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A Contemporary Review of Surgical Approaches in Pelvic Exenterative Surgery

S

St Vincent's University Hospital, Ireland

Status

Unknown

Conditions

Pelvic Exenteration
Advanced Pelvic Malignancy
Locally Advanced Rectal Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT04948762
PelvEx 5

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Histologically proven locally advanced or recurrent RECTAL cancer
  • Aged over 18 years
  • Undergoing a multi-visceral extended pelvic resection
  • Procedure took place within the specified timeframe (July 2016 - July 2021)

Exclusion criteria

  • Extra-pelvic/ non-resectable metastatic or peritoneal disease
  • Palliative pelvic exenteration
  • Insufficient patient follow-up data

Trial design

1,000 participants in 3 patient groups

Open
Description:
Patients who underwent an open approach to pelvic exenteration
Laparoscopic
Description:
Patients who underwent a laparoscopic approach to pelvic exenteration
Robotic
Description:
Patients who underwent a robotically-assisted pelvic exenteration

Trial contacts and locations

1

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Central trial contact

Michael Kelly, MD; Matthew Fahy, MD

Data sourced from clinicaltrials.gov

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