The Role of Vascular Reconstruction in the Setting of Pelvic Exenteration

NCT04948879 | Unknown

• 1 other identifier: PelvEx 6
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Local invasion or abutment of a major vascular structure was once a major deterrent to planned oncological resection. Improvements in radiological assessment and vascular surgical techniques have enabled resection of major blood vessels where focally involved. However, most of this has been conducted in the context of cancers of sarcomatous, hepaticopancreaticobilary or otolaryngological origin, with little evidence detailing the experience in the context of pelvic malignancy. The aim of this retrospective review is to examine the indications for, techniques used and surgical outcomes of vascular reconstruction in the setting of pelvic exenterative surgery.

Conditions

Vascular Reconstruction in Pelvic Exenterative Surgery

Outcome Measures

Primary Outcomes (1)

• Morbidity

  Post-operative complications (\<30 days), as measured by the Clavien-Dindo scale

  July 2016 - July 2021

Secondary Outcomes (5)

• Blood loss

  July 2016 - July 2021

• Length of stay

  July 2016 - July 2021

• Graft patency/function

  July 2016 - July 2021

• Resection status

  July 2016 - July 2021

• Mortality

  July 2016 - July 2021

Study Arms (1)

Vascular reconstruction

Patients who have undergone resection with or without reconstruction of a major blood vessel in the context of surgery for a locally advanced pelvic malignancy. This will mostly refer to patients who have had resection/reconstruction of their internal iliac vessels, or less likely common iliacs.

Procedure: Vascular resection/reconstruction

Interventions

Vascular resection/reconstruction PROCEDURE

The resection of a major blood vessel with or without reconstruction

Vascular reconstruction

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 over the age of 18 years who undergo resection/reconstruction of a major blood vessel as part of pelvic exenteration for a locally advanced or recurrent pelvic (rectal, urological, gynaecological, sarcomatous) malignancy.

You may qualify if:

• Histologically proven locally advanced or recurrent pelvic cancer (all subtypes, RECTAL, UROLOGICAL, GYNAE, SARCOMA)
• Aged over 18 years
• Undergoing a multi-visceral extended pelvic resection
• Requiring a vascular resection with or without the need for reconstruction as part of pelvic exenteration

You may not qualify if:

• Strong evidence of metastatic or peritoneal disease
• No histological evidence of vascular structures resected at time of operation
• Insufficient patient follow-up (Minimum of 30 days)
• Insufficient information on post-operative follow-up of graft patency/function

Sponsors & Collaborators

• St Vincent's University Hospital, Ireland: lead

MeSH Terms

Interventions

Plastic Surgery Procedures

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Desmond Winter, MD

  St. Vincent's Healthcare Group

  STUDY CHAIR

Central Study Contacts

Matthew Fahy, MB

CONTACT

00353874510237; mfahy94@gmail.com

Michael Kelly, MD

CONTACT

kellym11@tcd.ie

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Des C Winter

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: July 2, 2021
• Study Start: August 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: January 1, 2022
• Last Updated: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share