MedDataX Logo

A Contemporary Review of Surgical Approaches in Pelvic Exenterative Surgery

NCT ID: NCT04948762

Last Updated: 2021-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pelvic Exenteration Advanced Pelvic Malignancy Locally Advanced Rectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Open

Patients who underwent an open approach to pelvic exenteration

No interventions assigned to this group

Laparoscopic

Patients who underwent a laparoscopic approach to pelvic exenteration

No interventions assigned to this group

Robotic

Patients who underwent a robotically-assisted pelvic exenteration

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

St Vincent's University Hospital, Ireland

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Professor Des Winter

Professor Desmond C Winter

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Desmond Winter, MD

Role: STUDY_CHAIR

St. Vincent's Healthcare Group

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

St. Vincent's Hospital

Dublin, , Ireland

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Ireland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Matthew Fahy, MD

Role: CONTACT

[email protected]
00353874510237

Michael Kelly, MD

Role: CONTACT

[email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Des Winter, MD

Role: primary

[email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PelvEx 5

Identifier Type: -

Identifier Source: org_study_id