Pelvic ExenterationNCT04948762
A Contemporary Review of Surgical Approaches in Pelvic Exenterative Surgery
An observational study of Pelvic Exenteration and Advanced Pelvic Malignancy, run by St Vincent's University Hospital, Ireland at 1 site in Ireland.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pelvic Exenteration, Advanced Pelvic Malignancy, Locally Advanced Rectal Cancer
- How many people
- 1,000 participants
- Where
- 1 siteIreland
- Study dates
- 1 Aug 2021to 1 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 18 years of age who are undergoing surgery for histologically-confirmed locally advanced or recurrent rectal cancer.
Who may be able to join
- 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)
Who cannot join
- Extra-pelvic/ non-resectable metastatic or peritoneal disease
- Palliative pelvic exenteration
- Insufficient patient follow-up data
Trial locations and contacts
1 site in 1 country.
Michael Kelly, MD contact
Ireland1 site, 1 recruiting
- Recruiting
St. Vincent's Hospital
Dublin, D4
Des Winter, MD, pelvexcollaborative@gmail.com
About this study
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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resection status
Completeness of the surgical resection (R0, R1 or R2)
Measured: July 2016 - July 2021
Secondary outcomes (7)
Blood loss
Blood loss (mL)
Measured: July 2016 - July 2021
Operation time
Time from first incision to skin closure (minutes)
Measured: July 2016 - July 2021
Conversion rate
Need to convert from robotic or laparoscopic to open procedure
Measured: July 2016 - July 2021
Morbidity
Frequency of post-operative complication, as measured by the Clavien-Dindo scale
Measured: July 2016 - July 2021
Length of stay
Duration of stay in hospital post-procedure
Measured: July 2016 - July 2021
Analgesic Requirements
Quantity of analgesia consumed, primarily opioid analgesia measured in morphine equivalents
Measured: July 2016 - July 2021
Return of bowel function
Time to passage of flatus or bowel motion
Measured: July 2016 - July 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start1 Aug 2021
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic ExenterationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Vincent's University Hospital, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Des Winter, St Vincent's University Hospital, Ireland
- Investigators
- Desmond Winter, MD, Study chair, St. Vincent's Healthcare Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948762
- Sponsor's protocol ID
- PelvEx 5
- Status last verified
- Oct 2021
- First submitted
- 24 Jun 2021
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Contemporary Review of Surgical Approaches in Pelvic Exenterative Surgery
- ClinicalTrials.gov ID
- NCT04948762
- Acronym / sponsor ID
- PelvEx 5
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- St Vincent's University Hospital, IrelandUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 2 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years of age who are undergoing surgery for histologically-confirmed locally advanced or recurrent rectal cancer.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- Extra-pelvic/ non-resectable metastatic or peritoneal disease
- Palliative pelvic exenteration
- Insufficient patient follow-up data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Resection status
Time frame: July 2016 - July 2021
Completeness of the surgical resection (R0, R1 or R2)
7 secondary outcomes
Blood loss
Time frame: July 2016 - July 2021
Operation time
Time frame: July 2016 - July 2021
Conversion rate
Time frame: July 2016 - July 2021
Morbidity
Time frame: July 2016 - July 2021
Length of stay
Time frame: July 2016 - July 2021
Analgesic Requirements
Time frame: July 2016 - July 2021
Return of bowel function
Time frame: July 2016 - July 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Kelly, MD contact
Desmond Winter, MD study chair
St. Vincent's Healthcare Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Exenteration and Advanced Pelvic Malignancy, run by St Vincent's University Hospital, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthew Fahy, MD (00353874510237, mfahy94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resection status (time frame: July 2016 - July 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.