A Contemporary Review of Surgical Approaches in Pelvic Exenterative Surgery

Locally Advanced Rectal Cancer Clinical Trial

Official title:

A Contemporary Review of Surgical Approaches in Pelvic Exenterative Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04948762
• Other study ID #: PelvEx 5
• Status: Recruiting
• Start date: August 1, 2021
• Est. completion date: February 1, 2022

Study information

• Verified date: October 2021
• Source: St Vincent's University Hospital, Ireland
• Contact: Matthew Fahy, MD
• Phone: 00353874510237
• Email: mfahy94[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: February 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Locally Advanced Rectal Cancer
• Neoplasms
• Rectal Neoplasms

Locations

Country	Name	City	State
Ireland	St. Vincent's Hospital	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
St Vincent's University Hospital, Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resection status	Completeness of the surgical resection (R0, R1 or R2)	July 2016 - July 2021
Secondary	Blood loss	Blood loss (mL)	July 2016 - July 2021
Secondary	Operation time	Time from first incision to skin closure (minutes)	July 2016 - July 2021
Secondary	Conversion rate	Need to convert from robotic or laparoscopic to open procedure	July 2016 - July 2021
Secondary	Morbidity	Frequency of post-operative complication, as measured by the Clavien-Dindo scale	July 2016 - July 2021
Secondary	Length of stay	Duration of stay in hospital post-procedure	July 2016 - July 2021
Secondary	Analgesic Requirements	Quantity of analgesia consumed, primarily opioid analgesia measured in morphine equivalents	July 2016 - July 2021
Secondary	Return of bowel function	Time to passage of flatus or bowel motion	July 2016 - July 2021