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UnknownNCT04948762

A Contemporary Review of Surgical Approaches in Pelvic Exenterative Surgery

Status
Unknown
Phase
Study type
Observational
Enrollment
1,000 (estimated)
Sponsor
St Vincent's University Hospital, Ireland · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Minimally-invasive surgery (MIS) techniques have revolutionised the approach to rectal cancer surgery. With increasing experience, surgeons have began to utilise these platforms increasingly in the context of pelvic exenteration (PE). This observational retrospective review plans to assess the volume of PE being performed on a global basis and to assess the comparative outcomes associated with each technique in order to assess the optimal approach to radical pelvic surgery.

Detailed description

Pelvic exenteration (extended pelvic multi-visceral resection) is a radical procedure that offers potential long-term cure in appropriately selected cases of locally advanced and recurrent pelvic cancers. It was first described by Alexander Brunschwig in 1948 as a viable palliative option for advanced gynaecological cancer. However, over the last 70 years, changes in surgical oncology practices have seen its role extended to include other advanced non-gynaecological cancers (locally advanced colorectal, urological, and sarcomatous neoplasms). Although these procedures pose a significant challenge for the operating surgeon, improved surgical techniques, technology, and reconstructive options have facilitated more radical resections. Despite improved surgical options, patients still have considerable post-operative morbidity and negative impact to quality of life. However, non-surgical management options result in poor prognosis with only 3% survival at five-years. Pelvic exenteration in appropriately-selected patients offers the only hope of long-term survival. Over the last few decades with improved perioperative management and better surgical techniques, more aggressive visceral, soft tissue and bony resections are performed. The development of minimally invasive surgery (MIS) platforms has also evolved substantially, especially regarding pelvic surgery. There are some recent sporadic (low-volume) reports highlighting the potential role for MIS exenterative surgery, however many reports have been heterogeneous and single-centre. The aim of this retrospective review is to compare the volume, disease characteristics and surgical outcomes between open, laparoscopic and robotic pelvic exenterations, and to assess the initial experience of MIS platforms in multiple specialist centres worldwide.

Conditions

Timeline

Start date
2021-08-01
Primary completion
2021-12-01
Completion
2022-02-01
First posted
2021-07-02
Last updated
2021-10-20

Locations

1 site across 1 country: Ireland

Source: ClinicalTrials.gov record NCT04948762. Inclusion in this directory is not an endorsement.

A Contemporary Review of Surgical Approaches in Pelvic Exenterative Surgery (NCT04948762) · Clinical Trials Directory