Recruiting

NCT Number: NCT06803251

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

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

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Key information

Conditions

Retroperitoneal Neoplasms Abdominal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS AOU di Bologna Policlinico di Sant'Orsola

Bologna, Italia, 40138, Italy

Location status: Recruiting

Location contact

Mauro Prof Gargiulo, MD

CONTACT

[email protected]

0512143288

About this study

Very large abdominal and pelvic retroperitoneal masses frequently involve the retroperitoneal vascular structures.

Data from the literature show that after spinal surgery and orthopedic surgery, oncological surgery represents a specialist branch that frequently requires intraoperative vascular surgical assistance (6.7 - 9.6% of requests)5,6

. In these cases, the surgical assistance of the vascular surgeon allows the safe removal of the mass, the possible repair of the vessels damaged during cleavage and isolation of the mass, ligation or complete reconstruction of the vascular segment involved and contributes to reducing intraoperative and postoperative complications.

The clinical relevance of the evaluation of the short- and long-term results of the study lies in the fact that the case study it is expected to obtain greatly exceeds the few already published. Knowledge of outcomes on a larger sample will help shed light on aspects such as the need for more or less extensive surgical resection and on the choice of revascularization technique.

The primary objective of the study is to evaluate the outcomes of musculoskeletal tumor removal procedures in relation to the type of vascular surgical care provided.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Treatment and study plan

Primary outcomes

Reduction of vascular issues during the procedure

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

Numbers of major and minor vascular issues during retroperitoneal procedures.

Study contacts

Contact information is provided by the study sponsor or research team.

Mauro MG Gargiulo, MD

CONTACT

[email protected]

0512143288 ext. +39

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

Il Ruolo Del Chirurgo Vascolare Nella Chirurgia Oncologica Delle Masse Addominali E Pelviche Retroperitoneali

Acronym: IOVA-rpt

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2026
First posted: Jan 31, 2025
Registry last updated: Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed