Clinical trial NCT04948762: A Contemporary Review of Surgical Approaches in Pelvic Exenterative Surgery
Official title: A Contemporary Review of Surgical Approaches in Pelvic Exenterative Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Exenteration
Advanced Pelvic Malignancy
Locally Advanced Rectal Cancer
Lead sponsor: St Vincent's University Hospital, Ireland
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Resection status
timeFrame: July 2016 - July 2021
Secondary outcomes:
measure: Blood loss
timeFrame: July 2016 - July 2021
measure: Operation time
timeFrame: July 2016 - July 2021
measure: Conversion rate
timeFrame: July 2016 - July 2021
measure: Morbidity
timeFrame: July 2016 - July 2021
measure: Length of stay
timeFrame: July 2016 - July 2021
measure: Analgesic Requirements
timeFrame: July 2016 - July 2021
measure: Return of bowel function
timeFrame: July 2016 - July 2021
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: St. Vincent's Hospital
Study officials:
affiliation: St. Vincent's Healthcare Group
name: Desmond Winter, MD
role: STUDY_CHAIR
References: