Reconstruction of the Pelvic Floor After Total Pelvic Exenteration.NCT02144974
Reconstruction of the Pelvic Floor After Total Pelvic Exenteration Using the TMG Flap
An observational study of Reconstruction of the Pelvic Floor After Total Pelvic Exenteration., run by Tampere University Hospital.
Trial summary
Total pelvic exenteration (TPE) is a rare operation, which is the only possible curative intervention to treat central residual or recurrent tumors of the vulvar, vaginal, cervical, or uterine malignancies after initial surgery, radiation therapy and chemotherapy. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Reconstruction of the Pelvic Floor After Total Pelvic Exenteration.
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to May 2014
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients in the department of Gynecology in the University hospital of Tampere, who underwent total pelvic exenteration with reconstruction of the pelvic floor (no:12)
Who may be able to join
- Patients in the department of Gynecology in the University hospital of Tampere, who underwent total pelvic exenteration with reconstruction of the pelvic floor.
Who cannot join
- -
About this study
Official title: Reconstruction of the Pelvic Floor and the Vagina After Total Pelvic Exenteration Using the Transverse Musculocutaneous Gracilis Flap
Total pelvic exenteration (TPE) is a rare operation, which is the only possible curative intervention to treat central residual or recurrent tumors of the vulvar, vaginal, cervical, or uterine malignancies after initial surgery, radiation therapy and chemotherapy. Several options for pelvic floor and vaginal reconstruction have been described. The transverse musculocutaneous gracilis (TMG) flap has been introduced for breast reconstruction as a free flap. The investigators adopted the pedicled TMG flap for reconstruction after TPE.
Between November 2011 and February 2014, twelve patients underwent TPE and reconstruction with unilateral (6 patients) or bilateral (6 patients) pedicled TMG flaps. Five patients had vaginal reconstruction with bilateral TMG flaps. The investigators describe the operative procedure and the outcome of the operation in these patients.
- Keywords
- Total pelvic exenteration.
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 |
|---|---|---|
| Patients undergoing total pelvic exenteration | Patients undergoing total pelvic exenteration for gynecological malignancies and reconstruction of the pelvic floor with a TMG flap. |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound healing
Measured: 6 months
Secondary outcomes (1)
operative time
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study startFeb 2014
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reconstruction of the Pelvic Floor After Total Pelvic Exenteration.Studies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02144974
- Sponsor's protocol ID
- 9R025
- Status last verified
- May 2014
- First submitted
- 20 May 2014
- Last updated
- 22 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconstruction of the Pelvic Floor and the Vagina After Total Pelvic Exenteration Using the Transverse Musculocutaneous Gracilis Flap
- ClinicalTrials.gov ID
- NCT02144974
- Acronym / sponsor ID
- 9R025
- Keywords
- Total pelvic exenteration.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 22 May 2014 (estimated)
- 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.
Total pelvic exenteration (TPE) is a rare operation, which is the only possible curative intervention to treat central residual or recurrent tumors of the vulvar, vaginal, cervical, or uterine malignancies after initial surgery, radiation therapy and chemotherapy. Several options for pelvic floor and vaginal reconstruction have been described. The transverse musculocutaneous gracilis (TMG) flap has been introduced for breast reconstruction as a free flap. The investigators adopted the pedicled TMG flap for reconstruction after TPE.
Between November 2011 and February 2014, twelve patients underwent TPE and reconstruction with unilateral (6 patients) or bilateral (6 patients) pedicled TMG flaps. Five patients had vaginal reconstruction with bilateral TMG flaps. The investigators describe the operative procedure and the outcome of the operation in these patients.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing total pelvic exenteration | – | –Patients undergoing total pelvic exenteration for gynecological malignancies and reconstruction of the pelvic floor with a TMG flap. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients in the department of Gynecology in the University hospital of Tampere, who underwent total pelvic exenteration with reconstruction of the pelvic floor (no:12)
Key inclusion criteria (1 listed)
- Patients in the department of Gynecology in the University hospital of Tampere, who underwent total pelvic exenteration with reconstruction of the pelvic floor.
Key exclusion criteria (1 listed)
- -
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
wound healing
Time frame: 6 months
1 secondary outcome
operative time
Time frame: 1 day
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 22 May 2014.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Reconstruction of the Pelvic Floor After Total Pelvic Exenteration., run by Tampere University Hospital.
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 1 inclusion and 1 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 22 May 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
wound healing (time frame: 6 months). 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 22 May 2014.