A Contemporary Review of Surgical Approaches in Pelvic Exenterative Surgery
- Conditions
- Locally Advanced Rectal CancerAdvanced Pelvic MalignancyPelvic Exenteration
- Registration Number
- NCT04948762
- Lead Sponsor
- St Vincent's University Hospital, Ireland
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
- 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)
- Extra-pelvic/ non-resectable metastatic or peritoneal disease
- Palliative pelvic exenteration
- Insufficient patient follow-up data
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Resection status July 2016 - July 2021 Completeness of the surgical resection (R0, R1 or R2)
- Secondary Outcome Measures
Name Time Method Operation time July 2016 - July 2021 Time from first incision to skin closure (minutes)
Return of bowel function July 2016 - July 2021 Time to passage of flatus or bowel motion
Morbidity July 2016 - July 2021 Frequency of post-operative complication, as measured by the Clavien-Dindo scale
Blood loss July 2016 - July 2021 Blood loss (mL)
Conversion rate July 2016 - July 2021 Need to convert from robotic or laparoscopic to open procedure
Length of stay July 2016 - July 2021 Duration of stay in hospital post-procedure
Analgesic Requirements July 2016 - July 2021 Quantity of analgesia consumed, primarily opioid analgesia measured in morphine equivalents
Trial Locations
- Locations (1)
St. Vincent's Hospital
🇮🇪Dublin, Ireland