A Contemporary Review of Surgical Approaches in Pelvic Exenterative Surgery

Study Overview
=================
Brief 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.

Official Title
-----------------
A Contemporary Review of Surgical Approaches in Pelvic Exenterative Surgery

Conditions
-----------------
Pelvic Exenteration, Advanced Pelvic Malignancy, Locally Advanced Rectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Open<br>Patients who underwent an open approach to pelvic exenteration | |
| Laparoscopic<br>Patients who underwent a laparoscopic approach to pelvic exenteration | |
| Robotic<br>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 | 
| 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 | 
| Length of stay | Duration of stay in hospital post-procedure | 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 |