Pelvic CancerNCT05074082
Perineal Flap Reconstruction Following Surgery for Advanced Pelvic Malignancy
An observational study of Pelvic Cancer and Rectal Cancer, run by St Vincent's University Hospital, Ireland at 1 site in Ireland.
Trial summary
Flap reconstruction is utilised increasingly for repair of skin and soft tissue defects following pelvic exenteration. Many methods have been proposed but the outcomes associated with each remain largely unknown and the choice dependant on surgeon preference and patient/ disease characteristics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pelvic Cancer, Rectal Cancer, Flap Disorder
- What is being tested?
- Flap reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 883 participants
- Where
- 1 siteIreland
- Study dates
- 31 Jul 2021to 1 Mar 2023
- 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
- Adult, Older adult
Study population: Patients undergoing flap reconstruction of a skin or soft tissue defect as part of a multi-visceral extended resection for pelvic malignancy.
Who may be able to join
- Histologically proven locally advanced or recurrent pelvic cancer (all subtypes - Rectal, Urological, Gynaecological, Sarcoma)
- Aged over 18 years
- Undergoing a multi-visceral extended pelvic resection and requiring reconstruction of a skin and soft tissue defect as a result
- Time period: 1st July 2016 - 1st July 2021
Who cannot join
- Strong evidence of metastatic or peritoneal disease
- No immediate flap reconstruction performed at time of extended pelvic resection/pelvic exenteration, or flap reconstruction performed as a delayed procedure or as a response to a complication of prior pelvic exenteration
- Insufficient patient follow-up (Minimum of 30 days)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PelvEx 8: Perineal Flap Reconstruction Following Surgery for Advanced Pelvic Malignancy
Flap reconstruction is utilised increasingly for repair of skin and soft tissue defects following pelvic exenteration. Many methods have been proposed but the outcomes associated with each remain largely unknown and the choice dependant on surgeon preference and patient/ disease characteristics. This review sought to assess the preferred methods for perineal reconstruction following pelvic exenteration by retrospectively assessing the outcomes associated with each at an international, multi-centre level.
Read the detailed description
Locally advanced pelvic malignancies pose numerous technical difficulties to oncological surgeons, particularly where extended resections are performed. The repair of skin and soft tissue defects after radical resections are among the most challenging. Complications related to wound healing are among the most commonly encountered. They can increase rates of infection in the short-term and often become chronic and difficult to treat. This is particularly relevant in the context of pelvic exenteration, where a larger dead space confers a greater risk of deep perineal wound infection and prior (chemo)radiotherapy impairs tissue quality with suboptimal healing. Primary closure may also lead to higher tension closure where there is a bigger defect, further compounding risk. The first meta-analysis comparing primary closure to flap closure noted a two-fold increased risk of overall wound complications with primary closure (1).
With increasingly extensive procedures being carried out in dedicated centres over recent decades, the use of flap reconstruction for closure of pelvic oncological defects has increased significantly. Perineal reconstruction has been shown to decrease the incidence the wound of break-down as well as the need for a secondary repair of dehiscence (2). More importantly, these complications have been shown to be decreasing over time, suggesting improved techniques and/or better perioperative care. However, this is countered by an increase in the incidence of overall minor complications and the possibility of flap failure necessitating a return to theatre. Flap formation is a morbid procedure in its own right and can involve more intensive nursing care and restrict a patient's mobility after pelvic exenteration, further predisposing to post-operative complications and increasing length-of-stay.
The Vertical Rectus Abdominis Muscle (VRAM) flap remains one of the most commonly used and is considered by some to be the gold standard. However, a wide variety of methods have been proposed but exactly how often each is employed and with what outcomes remains largely unknown and is of great interest to surgeons involved in pelvic reconstruction. This review sought to assess the preferred methods for perineal reconstruction following pelvic exenteration by retrospectively assessing the outcomes associated with each at an international, multi-centre level.
- Conditions
- Pelvic Cancer, Rectal Cancer, Flap Disorder, Flap Ischemia, Flap Necrosis, Perioperative Complication
- Being tested
- Flap reconstruction
- Medical subject headings
- Pelvic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flap reconstructionProcedure or surgery
Also called VRAM flap, ORAM flap, Gracilis flap, IGAP flap
Formation of a (myo-/fascio-)cutaneous flap for repair of a skin and soft tissue defect
| Study group | Role | What they receive |
|---|---|---|
| Flap reconstruction | Patients who had a flap formation as part of a multi-visceral extended resection for advanced pelvic (rectal, urological, gynaecological, sarcomatous origin) malignancy Receives: Procedure: Flap reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flap reconstruction by procedure
Type of flap formation
Measured: July 2016 - July 2021
Morbidity
Short-term (<30 days) outcomes associated with each type
Measured: July 2016 - July 2021
Clavien-Dindo grade III or greater
Need for re-intervention by flap type
Measured: July 2016 - July 2021
Major flap dehiscence
By flap type
Measured: July 2016 - July 2021
Secondary outcomes (1)
Length of stay
Duration of post-operative hospital stay by flap type
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 posted12 Oct 2021
- Study start31 Jul 2021
- Primary completion1 Jul 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic CancerStudies 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
- 883 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Vincent's University Hospital, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- PelvEx
- Responsible party
- Principal investigator, Professor Des Winter, St Vincent's University Hospital, Ireland
- Investigators
- Desmond C Winter, MD, Principal investigator, St. Vincent's Healthcare Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074082
- Sponsor's protocol ID
- PelvEx 8
- Status last verified
- Mar 2023
- First submitted
- 29 Sep 2021
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PelvEx 8: Perineal Flap Reconstruction Following Surgery for Advanced Pelvic Malignancy
- ClinicalTrials.gov ID
- NCT05074082
- Acronym / sponsor ID
- PelvEx 8
- Conditions
- Pelvic Cancer, Rectal Cancer, Flap Disorder, Flap Ischemia, Flap Necrosis, Perioperative Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 883 participants (actual)
- Lead sponsor
- St Vincent's University Hospital, IrelandUniversity, hospital or other
- Collaborators
- PelvEx
- Study start
- 31 Jul 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 12 Oct 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.
