Immediate Vaginal Reconstruction After Oncologic Resection: Surgical Outcomes, Patient Satisfaction and Sexual Function
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Vaginal Cancer |
Behavioral: QOL |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Immediate Vaginal Reconstruction Following Oncologic Resection: Surgical Outcomes, Patient Satisfaction and Sexual Function |
- To determine perioperative and postoperative complication rates among patients having undergone immediate vaginal reconstruction following tumor resection and/or pelvic exenteration. [ Time Frame: A single questionnaire and or interview ] [ Designated as safety issue: No ]
- 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. [ Time Frame: Single Questionnaire and or interview ] [ Designated as safety issue: No ]
- To determine the physical adequacy of the neo-vagina among patients having undergone immediate vaginal reconstruction following tumor resection and/or pelvic exenteration. [ Time Frame: A single questionnaire and or interview ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | May 2001 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
Participants will receive a cover letter, questionnaire and invitation to participate in a post-operative interview.
|
Behavioral: QOL
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.
|
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts 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
Contacts and Locations| Contact: Andrea Pusic, M.D. | 212-639-5085 |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Andrea Pusic, M.D. 212-639-5085 | |
| Principal Investigator: Andrea Pusic, M.D. | |
| Principal Investigator: | Andrea Pusic, M.D. | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00588081 History of Changes |
| Other Study ID Numbers: | 01-044 |
| Study First Received: | December 22, 2007 |
| Last Updated: | January 31, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
Vaginal Reconstruction |
Additional relevant MeSH terms:
|
Vaginal Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site |
Neoplasms Vaginal Diseases Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 16, 2013