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Immediate Vaginal Reconstruction After Oncologic Resection: Surgical Outcomes, Patient Satisfaction and Sexual Function

Immediate Vaginal Reconstruction Following Oncologic Resection: Surgical Outcomes, Patient Satisfaction and Sexual Function

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00588081
Enrollment
27
Registered
2008-01-08
Start date
2001-05-31
Completion date
2016-08-31
Last updated
2016-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginal Cancer

Keywords

Vaginal Reconstruction

Brief summary

This study is being done to find out more about the experience women have with vaginal reconstruction. We hope to learn about their quality of life, sexual function, and body image. We would like to find out how happy women are with surgery. We also want to know what things should be changed or improved. Since you have had this surgery, we would like to ask you to take part in an interview.

Detailed description

The purpose of this study, entitled immediate vaginal reconstruction following oncologic resection: Surgical outcomes, patient satisfaction and sexual function is to determine postoperative complications, patient satisfaction, quality of life and level of sexual functioning among patients who have undergone vaginal reconstruction following tumor resection and/or pelvic exenteration.This study will have three components: 1) a chart review to determine postoperative complications and anatomic characteristics of the neo-vagina, 2) a postoperative questionnaire consisting of validated survey instruments to assess quality of life, body image and sexual function and 3) a postoperative qualitative interview to examine quality of life after vaginal reconstruction.

Interventions

BEHAVIORALQOL

Those women who chose to have an interview will be scheduled for a 45 to 60 minute open-ended interview with a trained research assistant and sign consent at the time of the interview.

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

* Immediate partial or total vaginal reconstruction with myocutaneous or fasciocutaneous flaps, following pelvic exenteration or tumor resection at MSKCC during the study period from January 1, 1993 to, March 30, 2007.

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frame
To determine perioperative and postoperative complication rates among patients having undergone immediate vaginal reconstruction following tumor resection and/or pelvic exenteration.A single questionnaire and or interview

Secondary

MeasureTime frame
To determine patient satisfaction, quality of life and level of sexual functioning among patients having undergone immediate vaginal reconstruction following tumor resection and/or pelvic exenteration.Single Questionnaire and or interview
To determine the physical adequacy of the neo-vagina among patients having undergone immediate vaginal reconstruction following tumor resection and/or pelvic exenteration.A single questionnaire and or interview

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026