A Contemporary Review of Surgical Approaches in Pelvic Exenterative Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Locally Advanced Rectal Cancer; Pelvic Exenteration; Advanced Pelvic Malignancy

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Michael Kelly, MD; Email: kellym11@tcd.ie
• Study Contact Backup: Name: Matthew Fahy, MD; Phone Number: 00353874510237; Email: mfahy94@gmail.com

Study Locations

• Ireland
  • Dublin, Ireland, D4
    • Recruiting
    • St. Vincent's Hospital
    • Contact: Des Winter, MD; Email: pelvexcollaborative@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients over 18 years of age who are undergoing surgery for histologically-confirmed locally advanced or recurrent rectal cancer.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Open; Patients who underwent an open approach to pelvic exenteration
Laparoscopic; Patients who underwent a laparoscopic approach to pelvic exenteration
Robotic; Patients who underwent a robotically-assisted pelvic exenteration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resection status	Completeness of the surgical resection (R0, R1 or R2)	July 2016 - July 2021

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood loss	Blood loss (mL)	July 2016 - July 2021
Length of stay	Duration of stay in hospital post-procedure	July 2016 - July 2021
Operation time	Time from first incision to skin closure (minutes)	July 2016 - July 2021
Conversion rate	Need to convert from robotic or laparoscopic to open procedure	July 2016 - July 2021
Morbidity	Frequency of post-operative complication, as measured by the Clavien-Dindo scale	July 2016 - July 2021
Analgesic Requirements	Quantity of analgesia consumed, primarily opioid analgesia measured in morphine equivalents	July 2016 - July 2021
Return of bowel function	Time to passage of flatus or bowel motion	July 2016 - July 2021

Collaborators and Investigators

• Sponsor: St Vincent's University Hospital, Ireland
• Investigators: Study Chair: Desmond Winter, MD, St. Vincent's Healthcare Group

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: June 24, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): July 2, 2021

Study Record Updates

• Last Update Posted (Actual): October 20, 2021
• Last Update Submitted That Met QC Criteria: October 12, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: PelvEx 5

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No