Reconstruction of the Pelvic Floor After Total Pelvic Exenteration Using the TMG Flap

May 21, 2014 updated by: Tampere University Hospital

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

Study Type

Observational

Enrollment (Actual)

12

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

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)

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

May 20, 2014

First Submitted That Met QC Criteria

May 21, 2014

First Posted (Estimate)

May 22, 2014

Study Record Updates

Last Update Posted (Estimate)

May 22, 2014

Last Update Submitted That Met QC Criteria

May 21, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 9R025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Reconstruction of the Pelvic Floor After Total Pelvic Exenteration.

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