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06634082, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.