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A Contemporary Review of Surgical Approaches in Pelvic Exenterative Surgery

A Contemporary Review of Surgical Approaches in Pelvic Exenterative Surgery

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04948762
Enrollment
1000
Registered
2021-07-02
Start date
2021-08-01
Completion date
2022-02-01
Last updated
2021-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Pelvic Malignancy, Locally Advanced Rectal Cancer, Pelvic Exenteration

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.

Interventions

None listed

Sponsors

St Vincent's University Hospital, Ireland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Resection statusJuly 2016 - July 2021Completeness of the surgical resection (R0, R1 or R2)

Secondary

MeasureTime frameDescription
Operation timeJuly 2016 - July 2021Time from first incision to skin closure (minutes)
Conversion rateJuly 2016 - July 2021Need to convert from robotic or laparoscopic to open procedure
MorbidityJuly 2016 - July 2021Frequency of post-operative complication, as measured by the Clavien-Dindo scale
Blood lossJuly 2016 - July 2021Blood loss (mL)
Analgesic RequirementsJuly 2016 - July 2021Quantity of analgesia consumed, primarily opioid analgesia measured in morphine equivalents
Return of bowel functionJuly 2016 - July 2021Time to passage of flatus or bowel motion
Length of stayJuly 2016 - July 2021Duration of stay in hospital post-procedure

Countries

Ireland

Contacts

Primary ContactMatthew Fahy, MD
mfahy94@gmail.com00353874510237
Backup ContactMichael Kelly, MD
kellym11@tcd.ie

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026