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Clinical Trials/NCT00588081
NCT00588081
Completed
Not Applicable

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

Memorial Sloan Kettering Cancer Center1 site in 1 country27 target enrollmentMay 2001
ConditionsVaginal Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vaginal Cancer
Sponsor
Memorial Sloan Kettering Cancer Center
Enrollment
27
Locations
1
Primary Endpoint
To determine perioperative and postoperative complication rates among patients having undergone immediate vaginal reconstruction following tumor resection and/or pelvic exenteration.
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2001
End Date
August 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

  • Not provided

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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)

Study Sites (1)

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