Brief Title
Immediate Vaginal Reconstruction After Oncologic Resection: Surgical Outcomes, Patient Satisfaction and Sexual Function
Official Title
Immediate Vaginal Reconstruction Following Oncologic Resection: Surgical Outcomes, Patient Satisfaction and Sexual Function
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.
Study Type
Interventional
Primary Outcome
To determine perioperative and postoperative complication rates among patients having undergone immediate vaginal reconstruction following tumor resection and/or pelvic exenteration.
Secondary Outcome
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.
Condition
Vaginal Cancer
Intervention
QOL
Study Arms / Comparison Groups
1
Description: Participants will receive a cover letter, questionnaire and invitation to participate in a post-operative interview.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
27
Start Date
May 2001
Completion Date
August 2016
Primary Completion Date
August 2016
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: - None
Gender
Female
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Andrea Pusic, M.D., ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00588081
Organization ID
01-044
Responsible Party
Sponsor
Study Sponsor
Memorial Sloan Kettering Cancer Center
Study Sponsor
Andrea Pusic, M.D., Principal Investigator, Memorial Sloan Kettering Cancer Center
Verification Date
August 2016