A Contemporary Review of Surgical Approaches in Pelvic Exenterative Surgery

Sponsor
St Vincent's University Hospital, Ireland (Other)
Overall Status
Recruiting
CT.gov ID
NCT04948762
Collaborator
(none)
1,000
1
6
165.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    A Contemporary Review of Surgical Approaches in Pelvic Exenterative Surgery
    Actual Study Start Date :
    Aug 1, 2021
    Anticipated Primary Completion Date :
    Dec 1, 2021
    Anticipated Study Completion Date :
    Feb 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Open

    Patients who underwent an open approach to pelvic exenteration

    Laparoscopic

    Patients who underwent a laparoscopic approach to pelvic exenteration

    Robotic

    Patients who underwent a robotically-assisted pelvic exenteration

    Outcome Measures

    Primary Outcome Measures

    1. Resection status [July 2016 - July 2021]

      Completeness of the surgical resection (R0, R1 or R2)

    Secondary Outcome Measures

    1. Blood loss [July 2016 - July 2021]

      Blood loss (mL)

    2. Operation time [July 2016 - July 2021]

      Time from first incision to skin closure (minutes)

    3. Conversion rate [July 2016 - July 2021]

      Need to convert from robotic or laparoscopic to open procedure

    4. Morbidity [July 2016 - July 2021]

      Frequency of post-operative complication, as measured by the Clavien-Dindo scale

    5. Length of stay [July 2016 - July 2021]

      Duration of stay in hospital post-procedure

    6. Analgesic Requirements [July 2016 - July 2021]

      Quantity of analgesia consumed, primarily opioid analgesia measured in morphine equivalents

    7. Return of bowel function [July 2016 - July 2021]

      Time to passage of flatus or bowel motion

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St. Vincent's Hospital Dublin Ireland D4

    Sponsors and Collaborators

    • St Vincent's University Hospital, Ireland

    Investigators

    • Study Chair: Desmond Winter, MD, St. Vincent's Healthcare Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Professor Des Winter, Professor Desmond C Winter, St Vincent's University Hospital, Ireland
    ClinicalTrials.gov Identifier:
    NCT04948762
    Other Study ID Numbers:
    • PelvEx 5
    First Posted:
    Jul 2, 2021
    Last Update Posted:
    Oct 20, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 20, 2021