Pelvic CancerNCT05074069
A Review of Functional and Surgical Outcomes of Gynaecological Reconstruction in the Context of Pelvic Exenteration
An observational study of Pelvic Cancer, run by St Vincent's University Hospital, Ireland at 1 site in Ireland.
Trial summary
Patients with locally advanced pelvic malignancy undergo radical procedures, necessitate organ reconstruction. Little is known about the preferred methods of gynaecological organ reconstruction in the context of pelvic exenteration. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Cancer
- What is being tested?
- Gynaecological reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 334 participants
- Where
- 1 siteIreland
- Study dates
- 1 Jul 2021to 1 Sep 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 18 years of age who have undergone pelvic exenteration/multi-visceral resection with gynaecological organ reconstruction for a locally advanced pelvic malignancy in a participating PelvEx centre between July 2016 and July 2021.
Who may be able to join
- Histologically proven locally advanced or recurrent pelvic cancer (all subtypes - Rectal, Urological, Gynae, Sarcome)
- Aged over 18 years
- Undergoing a multi-visceral extended pelvic resection and requiring gynaecological reconstruction at the time of index operation
- Time period: 1st July 2016 - 31st July 2021
Who cannot join
- Strong evidence of metastatic or peritoneal disease
- No histological evidence of gynaecological organ involvement
- Procedure not carried out with curative intent
- Insufficient patient follow-up (Minimum of 30 days)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PelvEx 7: A Review of Functional and Surgical Outcomes of Gynaecological Reconstruction in the Context of Pelvic Exenteration
Patients with locally advanced pelvic malignancy undergo radical procedures, necessitate organ reconstruction. Little is known about the preferred methods of gynaecological organ reconstruction in the context of pelvic exenteration. This review aims to identify which methods are commonly used and what outcomes are associated with each technique in order to further guide future practice.
Read the detailed description
The mainstay of treatment for patients with locally advanced pelvic malignancy is radical surgical excision combined, with (neo)adjuvant chemoradiotherapy where appropriate. The primary objective is to obtain a negative resection margin (R0) in order to achieve long-term survival. Centralisation of care and refinements in surgical technique have enabled surgeons specializing in advanced pelvic oncology to embark upon more aggressive approaches to accomplishing an R0 resection.
With improved oncological outcomes has come an increased focus on quality-of-life (QoL), functional sequelae and patient experience and survivorship. Adequate experience and proficiency with reconstructive techniques has become one of the key components for surgeons practicing in pelvic oncology. Reconstructive procedures should be undertaken with the goals of improving wound healing, reducing morbidity and restoring anatomic form and function. These factors are of utmost importance in the context of pelvic exenteration, where wound complications are prevalent as a result of a larger pelvic dead space and the potential for contamination. Adverse impact on sexual function following pelvic surgery is also common where the autonomic nerves are involved. This is further compounded by the need to resect part or all of the vulvovaginar complex as part of an extirpative procedure, with resultant declines in QoL and overall psychosexual wellbeing.
A number of methods have been proposed for reconstruction of the pelvic floor and vulva/vagina in females, including skin grafting, skin flaps, fasciocutaneous and myocutaneous flaps, as well as the formation of a neovagina in specific circumstances. Thereis a paucity of data with regard to the optimal approach to gynaecological organ reconstruction, with the majority of the literature referring to single-centre, retrospective series. This review sought to assess the preferred methods for gynaecological reconstruction at an international level, the clinical and technical particulars leading to the choice of each method and the short-term outcomes associated with each technique.
- Conditions
- Pelvic Cancer
- Being tested
- Gynaecological reconstruction
- Medical subject headings
- Pelvic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gynaecological reconstructionProcedure or surgery
Methods of vulvovaginal reconstruction, e.g. flap formation, neovagina formation
| Study group | Role | What they receive |
|---|---|---|
| Neovaginal reconstruction | Neovaginal reconstruction post-vulvovaginal resection Receives: Procedure: Gynaecological reconstruction | |
| Flap Reconstruction | Flap closure of perineal defect post-gynaecological organ resection Receives: Procedure: Gynaecological reconstruction | |
| No reconstruction/Primary closure | Primary closure of defect post-multivisceral, gynaecological organ-involving, resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity
Number of patients experiencing short-term (up to 30 days postoperatively) morbidity
Measured: July 2016 - July 2021
Gynaecological Reconstruction
Number of patients with each method of reconstruction
Measured: July 2016 - July 2021
Perineal wound complications
Number of patients with superficial wound infections, abscess, dehiscence by type of reconstruction
Measured: July 2016 - July 2021
Secondary outcomes (4)
Dyspareunia
Dyspareunia
Measured: July 2016 - July 2021
Return to intercourse
Return to intercourse
Measured: July 2016 - July 2021
Pelvic pain
Chronic pelvic pain by type of reconstruction
Measured: July 2016 - July 2021
Histological outcomes
Radicality of resection, e.g. R0, R1 or R2, and histological subtypes
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 start1 Jul 2021
- Primary completion1 Jul 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 334 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074069
- Sponsor's protocol ID
- PelvEx 7
- 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: Patients will be identified by a key from the nominated study coordinator from each site, with no individual or identifiable data to be shared between researchers.
