- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02144974
Reconstruction of the Pelvic Floor After Total Pelvic Exenteration Using the TMG Flap
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.
Study Overview
Status
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients in the department of Gynecology in the University hospital of Tampere, who underwent total pelvic exenteration with reconstruction of the pelvic floor.
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Patients undergoing total pelvic exenteration
Patients undergoing total pelvic exenteration for gynecological malignancies and reconstruction of the pelvic floor with a TMG flap.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
wound healing
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
operative time
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 9R025
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Clinical Trials on Reconstruction of the Pelvic Floor After Total Pelvic Exenteration.
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Memorial Sloan Kettering Cancer CenterActive, not recruitingTotal Exenteration | Anterior or Posterior Pelvic Exenteration | Gynecologic Malignancies | Colorectal Malignancies | Urologic MalignanciesUnited States
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City, University of LondonMedical University of ViennaCompleted
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Qiu JinNot yet recruitingPelvic Floor Dysfunction | Mode of Delivery
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Bio-Medical Research, Ltd.Completed
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Federal University of São PauloCompletedCorrelation of Pelvic Floor Muscle Evaluation MethodsBrazil
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McMaster UniversityWithdrawnSegmental Dysfunction of the Pelvic Region
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Żelazna Medical Centre, LLCCompletedPelvic Floor Disorders | Pelvic Girdle Pain | Diastasis Recti and Weakness of the Linea AlbaPoland
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Assistance Publique - Hôpitaux de ParisNot yet recruitingPerinatal Solid Tumors of the Thoraco-abdomino-pelvic RegionFrance
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TriHealth Inc.CompletedQuality of Life | Pelvic Floor Distress and Impact Scores | Sexual Function ScoresUnited States
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Gerhard Pejcl Medizintechnik GmbHUnknownInternal Rectal Prolapse | Pelvic Floor Ptosis | Internal Hernia Into the Douglas PouchAustria