Pelvic Exenteration and Laterally Extended Pelvic Resection

NCT06278610 | Recruiting

• 1 other identifier: 3612
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

Growing evidence in literature is supporting the role of ultrasound scan (US) as accurate tool in diagnosis and staging of gynecologic cancers. In particular, different studies demonstrated the accuracy of US in assessing endometrial, cervical, and ovarian cancer in the primary setting. However, the number of studies investigating the role of US in the recurrent setting is limited. Moreover, there is no evidence in literature exploring the role of US in laterally-extended pelvic recurrences from gynecologic cancer, where the Magnetic Resonance Imaging (MRI) scan is still considered the most accurate tool.

Conditions

Gynecologic Cancer; Surgical Procedure, Unspecified

Keywords

pelvic; resection; exenteration

Outcome Measures

Primary Outcomes (1)

• pelvic exenteration resection.

  The accuracy of US in the assessment of pelvic structures involvement in recurrent/persistent gynecologic tumors with disease limited to the pelvis.

  30 minutes

Secondary Outcomes (1)

• accuracy of US with the accuracy of MRI

  1 week

Interventions

PELVIC EXENTERATION DIAGNOSTIC_TEST

PELVIC EXENTERATION

Also known as: Diagnostic Test: For example, imaging,, Procedure/Surgery

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing pelvic evisceration and lateral pelvic resection

You may qualify if:

• All consecutive patients with histologically-proven recurrent or persistent gynecological cancer who are planned to undergo pelvic exenteration or laterally extended pelvic resection, both with curative and with palliative intent.
• Anterior/total pelvic exenteration
• Laterally extended endopelvic resection (LEER)
• Laterally extended pelvic resection (LEPR) is defined as an en bloc lateral resection of a pelvic tumor involving sidewall muscle, and/or bone, and/or major nerve, and/or major vascular structure
• With or without stoma formation

You may not qualify if:

• Radical hysterectomy without lateral resection
• Rectal resection only (posterior exenteration)

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

MeSH Terms

Interventions

Diagnostic Tests, Routine; Diagnostic Imaging

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• ANTONIA CARLA TESTA, PROF

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ANTONIA CARLA TESTA, PROF

CONTACT

0630156399; antoniacarla.testa@policlinicogemelli.it

NICOLO' DR BIZZARRI

CONTACT

3471771680; nicolo.bizzarri@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: February 26, 2024
• Study Start: November 19, 2020
• Primary Completion: December 30, 2024
• Study Completion: January 31, 2025
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)