Publications
PelvEx Collaborative. A review of functional and surgical outcomes of gynaecological reconstruction in the context of pelvic exenteration. Surg Oncol. 2024 Feb;52:101996. doi: 10.1016/j.suronc.2023.101996. Epub 2023 Nov 22.
PubMed 38096764
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 7: A Review of Functional and Surgical Outcomes of Gynaecological Reconstruction in the Context of Pelvic Exenteration
- ClinicalTrials.gov ID
- NCT05074069
- Acronym / sponsor ID
- PelvEx 7
- Conditions
- Pelvic Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- St Vincent's University Hospital, IrelandUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Sep 2022 (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.
Patients with locally advanced pelvic malignancy undergo radical procedures, necessitate organ reconstruction. Little is known about the preferred methods of gynaecological organ reconstruction in the context of pelvic exenteration. This review aims to identify which methods are commonly used and what outcomes are associated with each technique in order to further guide future practice.
Detailed description
The mainstay of treatment for patients with locally advanced pelvic malignancy is radical surgical excision combined, with (neo)adjuvant chemoradiotherapy where appropriate. The primary objective is to obtain a negative resection margin (R0) in order to achieve long-term survival. Centralisation of care and refinements in surgical technique have enabled surgeons specializing in advanced pelvic oncology to embark upon more aggressive approaches to accomplishing an R0 resection.
With improved oncological outcomes has come an increased focus on quality-of-life (QoL), functional sequelae and patient experience and survivorship. Adequate experience and proficiency with reconstructive techniques has become one of the key components for surgeons practicing in pelvic oncology. Reconstructive procedures should be undertaken with the goals of improving wound healing, reducing morbidity and restoring anatomic form and function. These factors are of utmost importance in the context of pelvic exenteration, where wound complications are prevalent as a result of a larger pelvic dead space and the potential for contamination. Adverse impact on sexual function following pelvic surgery is also common where the autonomic nerves are involved. This is further compounded by the need to resect part or all of the vulvovaginar complex as part of an extirpative procedure, with resultant declines in QoL and overall psychosexual wellbeing.
A number of methods have been proposed for reconstruction of the pelvic floor and vulva/vagina in females, including skin grafting, skin flaps, fasciocutaneous and myocutaneous flaps, as well as the formation of a neovagina in specific circumstances. Thereis a paucity of data with regard to the optimal approach to gynaecological organ reconstruction, with the majority of the literature referring to single-centre, retrospective series. This review sought to assess the preferred methods for gynaecological reconstruction at an international level, the clinical and technical particulars leading to the choice of each method and the short-term outcomes associated with each technique.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neovaginal reconstruction | – | Procedure: Gynaecological reconstructionNeovaginal reconstruction post-vulvovaginal resection |
| Flap Reconstruction | – | Procedure: Gynaecological reconstructionFlap closure of perineal defect post-gynaecological organ resection |
| No reconstruction/Primary closure | – | –Primary closure of defect post-multivisceral, gynaecological organ-involving, resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years of age who have undergone pelvic exenteration/multi-visceral resection with gynaecological organ reconstruction for a locally advanced pelvic malignancy in a participating PelvEx centre between July 2016 and July 2021.
Key inclusion criteria (4 listed)
- Histologically proven locally advanced or recurrent pelvic cancer (all subtypes - Rectal, Urological, Gynae, Sarcome)
- Aged over 18 years
- Undergoing a multi-visceral extended pelvic resection and requiring gynaecological reconstruction at the time of index operation
- Time period: 1st July 2016 - 31st July 2021
Key exclusion criteria (4 listed)
- Strong evidence of metastatic or peritoneal disease
- No histological evidence of gynaecological organ involvement
- Procedure not carried out with curative intent
- 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 |
|---|---|---|
| Gynaecological reconstructionMethods of vulvovaginal reconstruction, e.g. flap formation, neovagina formation | Procedure or surgery | Flap Reconstruction, Neovaginal reconstruction |
Primary outcome
Morbidity
Time frame: July 2016 - July 2021
Number of patients experiencing short-term (up to 30 days postoperatively) morbidity
Gynaecological Reconstruction
Time frame: July 2016 - July 2021
Number of patients with each method of reconstruction
Perineal wound complications
Time frame: July 2016 - July 2021
Number of patients with superficial wound infections, abscess, dehiscence by type of reconstruction
4 secondary outcomes
Dyspareunia
Time frame: July 2016 - July 2021
Return to intercourse
Time frame: July 2016 - July 2021
Pelvic pain
Time frame: July 2016 - July 2021
Histological outcomes
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.
- Derived from this study: PubMed 38096764PelvEx Collaborative. A review of functional and surgical outcomes of gynaecological reconstruction in the context of pelvic exenteration. Surg Oncol. 2024 Feb;52:101996. doi: 10.1016/j.suronc.2023.101996. Epub 2023 Nov 22.
- Individual participant dataSharing planned: No. Patients will be identified by a key from the nominated study coordinator from each site, with no individual or identifiable data to be shared between researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, 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 4 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?
Morbidity (time frame: July 2016 - July 2021). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05074069, which also lists 1 linked publication.
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.