Flap reconstruction is utilised increasingly for repair of skin and soft tissue defects following pelvic exenteration. Many methods have been proposed but the outcomes associated with each remain largely unknown and the choice dependant on surgeon preference and patient/ disease characteristics. This review sought to assess the preferred methods for perineal reconstruction following pelvic exenteration by retrospectively assessing the outcomes associated with each at an international, multi-centre level.
Detailed description
Locally advanced pelvic malignancies pose numerous technical difficulties to oncological surgeons, particularly where extended resections are performed. The repair of skin and soft tissue defects after radical resections are among the most challenging. Complications related to wound healing are among the most commonly encountered. They can increase rates of infection in the short-term and often become chronic and difficult to treat. This is particularly relevant in the context of pelvic exenteration, where a larger dead space confers a greater risk of deep perineal wound infection and prior (chemo)radiotherapy impairs tissue quality with suboptimal healing. Primary closure may also lead to higher tension closure where there is a bigger defect, further compounding risk. The first meta-analysis comparing primary closure to flap closure noted a two-fold increased risk of overall wound complications with primary closure (1).
With increasingly extensive procedures being carried out in dedicated centres over recent decades, the use of flap reconstruction for closure of pelvic oncological defects has increased significantly. Perineal reconstruction has been shown to decrease the incidence the wound of break-down as well as the need for a secondary repair of dehiscence (2). More importantly, these complications have been shown to be decreasing over time, suggesting improved techniques and/or better perioperative care. However, this is countered by an increase in the incidence of overall minor complications and the possibility of flap failure necessitating a return to theatre. Flap formation is a morbid procedure in its own right and can involve more intensive nursing care and restrict a patient's mobility after pelvic exenteration, further predisposing to post-operative complications and increasing length-of-stay.
The Vertical Rectus Abdominis Muscle (VRAM) flap remains one of the most commonly used and is considered by some to be the gold standard. However, a wide variety of methods have been proposed but exactly how often each is employed and with what outcomes remains largely unknown and is of great interest to surgeons involved in pelvic reconstruction. This review sought to assess the preferred methods for perineal reconstruction following pelvic exenteration by retrospectively assessing the outcomes associated with each at an international, multi-centre level.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flap reconstruction | – | Procedure: Flap reconstructionPatients who had a flap formation as part of a multi-visceral extended resection for advanced pelvic (rectal, urological, gynaecological, sarcomatous origin) malignancy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing flap reconstruction of a skin or soft tissue defect as part of a multi-visceral extended resection for pelvic malignancy.
Key inclusion criteria (4 listed)
- Histologically proven locally advanced or recurrent pelvic cancer (all subtypes - Rectal, Urological, Gynaecological, Sarcoma)
- Aged over 18 years
- Undergoing a multi-visceral extended pelvic resection and requiring reconstruction of a skin and soft tissue defect as a result
- Time period: 1st July 2016 - 1st July 2021
Key exclusion criteria (3 listed)
- Strong evidence of metastatic or peritoneal disease
- No immediate flap reconstruction performed at time of extended pelvic resection/pelvic exenteration, or flap reconstruction performed as a delayed procedure or as a response to a complication of prior pelvic exenteration
- Insufficient patient follow-up (Minimum of 30 days)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flap reconstructionAlso: VRAM flap, ORAM flap, Gracilis flap, IGAP flapFormation of a (myo-/fascio-)cutaneous flap for repair of a skin and soft tissue defect | Procedure or surgery | Flap reconstruction |
Primary outcome
Flap reconstruction by procedure
Time frame: July 2016 - July 2021
Type of flap formation
Morbidity
Time frame: July 2016 - July 2021
Short-term (<30 days) outcomes associated with each type
Clavien-Dindo grade III or greater
Time frame: July 2016 - July 2021
Need for re-intervention by flap type
Major flap dehiscence
Time frame: July 2016 - July 2021
By flap type
1 secondary outcome
Length of stay
Time frame: July 2016 - July 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Desmond C Winter, MD principal investigator
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 Cancer and Rectal Cancer, 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: finished, as of the sponsor's last update on 31 Mar 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flap reconstruction by procedure (time frame: July 2016 - July 2021). The study lists 4 primary outcomes in all. 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 31 Mar 2023.