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Completed

NCT Number: NCT00588081

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

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.

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Key information

Conditions

Vaginal Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Vaginal Diseases Vaginal Neoplasms

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QOL

Behavioral

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.

Primary outcomes

  1. 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

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2016
Study completion
2016
First posted
Jan 8, 2008
Registry last updated
Aug 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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