The Role of the Vascular Surgeon in Oncologic Surgery of Abdominal and Pelvic Retroperitoneal Masses

NCT06803251 | Recruiting

• 1 other identifier: IOVA-rpt
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Retroperitoneal tumors (RPTs - retroperitoneal tumors) are neoplasms that originate from the soft tissues of the retroperitoneum and in their more invasive forms can involve the retroperitoneal organs and large abdominal and pelvic vascular structures. They are divided into benign tumors (20%), of which teratomas and tumors of neurogenic origin are the most frequent, and malignant tumors (80%), of which the most frequent are sarcomas (RPS - retroperitoneal sarcoma)1. These are often large lesions, which can exceed 15 cm in diameter and which develop asymptomatically until the surrounding structures are involved. The initial symptoms are often represented by lumbar pain and abdominal distension which occur after multiple organ involvement. To date, the treatment of choice is surgical excision of the mass with the aim of obtaining a clean resection margin R0 (macroscopically and microscopically free of disease) or R1 (with margin only macroscopically free of disease). The most recent literature on this topic demonstrates how the treatment of RPS in specialized centers by a multidisciplinary team that works as a team and uses cutting-edge diagnostic and surgical techniques can improve the R0/R1 resection rate and overall survival. (OS)2. The rate of intra- and post-operative surgical complications increases in direct proportion to the width of the excision; however, major complications are not associated with statistically significant differences in terms of OS, local recurrence (LR) and survival in the absence of distant metastases

Conditions

Retroperitoneal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Reduction of vascular issues during the procedure

  Numbers of major and minor vascular issues during retroperitoneal procedures.

  From the first patient enrolled to the 70th patient, an average of 3 years

Eligibility Criteria

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

Study Population

Patients belonging to the UU.OO. General Surgery, Urology and Gynecological Oncology of the IRCCS University Hospital of Bologna, with diagnosis of intra-abdominal or pelvic retroperitoneal mass with involvement of vascular structures and indication for surgical treatment of removal of the mass which requires the presence of a vascular surgeon. This indication is supported by international guidelines and represents normal clinical practice in these patients.

You may qualify if:

• Patient diagnosed with a retroperitoneal mass involving the abdominal and/or pelvic vascular structures and requiring surgical removal
• Planned surgical treatment with intra-operative assistance from the vascular surgeon
• Obtaining informed consent
• Age 18 years

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS AOU di Bologna Policlinico di Sant'Orsola

Bologna, Italia, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Retroperitoneal Neoplasms

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Mauro Gargiulo, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mauro MG Gargiulo, MD

CONTACT

0512143288; mauro.gargiulo2@unibo.it

Study Design

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

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: January 31, 2025
• Study Start: July 14, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 31, 2025

Record last verified: 2024-10

Locations

IT (1)